The statements below are based on individual experiences. Results may vary. Armin & Maby, MAVENCLAD patients since 2019.

My name is Beki. I live in Oklahoma. I was diagnosed with relapsing MS in 2000. I started MAVENCLAD in 2021. I was four years into my nursing career at the time of my diagnosis. I had started feeling a lot of fatigue, weakness, tremor, and I was encouraged by my family and friends to go to the doctor. I started with visiting my primary care physician who ordered an MRI. And she said, “Well, the good news is is you don’t have MS.” And I was like, “Hmm, I didn’t even know you were testing me for MS or checking that out.” So she said, “You know I think these symptoms are probably due to stress.” Well, my gut told me, “No, something’s going on.” So with the encouragement of family, friends, and some nursing colleagues, I sought out a second opinion. A few days later, I had a lumbar puncture that confirmed my diagnosis of...relapsing multiple sclerosis. And so that kind of started my journey.

When I was first diagnosed...I felt hopeless. I was lonely. I was afraid. I was very discouraged. Being someone in my mid-20s... had my full life ahead of me, and now I was facing this unpredictable diagnosis of relapsing MS. There were very few treatments available. There were only injections. There were no oral therapies. I’ve been on a weekly injection. I’ve been on an injection I took daily, and an injection I took three times a week. In the spring of 2021, I started having more symptoms. And I had an MRI at that time that showed progression of disease. So, I talked with my doctor’s physician’s assistant and he told me what options were available for treatment. I had no interest in going in for an infusion. I had no interest in taking any more injections. I was so thankful for an option of an oral therapy... and that’s why I chose MAVENCLAD. There’s no injections, there’s no infusion. It’s a very convenient dosing schedule with five days one month…The next month, five more days, and then you’re done till the next year…and then you just have to repeat it one more year.

Before starting MAVENCLAD, I talked to my doctor about the potential side effects, including cancer and the risk of birth defects. I was screened before, during, and after MAVENCLAD and regularly monitored by my doctor. I love the fact that with MAVENCLAD, I didn’t have to take off any work for appointments, for infusions or lab. I did experience some side effects that I have talked to my doctor about. Since finishing MAVENCLAD...I’ve not had any increase in symptoms and I’ve had an MRI that shows that my MS is stable. I’ve been able to continue to exercise by taking daily walks... I love to stretch, which helps with my flexibility. I also love to hike and stay active that way though I’m not hiking crazy mountains and whatnot. I just love being out in nature and MAVENCLAD has helped me continue to do those things. This is my experience. Your experience may be different.

I definitely feel encouraged. And one of the things I have learned is to surround myself with positive people. Having positive people in your life can make a huge difference in any kind of stress that you may have. So my advice to someone with this disease...is don’t be afraid. Don’t give up hope. Don’t be discouraged. Surround yourself with positive people.

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

 

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.


Real patients talk about MAVENCLAD

From switching treatments to seeing results, people taking MAVENCLAD share their experiences. MAVENCLAD Ambassadors are sponsored by EMD Serono, Inc.

Hello, my name is Eric. I live in Albuquerque, New Mexico. And 2001 is the year when I was diagnosed with having relapsing-remitting multiple sclerosis. Fast forward to a few years in the future and I started MAVENCLAD. 2021, a new journey in my life.

Before I was diagnosed with relapsing-remitting multiple sclerosis, I was heavily involved in martial arts. I really thought it was going to be my future. It wasn’t until late 2000 when I started to feel numbness and tingling on one side of my body, I was having trouble walking. I would drag half my body behind me…my speech had become more and more distorted, and my ability to focus and problem solve diminished. I had the kind of job where you really need to be focused. And it finally took someone that I was working with to say, “What is wrong with you? Something’s wrong with you, man.” That’s when I was diagnosed with having a stroke. I had a lot of hope because I was young and I was strong, and I feel like I could really recover from this and continue my life plan. This didn’t have to get in my way. Life began to go on. Being treated still as a stroke patient that I got a new family doctor. And once she took a look at my history, she just said, “Well, I think the stroke might not be the best diagnosis for you. I want to check and see if maybe multiple sclerosis may be playing a part in it. So she decided to send me to have an MRI and a spinal tap. When I was notified that the doctor wanted to see me again the next day, and just based on the tone in her voice, I kind of figured that my test came back positive for MS.

