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

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.


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.

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.

 

Please see important safety information at the end of this video and full prescribing information, medication guide, including serious side-effects.

 

I realized during gym class that something was really wrong when I felt some numbness in my arm. I wasn't able to do all the things that my friends were doing. I wasn't really able to play sports just because I'm feeling really weak, to the point where it looked like I wasn't even trying, even though I was trying my hardest.

My name is Sagal, and I live in Milwaukee, Wisconsin. I am 25 years old, and I am a student studying urban planning. I also work at a civil engineering firm. Some of the first symptoms were headaches and fatigue and having some numbness in my arm and in my leg. I would go to doctors, and they would just say maybe it has something to do like your period. It could be depression and it was just very frustrating because I don't really feel depressed, I just feel physical symptoms that are really holding me back.

I woke up one morning and I had to go to work. I had a really bad headache; I just took my medicine, and I went off to work and when I got to work it got much worse. The next morning, I had to end up going to the ER. The doctor was pretty dismissive. My dad is a physician and works at that hospital. He just went off and found another doctor to take me in and that doctor did a lot of tests, a lot of blood work, asked me if I had travelled anywhere, if I ate anything, CT scan, MRI, they did a spinal tap which confirmed everything, and they had neurologist come and the neurologist told me that I have MS. I felt on one hand relieved that I was not crazy, and I wasn't being too sensitive. I also felt a lot of dread, like I don't know what MS is, I don't know what's going to happen. I just felt like my life is over, like I don't how am I going to go to college, how I'm going to get married, how I'm going to have kids, how I'm just going to do regular things that I want to do.

I limited my stress and try to kind of give myself a schedule where I wasn't kind of just going to school and to work, doing all these activities and also exercise just to kind of maintain what strength I do have. Like, if I know, I have guests coming over to my house and I'm preparing everything and cleaning, cooking, I know the next day I'm going to have to take a break. My response from my friends and family was pretty good. I mean they were very supportive, and they were, of course, very scared, and worried.

My name is Bhupendra Khatri. I'm a neurologist in Milwaukee at the Center for Neurological Disorders. I specialize in multiple sclerosis. I put Sagal on an oral treatment option that she had to take every day and she became well enough to attend college on a limited basis and was able to work part-time.

He had been seeing me regularly throughout the years and during that time my symptoms had gotten worse. I was experiencing more headaches, more fatigue, more numbness, and tingling, it just was a lot. It had gone all the way up. I didn't even feel like myself and when I went to Doctor Khatri for my regular checkup, he had noticed changes in my test.

A new MRI confirmed some progression of the disease and she had to put her college studies and work on pause. I told her about MAVENCLAD cladribine tablets, which had come on the market in 2019. I had been following the development of MAVENCLAD for years. I felt that Sagal was an excellent candidate for this short-course oral therapy. MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis. 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, also known as CIS.

The process that Doctor Khatri kind of put me through, he just asked me some questions on you know, how I was feeling and things like that and going over MAVENCLAD and the risks and the benefits and kind of how the medication works.

At the same time, I reminded them that, look on one hand, we need to look at what are the risks of not treating MS. And the risk of not treating MS with an efficacious drug is that the disease will progress. I made sure that Sagal and her family were aware of potential side-effects. I explained that there is a cancer risk associated with the medication and she needed to follow screening guidelines. I also noted that there is a risk of birth defects for pregnant women, and that men and women of childbearing age should use effective birth control during treatment and for at least six months after the last dose of each treatment course. The most common side-effects of MAVENCLAD include upper respiratory infection, headache and low white blood cell counts.

MAVENCLAD is the only short-course oral therapy that requires a maximum of 10 treatment days a year over two years. Patients take one to two tablets for up to five days per month for two consecutive months during the first year and then repeat the course at the beginning of the second year. Patients will continue to be monitored throughout the course of MAVENCLAD treatment, and at least for another two years in which you do not need to take MAVENCLAD.

During the 96-week clinical trial for MAVENCLAD, patients who took the medication experienced a 58% reduction in relapse rates per year compared to those who took a placebo. MAVENCLAD is believed to work by reducing the number of T and B cells in the body, so there are fewer of them to attack the nerves. Low blood cell counts can increase your risk of infections during your treatment with MAVENCLAD. Once treatment is finished for the year, the immune system will begin to produce new T and B cells. It may take several months or more for the recovery of the T and B cells, but some patients may not go back to pre-treatment levels.

Sagal! How are you doing? You're looking great. How do you feel? We discussed about what this drug would mean for Sagal, and I think she liked the idea that one, this is a drug which she does not have to take on a daily basis, like what she was doing before, and also the efficacy of the drug.

The dosing with MAVENCLAD is a lot better for me, because I'm not having to worry about going in for an injection and I like it a lot more.

I think right now, Sagal is doing very well. She has a very positive outlook on life. She is working out; she is attending college. She can accomplish her goals that she has set out to.

I would tell people that were recently diagnosed with MS, that you know life continues and although it seems like you know, this is something that is a huge kind of obstacle or block, that there are a lot of great doctors and nurses and other healthcare professionals out there that are willing to help you.

MAVNENCLAD 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.

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.

I brought up the idea of taking MAVENCLAD to my neurologist after I got macular edema from taking another treatment. The thought of taking medication only 10 times a year for 2 years vs a daily treatment was a win, win in my mind. I am a fanatic about keeping my medical tests like blood work, screenings up to date so that when it was time to start MAVENCLAD, I was ready.

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.


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 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

SHARE YOUR STORY

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.


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.