 

When I was first put on a treatment for multiple sclerosis, it was an injectable. I started with the best of intentions but…what happened was because of the pain from the injection site, the frequency of taking the injectables...I would dread having to do it when it was time to do it. The worst part of it is, I didn’t take my injectables as prescribed. And during that period, I was having relapse after relapse. And it wasn’t until 2008...when I finally ended up getting a new neurologist. She was the first person I wanted to open up to and be honest with. And it took a few years, but I developed a new attitude, a more positive attitude. And I knew a new treatment plan was the way the go. And I don’t just mean with medication. I mean the way I ate, exercising...that’s when my life started to change more for the positive. But just saying those three words, “I need help” can be such a big difference in your life if you’re open to it.

 

In late 2021...I ended up having a relapse on the medication I was on previously…and after an MRI had showed new lesions, my doctor said, “The efficacy of this…medication doesn’t seem to be working for you anymore. So it may be time for us to start looking at different treatment options.” Now, one still involved infusions. The other did as well, one with more frequency than the other. But I wanted more of what I still had...which was an oral treatment. So when I saw MAVENCLAD and I saw...the treatment regimen of 10 pills a year...for just two years, I got a little excited and I’m thinking this could really help me...focus on life and put MS in the background.

Before starting MAVENCLAD...my doctor talked to me about the potential serious side effects like cancer and birth defects. We also discussed monitoring before, during and after treatment. So I went ahead and decided to try. Yes, let’s try this treatment. I think...this is the one that’s going to fit into my lifestyle. And once I started the treatment and the side effects for me were mild. The treatment phase of this was so unintrusive in my life. Now, this is my experience. Yours may be different. I find that I’ve been able to focus now on more on the things that I used to enjoy doings.

Life changes, it grows, and sometimes, you have to adapt...but that doesn’t mean it’s over. Sure, you may have goals that you can’t reach the same way...that you had planned out...but there’s no reason that you can’t still reach that goal. You may just have to find a different direction or a new path to it.

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

 

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

Hi! My name is Vickie...and I’ve been living with multiple sclerosis since 2007. It has been quite a journey, but I’m hoping that I can share a bit of my story with you throughout this experience.

Now for the fun questions that I get asked a lot about, and I’m super happy to talk about. What it’s like to be a mom with MS. Now, this is a very interesting question because I find that as a mom...as a mom...as a mom with or without MS, it comes with its challenges. This year especially—my youngest just started kindergarten, so I went back to work. So, this mom is learning how to manage work-life balance: work a full-time job, and still get all the chores and errands that I did before as a stay-at-home mom done. It’s a challenge. And on top of it, I’m so tired. Fatigue is real, and it’s not tired like I need a nap. I’m just tired. I am a Type A personality through and through,..and I like to take control of all situations whenever I can, so, I took that as my challenge, to understand what MS meant to me. My husband jokes that I plan to plan and I sure do. I plan all my meals out. I do grocery pickup one day a week with all my things, and I really need to be that structured because not having to worry about dinner, or running to the grocery store, or running errands during the week is what works best for me. So through this lifestyle that’s given me a lot of curve balls and changes, its made me more empowered. Every day is a new day and every day is a new challenge. I hope that you don’t think that I’ve figured it out, because I surely haven’t. It’s a constantly moving, changing, and understanding thing, day by day, and I hope you’re a part of my journey as I hope to be a part of yours.

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

 

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

Hi, my name’s Vickie. I come to you from the sunshine state of Florida, but that’s not where my story began. I was diagnosed in 2007. I was living and working in the state of Connecticut, where I was born and raised. In Connecticut, I met my husband, who was in the military. From Connecticut, we traveled to Washington state and now are here in Florida. So, my journey has changed quite a bit over the years.

I feel that in life everybody’s going to have something. And for me, it just so happened that my something is multiple sclerosis. It’s taken many years for me to really grasp around what this disease is and what it is for me. And I think for me, the biggest thing I get out of having MS is talking to others, sharing stories, and understanding. I’ve become a more educated and empowered patient because of those that I’ve talked to.

It’s not a death sentence. And that’s what I thought it was at 23. I’m here more than 10 years later. I was able to date. I was able to find my husband and get married and have two kids and follow him with the military to all these different places.

You are not alone.

You are not on this journey by yourself. We are here with you, and there are many of us. And I hope that sharing a bit of myself will let someone know that they’re not alone and that they can still live their life.

Thanks for joining me today, sharing a little bit about my story. And I hope you come back and always know that you are not alone.

What is MAVENCLAD? MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS).

It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

 

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

Hola. Mi nombre es Maby, les mando saludos desde Las Vegas, Nevada. Quiero compartir mi experiencia viviendo con la esclerosis múltiple.

Yo recibí mi diagnóstico en el año 2003, ya hace unos diecinueve años. Y mi experiencia fue de recaídas una o dos veces al año, donde me llevó a usar diferentes medicamentos.

En el año 2019, me mandaron a hacer análisis de sangre y resultó que mis funciones hepáticas estaban un poco elevadas. Mi neurólogo me pidió que parara todo medicamento por un tiempo hasta que se resolvieran esos laboratorios. Y durante ese tiempo me pidió que me educara, que fuera a aprender de todos los medicamentos disponibles para cuando se resolviera todo eso que yo estaba padeciendo, pudiéramos volver a empezar un medicamento.

Y bueno, en consulta con mi neurólogo, platicamos sobre el medicamento MAVENCLAD. Con mi médico hablamos sobre el riesgo de desarrollar cáncer, defectos congénitos y otros posibles efectos secundarios. Y luego me mandó a hacer algunos análisis de laboratorio antes de empezar el medicamento.

Platiqué con mi neurólogo sobre la dosis y me explicó que está basada sobre el peso de uno...Mi primer mes iban a ser 5 pastillas, tomar por una semana, repetirse el segundo mes, 5 pastillas por una semana y luego no tener que tomar medicamentos por el resto del año. Después repetiríamos el mismo tratamiento el segundo año. En el transcurso del primer año y del segundo año también tuvimos que hacer análisis de sangre cada tres meses y a seis meses. Y hoy me gusta disfrutar. Pues a solas me gusta salir a mi patio, tomar un cafecito, ver las vistas que tengo de las montañas, también tengo una alberca y puedo salir a nadar, escuchar música y pues nomás es sentarme y tomar un relajado momento y dar gracias, verdad.

Anteriormente, tenía que viajar con bolsas de hielo, refrigerante, en una loncherita para mantener mi medicamento frío...Todo eso se facilitó con este medicamento de Mavenclad, y les puedo decir que, para mí en lo personal, fue un estrés menos que tenía. No me tenía que preocupar de llegar a casa equis
tiempo para tomarme mi inyección...Y ahora les puedo decir pues que viajo con facilidad. Me gusta ir al gimnasio, me gusta convivir con mi familia, salir a espectáculos... Es importante mantenernos haciendo cosas que nos gustan. Tengo pues más oportunidades sin tener que preocuparme sobre el medicamento como lo hacía antes. Les quería comentar que han sido mis experiencias con Mavenclad y las de ustedes pueden ser diferentes. Bueno, y les dejo con esto: no hay que rendirse nunca. Si una medicina no les está funcionando, no quiere decir que no hay otra que les pueda ayudar.


                        MAVENCLAD Información de seguridad importante

¿Qué es MAVENCLAD?
MAVENCLAD es un medicamento con receta que se usa para tratar las formas recurrentes de esclerosis múltiple (MS), para incluir la forma recurrente-en remisión y la forma secundaria progresiva de la enfermedad, en adultos. Por el perfil de seguridad, MAVENCLAD se usa por lo general con personas
que ya han tomado otro medicamento para MS que no podían tolerar o que no ha funcionado lo suficientemente bien.

MAVENCLAD no se recomienda para uso en personas con síndrome clínico aislado (CIS). No se sabe si MAVENCLAD es seguro y eficaz en menores de 18 años de edad y, por lo tanto, no se recomienda.


MAVENCLAD podría causar efectos secundarios graves, incluyendo:
    • Riesgo de cáncer (neoplasias malignas)
. Debe seguir las instrucciones del proveedor de salud    medica sobre hacerse pruebas de detección de cáncer.

    • MAVENCLAD podría causar defectos congénitos si se toma durante el embarazo. Las mujeres no deben estar embarazadas cuando comiencen el tratamiento con MAVENCLAD, ni embarazarse mientras estén tomando MAVENCLAD, y en un plazo de 6 meses despuésde la última dosis de cada tratamiento anual. Debe de parar el tratamiento con MAVENCLAD y comunicarse con su proveedor de salud médica de inmediato si se embaraza durante el tratamiento con MAVENCLAD.
    • Para las mujeres que pueden quedar embarazadas:
        o Su proveedor de salud médica debe pedirle una prueba de embarazo antes de que usted comience el primer y segundo tratamiento anual de MAVENCLAD para asegurarse de que no está embarazada
        o Use métodos eficaces de control de natalidad (anticonceptivos) los días en los que tome MAVENCLAD y durante al menos 6 meses después de la última dosis de cada tratamiento anual.
             Hable con su proveedor de salud médica si toma anticonceptivos orales (la píldora).
             Deberá usar un segundo método de control de natalidad los días en los que tome MAVENCLAD y durante al menos 4 semanas después de la última dosis de cada tratamiento anual.
        o Para los hombres cuyas parejas puedan quedar embarazadas:
             Use métodos eficaces de control de natalidad (anticonceptivos) los días en los que tome MAVENCLAD y durante al menos 6 meses después de la última dosis de cada tratamiento anual.

No tome MAVENCLAD si usted:
    • tiene cáncer (tumor maligno).
    • está embarazada, tiene planes de quedar embarazada, o es una mujer en edad fértil o es un hombre que puede embarazar a alguien, y no está usando ningún anticonceptivo.
    • está amamantando.
    • es positivo para el virus de inmunodeficiencia humana (VIH).
    • tiene infecciones activas, incluyendo tuberculosis (TB), hepatitis B o C.
    • tiene alergia a la cladribina (cladribine).

Antes de tomar MAVENCLAD, hable con su proveedor de salud médica sobre todas sus condiciones medicas, incluso si usted:
    • cree que tiene una infección.
    • ha tomado, toma o tiene pensado tomar medicamentos que afecten el sistema inmunológico o los glóbulos sanguíneos, u otros tratamientos para MS. Ciertos medicamentos pueden aumentar el riesgo de contraer una infección.
    • recibió recientemente alguna vacuna o tiene programado recibirla. No             deberá recibir vacunas con microbios vivos ni atenuados en un plazo de 4 a 6 semanas antes del tratamiento con MAVENCLAD, ni recibir esos tipos de vacunas mientras esté en tratamiento con MAVENCLAD, amenos que el proveedor de atención médica se lo haya pedido.
    • tiene insuficiencia cardíaca.
    • tiene o ha tenido cáncer.
    • tiene problemas con el hígado o los riñones.
    • está amamantando o piensa amamantar. No se sabe si MAVENCLAD se pasa a través de la leche materna. No amamante los días en los que tome MAVENCLAD y durante al menos 10 días después de la última dosis..

¿Cómo debo tomar MAVENCLAD?

    • MAVENCLAD se da como dos tratamientos anuales.

    • Cada tratamiento anual consta de 2 semanas de tratamiento (también llamadas ciclos) que se harán con un mes de diferencia.

    • Tome MAVENCLAD con agua y tráguelo sin masticarlo. MAVENCLAD se puede tomar con o sin comida.

    • Trague la píldora de MAVENCLAD de inmediato después de abrir el blíster.

    • Debe tener las manos secas cuando toque MAVENCLAD y lavárselas bien con agua después.

    • Limite el contacto con la piel. Evite tocarse la nariz, los ojos y otras partes del cuerpo. Si MAVENCLAD entra en contacto con la piel o cualquier superficie, lávela de inmediato con agua.

    • Tome MAVENCLAD con al menos 3 horas de diferencia entre otros medicamentos que se toman por vía oral durante los 4 a 5 días de la semana que dura el tratamiento con MAVENCLAD.

    • Si olvidó una dosis, tómela tan pronto como lo recuerde el mismo día. Si pasa todo un día sin que lo recuerde, toma la dosis omitida al día siguiente. No tome 2 dosis al mismo tiempo. En cambio, la semana de tratamiento se tardará más días.Su proveedor de salud médica seguirá dando seguimiento a su salud durante los 2 tratamientos anuales, y durante al menos 2 años más durante los que no es necesario que tome MAVENCLAD. No se sabe si MAVENCLAD es seguro y eficaz para personas que reinician el tratamiento con MAVENCLAD más de 2 años después de completar los 2 tratamientos anuales.


MAVENCLAD puede causar efectos secundarios graves. Si tiene alguno de estos síntomas, llame a su proveedor de atención médica de inmediato:
    • hemogramas bajos. Se han dado casos de hemogramas bajos y es posible que, durante el tratamiento con MAVENCLAD, aumente el riesgo de contraer infecciones. Es necesario que se haga análisis de sangre antes de comenzar el tratamiento con MAVENCLAD, durante el tratamiento, y después del tratamiento, según sea necesario.
    • infecciones graves como:
        o TB, hepatitis B o C y herpes (herpes zoster, culebrilla). Ha habido casos mortales de TB y hepatitis con cladribina durante estudios clínicos. Hable de inmediato con su proveedor de salud médica si tiene algún síntoma de estos problemas relacionados con infecciones o si alguno de los síntomas empeora, incluyendo: fiebre, dolor muscular, dolor de cabeza, malestar general, perdida de apetito, ardor, hormigueo, entumecimiento o picazón de la piel en el área afectada, manchas en la piel, sarpullido con ampollas o dolor intenso.
        o leucoencefalopatía multifocal progresiva (PML). La PML es una infección cerebral rara que generalmente causa la muerte o una discapacidad grave. Aunque la PML no se ha visto en pacientes con MS que toman MAVENCLAD, podría verse en personas con un sistema inmunológico débil. Hable de inmediato con su proveedor de salud médica si tiene nuevas señales o síntomas neurológicos, o las que tiene empeoran. Estas podrían incluir: debilidad
en un lado del cuerpo, pérdida de coordinación en los brazos y las piernas, disminución de la fuerza, problemas de equilibrio, cambios en la vista, cambios en el razonamiento o la memoria, desorientación o cambios en la personalidad.
    • problemas con el hígado. Deberá hacerse análisis de sangre para saber el estado del hígado antes de que comience a tomar MAVENCLAD. Síntomas de problemas con el higado podria incluir: náuseas, vómitos, dolor de estómago, cansancio, perdida de apetito, orina oscura o si la piel o el blanco de los ojos se vuelve amarillo.
• reacciones alérgicas (hipersensibilidad). Deberá dejar el tratamiento y buscar atención médica inmediata si tiene alguna señal o síntoma de una reacción alérgica. Los síntomas de una reacción alérgica podrían incluir: sarpullido, hinchazón o picazón de la cara, los labios, la lengua o la garganta, o dificultad para respirar.
 insuficiencia cardíaca. MAVENCLAD podría causar insuficiencia cardíaca, que significa que el corazón podría no bombear tan bien como debería. Llame a su proveedor de salud médica o vaya a la sala de emergencias más cercana para pedir atención médica de inmediato si tiene cualquier señal o síntoma como falta de aire, latidos rápidos o irregulares o hinchazón atípica en el cuerpo.

Los efectos secundarios mas comunes de MAVENCLAD incluyen: infección respiratoria de las vías superiores, dolor de cabeza y recuento bajo de glóbulos blancos.

Estos no son todos los efectos secundarios de MAVENCLAD. Llame a su médico para pedirle recomendaciones sobre los efectos secundarios. Puede reportar los efectos secundarios al FDA llamando al 1-800-FDA-1088.

Lea la Información para recetar/guía completa del medicamento, incluyendo los efectos secundarios graves, para obtener más información de seguridad importante.
EMD Serono es la compañía de salud médica de Merck KGaA, Darmstadt, Alemania en los EE. UU. y Canadá.
MAVENCLAD es una marca registrada de Merck KGaA, Darmstadt, Alemania o sus afiliadas. ©2023 Merck KGaA, Darmstadt, Alemania o sus afiliadas. Todos los derechos reservados. US-MAV-01758 11/22 Impreso en EE. UU.

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple

sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS).

MAVENCLAD may cause serious side effects. Treatment with MAVENCLAD may

increase your risk of developing cancer. You should follow healthcare provider instructions about screening for cancer. Because of the risk of birth defects, do not take MAVENCLAD if you are pregnant or of childbearing potential and not using effective birth control.

You’ve got this, girl. You woke up, you got out of bed, you can do it. Everything is gonna to be okay.

And that’s the pep talk I give myself every morning and throughout the day. It’s what helps keep me going. I look back on all those times I just wanted to throw in the towel. There were many hard days.

When I got my diagnosis of relapsing-remitting multiple sclerosis in my late twenties, there was an immense wave of fear that came over me.

I had recently given birth to my third child, and you know, I slowly started having symptoms: bladder incontinence, loss of strength in my limbs; I also had cognition problems and loss of peripheral vision. I didn’t think it was anything serious. I was a young mom, I was working in the real estate industry, and that’s a lot of pressure. It was really easy for me to push it aside.

There came a point that I was not able to ignore it anymore. One morning, I was out with my daughter. We were out back playing, and my knees started buckling. I couldn’t stand. I mentioned it to a friend, and she said, “You need to go to the doctor.” And I did.

He examined me and immediately sent me off for an MRI. I went back home, and, but as I arrived home, the doctor was calling me to go back into his office. So, I knew something was wrong.

When I got that immediate call—fear. Fear. I knew my husband wasn’t gonna be able to join me, because he couldn’t. So, I guess I’ve always talked to myself in the mirror, and I said, “Okay. You cry. Cry and put yourself together and get in that car and go.” And so I did.

Based on my MRI, my doctor believed that I had multiple sclerosis and he referred me out to a neurologist. Hearing you have multiple sclerosis, I was, I was—I guess kind of glad it wasn’t cancer. And then I didn’t know what it meant.

My neurologist later confirmed multiple sclerosis diagnosis with a spinal tap and my MRI. I started treatment right away. It’s been almost 20 years since I received my diagnosis, and I’ve been on several treatments.

During the initial, I want to say, maybe 10-15 years of my diagnosis, I was having a relapse almost every year. In 2019, my liver was not able to tolerate the medication that I was on, so my neurologist took me off of medication.

So, I started doing my own research, and I found out that MAVENCLAD® was an oral treatment. It was tablets. And that really interested me.

I talked to my neurologist that told me that the dosing schedule would be no more than ten treatment days a year for two years.

He told me about all the benefits and all the potential serious side effects, such as risk of cancer, low white blood cell counts, serious infections, and liver problems. I would be monitored before, during, and two years after treatment.

He wanted to make sure I was aware of the risk of birth defects if I were to get pregnant during treatment, and I should use effective birth control while taking MAVENCLAD and for at least 6 months after the last dose in year 1 and year 2. He said it would be okay to consider pregnancy after waiting at least six months after my last dose in the second year.

After careful consideration, I decided to give MAVENCLAD a try.

I called MS LifeLines® and I was happy to learn that I did qualify for their copay assistance program.

I was screened and tested before I started MAVENCLAD. My first course of treatment consisted of taking seven tablets over the course of five days. Then I repeated this one month later.

The dosing schedule in year two of treatment was the same. After my first two doses, I experienced some insomnia. But that eventually resolved.

So far, I have been doing well. My doctor is pleased with my labs results. I have not had any new lesions, and I have not relapsed.

I now can look back and just say, “Wow.” I can’t believe I’ve overcome those hurdles. My family is everything. I absolutely could not have done this without them.

A daily reminder for myself is just, be happy. Enjoy life. Keep on going. You’re doing good, baby girl. You’re doing good. Just keep going.

 

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple

sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS).

MAVENCLAD may cause serious side effects. Treatment with MAVENCLAD may

increase your risk of developing cancer. You should follow healthcare provider instructions about screening for cancer. Because of the risk of birth defects, do not take MAVENCLAD if you are pregnant or of childbearing potential and not using effective birth control.

My name is Ron. I’ve been married to my beautiful wife Marilyn for over 30 years. We have two grown sons, Ronald and Jaison.

Now, I’m retired. I used to do refrigeration, air conditioning, and heating, and I rose to the level of operations manager.

My job was really stressful, but to be honest with you, I really miss being in the heat of the action.

I was diagnosed with relapsing MS in 2009. I remember one day my right arm went limp, and at the same time, I couldn’t swallow, and so, I thought I was having a heart attack or a mini-stroke.

The doctors ran a series of tests over a 10-day period – a CT scan, a MRI, and at the end of that, I was called in and given the news that I had relapsing multiple sclerosis.

My initial response to the diagnosis was not good. My mom’s late cousin had been bedridden with MS for over 20 years, and so I felt like my life was over. I felt like I was headed for a wheelchair or an early death. So, it was just a real emotional rollercoaster for the first couple of years.

And then, my sister got diagnosed with relapsing multiple sclerosis, and so, when my sister got diagnosed, I was like you “You know what, I gotta pick myself up.” I wanted to be an encouragement to her.

I actually started to look outward instead of looking inward, and I realized that as devastating as the diagnosis was, it was also a relief because it answered why I had been having right side weakness and fatigue for over 20 years.

My journey to finding the right treatment was a bumpy road. I was on one treatment for a while, but I did not tolerate it well.

From there, my doctor and I discussed several treatment options, and we landed on one that required multiple injections a week. I spent years on that therapy, but I experienced unwelcome side effects that made it harder and harder to stay compliant.

I was to the point that I wanted to explore other options. I wanted to know what else was out there.

One day I did some research and read about MAVENCLAD. I asked my neurologist about it. He said it’s an oral treatment that I only have to take eight to ten days a year for two years.

For me, that meant I would take two pills a day for five days then do it again about a month later. Then, my MS treatment would be done for that year.

I was very intrigued with the dosing schedule. Number one, I couldn’t believe it, and then secondly, I felt like “Wow! This could work for me.” We went over the potential benefits and risks of MAVENCLAD.

He explained the possible serious side effects, the risk of cancer, low white blood cell counts, serious infections and liver problems. We also talked about how I would need to be monitored.

My doctor and I decided that MAVENCLAD was the right option for me.

Since starting MAVENCLAD, I’ve been very consistent. So far, I haven’t had any relapses. I still experience right side weakness and fatigue from time to time, and so I’ve

learned to not overdo it. I’m aware of how much I can do and when, and when it’s time to rest, I rest.

I have quarterly doctor visits, and he monitors my blood work, and we discuss any symptoms I may or may not be having or if I have any new symptoms.

I’m so grateful for MAVENCLAD, and I’m so glad that this therapy does not have to be taken every day. I would say on my MS journey, I’m at a very good place. I’m moving towards my goal. I want my life to be the mirror that reflects the image of hope.

I’m involved in a support group that meets monthly. It’s important to me that I can make an impact on someone else’s life.

Today, I try not to make my MS bigger than it is. It’s one part of my life. It doesn’t have to define me.

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

 

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS).

MAVENCLAD may cause serious side effects. Treatment with MAVENCLAD may increase your risk of developing cancer. You should follow healthcare provider instructions about screening for cancer. Because of the risk of birth defects, do not take MAVENCLAD if you are pregnant or of childbearing potential and not using effective birth control.

Hi, my name is Alexandra, and I live in upstate New York. I am a busy wife, mom and middle school teacher. I have identical twin boys, and a hundred-pound lab named Gus. Gus is very much like a third son, because I’m his mama, and he needs me, and I very much need him also.

I was diagnosed with relapsing MS in December 2015. I remember waking up one morning and not feeling the floor beneath my feet. I tried really hard to take a couple of steps and stumbled pretty fast. I noticed that the entire right side of my body was totally numb.

I contacted my general practitioner right away. He wanted to run an MRI to rule some things out.

I’ll never forget when my doctor called and said, “We have evidence of white lesions on your brain, and it all leads to multiple sclerosis.” It was like the world went away for a second, and the words were just echoing in my head. I gave the phone to my husband, and I turned to my mom, and I just collapsed in her arms.

I went to see a neurologist as soon as I could. We went right into the different treatments that were available for me, different options, how each of those options would impact my life. We tried two different treatments. We were hopeful about both, but I developed lesions while on the first treatment and had a severe allergic reaction while on the second treatment.

It was a scary time of a lot of unknowns. You know, when you try two different treatments, you start developing this thought process of, “Is not any type of medication ever going to work for me?” I didn’t know how many options I had left.

As luck would have it, I had a neurologist appointment a month after MAVENCLAD had been approved. My doctor wanted to talk with me about it.

He told me that MAVENCLAD is a short course oral treatment option with no more than 10 treatment days a year for two years.

In the first year for me, it would mean taking two tablets on one day, then one tablet for four days – then doing the same thing a month later.

I felt the dosing schedule was something I’d be able to handle. He went over serious side effects, like risk of cancer, low white blood cell counts, serious infections, and liver problems. He also told me about all the monitoring requirements.

My doctor made sure I was aware of the risk of birth defects if I were to get pregnant during treatment. He said it’d be okay to consider pregnancy after waiting at least six months after my last dose.

My doctor felt confident that MAVENCLAD would be a good fit for me. That’s what really gave me confidence in making the switch.

Before we made the final decision to go ahead with MAVENCLAD, my doctor provided me with the patient information kit that I could look through. I made sure to talk about it with my husband. I talked about it with my parents as well. I was excited. I was hopeful that it could help slow the progression of my MS.

A nurse from MS Lifelines® reached out to me, and she offered me an in-home visit to go over details of the treatment. It felt like I had someone that was there dedicated to me to help me navigate this journey.

I feel really good about being able to fit MAVENCLAD dosing into my routine. I’ve been keeping up with all my monitoring appointments, and, so far, my doctor and I are happy with the results we’re seeing on MAVENCLAD.

Of course, everyone’s experience is different. For me, MAVENCLAD is helping me manage my MS.

I feel like now my focus has totally shifted. I can now worry less about the day-to-day of my MS and focus more on how I can be a better mom, how I can be a better wife, how I can be a better teacher. I’m planning more for the future.

Ironically, MS has taught me to always find the silver lining in things. Having woken up one day and not felt the floor beneath my feet, it makes you very grateful for those little things, such as being able to feel that floor.

I have so many blessings in my life. I have my husband. I have my boys. I have Gus. And that’s what helps me go forward.

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

 

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

My neurologist and I decided to switch from my previous injectable treatment when he found new lesions on my MRI. The shots were painful and didn’t work with my travel schedule. An oral treatment seems to be right for me.

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

 

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS).

MAVENCLAD may cause serious side effects. Treatment with MAVENCLAD may increase your risk of developing cancer. You should follow healthcare provider instructions about screening for cancer. Because of the risk of birth defects, do not take MAVENCLAD if you are pregnant or of childbearing potential and not using effective birth control.

When I’m working out I really try to stay in the moment and focused on what I’m doing rather than what has to be done. When I do try to clear my mind and just try to focus on my breath, it’s a tremendous gift to yourself. I just try to make it a priority, first thing—knock it out. Because as soon as I’m done, I have to switch into “mom mode.”

Juggling my kids and all of their activities, things that they’re excited about and interested in has really kept me busy. I consider myself kind of a go-getter, and always stayed really busy in the community. I served on a community board, I volunteered with my church…So, when I was diagnosed in August of 2015, that came to a halt.

It was the summer of 2015, and my family and I thought it would be really fun to get our extended family to all rent a house together on a beach in Florida.

Then one morning on this vacation, I woke up, and I felt a little hazy in my left eye. Over time, the blurriness didn’t really go away, and I was feeling a little dizzy. So, when we got back into town, that’s when I went to the urgent care.

The doctor was like, I think you’ve had a stroke. So, my husband, Adam, took me to the ER right away.

I had the MRI, and the ER doctor said, you have what’s called optic neuritis. So, I was put on steroids and then my vision eventually started to return. And from that point on, there were many doctors’ visits that followed.

Eventually, I met with the neurologist, and they called me into his office and that’s when I got the news.

It was my spinal epidural test that showed I had multiple sclerosis.

The first thing that I thought of was, you know, people who are in wheelchairs or using walkers. I was really caught off guard. I called Adam right away, and he came, and it was really emotional.

Telling my kids—we told them separately. We did not tell all the kids together, and I think a lot of that had to do with their ages. It was hard for me, because I knew what it meant for our family and how it was gonna change the direction of our family.

I started treatment, and I took some time to kind of reprioritize my life at that time and really decide what was important. I was on treatment for about five years when my doctor came to me and said, “Due to some side effects, we need to—we need to switch you to another treatment.

And that—it was at that point that my doctor introduced me to MAVENCLAD. He said that MAVENCLAD is a short-course oral treatment option with no more than ten treatment days a year, for two years. My healthcare provider said I would be monitored before, during, and two years after my MAVENCLAD treatment.

We talked about the benefits and the risks including the possible serious side effects such as the risk of cancer, low white blood cell counts, serious infections and liver problems.

My doctor also told me that there was a risk of birth defects if I were to get pregnant while on treatment. He said I should use effective birth control while taking MAVENCLAD and for at least six months after my last dose of year one and year two. He also told me it was okay to consider pregnancy six months after my last dose of year two.

I had done my research on MAVENCLAD, and I really liked the dosing schedule. I felt good about it, so I decided to give it a try.

I’ve been doing well since taking MAVENCLAD and I am always sure to keep up with all of my monitoring appointments. My neurologist is pleased with the results, and the treatment seems to be working for me. This is just my experience. Everyone is different.

I have really appreciated MS Lifelines. MS Lifelines sends a nurse out to your house to walk you through everything and answer all of your questions, and she was fantastic.

Health and wellness has really become a top priority. Everything from what I eat to exercise to managing my stress level… One of the toughest things about MS is you just don’t always know what today is going to bring.

I’ve definitely had some rocky times. I think it took me a while to kind of find a groove and to realize what were triggers and what weren’t. When I’m having a tough day, I just can’t push.

MS has taught me that I can’t be the perfect mom and that sometimes I do have to give a little and let people help.

My family has made a huge impact on making this manageable. They help a lot with just the chores around the house, yard work, mowing the grass—all of those things that I think, you know, make the household run.

MS has taught me a lot of gratitude. Just to be thankful for what I do have. You know never know what tomorrow will bring, so you should be grateful for what you have today.

MAVENCLAD (cladribine) tablets Important Safety Information

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile,  MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.



woman

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Do you have a passion for supporting and encouraging others living with MS? Would you like to be a MAVENCLAD Ambassador*?

To find out how, call 1-888-910-0219

 

*You must be 18 years or older and taking MAVENCLAD.


US-MAV-02156 Last Updated 10/2023

WHAT IS MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS).

It is not known if MAVENCLAD is safe and effective in children under 18 years of age, and is therefore not recommended.

IMPORTANT SAFETY INFORMATION

MAVENCLAD may cause serious side effects, including:

  • Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
  • MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
    • For females who are able to become pregnant:
      • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
      • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
        • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
        • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.
    • For males with female partners who are able to become pregnant:
      • Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

  • have cancer (malignancy).
  • are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
  • are breastfeeding.
  • are human immunodeficiency virus (HIV) positive.
  • have active infections, including tuberculosis (TB), hepatitis B or C.
  • are allergic to cladribine.

Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:

  • think you have an infection.
  • have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
  • have heart failure.
  • have or have had cancer.
  • have liver or kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

  • MAVENCLAD is given as two yearly treatment courses.
  • Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
  • Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
  • Swallow MAVENCLAD right away after opening the blister pack.
  • Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
  • Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
  • Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
  • If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

  • low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
  • serious infections such as:
    • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
    • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
  • liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
  • allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
  • heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.