My name is Suzy; I live in South Carolina. I started MAVENCLAD in 2021 and finished the second course in 2022. Before I was diagnosed with relapsing MS, I lived a very active lifestyle, and for most of this earlier experience, I did have MS symptoms like numbness and tingling, but they were often confused with my athletic injuries. So, once I was officially diagnosed, my general neurologist did prescribe one of the earlier oral MS therapies. I started taking that while I was waiting to get approval for an infusion therapy. So, eventually, the infusion therapy was approved, so I went on that. But as I stayed on that therapy for about two and a half years, I felt like…it just felt like my MS was not in control, and I didn’t have anybody really monitoring that. So, I started searching outside of my area to find an MS specialist who was willing to really look at my MS and be sort of an advocate for my MS disease. I did find a neurologist and she seemed to take my MS seriously, seemed to take my age, took my lifestyle, everything else, and we began talking about a plan. Since my neurologist knew that I was concerned about my immune system being continuously weakened, she explained that MAVENCLAD was an option, and rather than continuously suppressing my immune system, it's thought to work by depleting my lymphocytes, and then allowing them to recover over several months. After my immune system begins to recover, hopefully without the cells that play a role in MS, it can fight infections and begin functioning normally again, which is what I was certainly searching for. Certainly, as I am aging, I was concerned about staying on any MS therapy, and certainly I was concerned about my immune system being depleted further. She did explain that MAVENCLAD is an oral tablet, and I was interested in the convenient dosing schedule. My doctor talked to me about the possible serious side effects including risk of cancer, birth defects, low white blood cell counts, serious infections, and liver problems. I do have a history of skin cancers, basal cell carcinomas. So, before I started MAVENCLAD, my neurologist and I did have a discussion about that, and I had talked extensively with my dermatologist as well. She also told me I’d be monitored before, during, and after treatment. So, at that point we decided to give MAVENCLAD a try. I guess one of the huge advantages is I am not going for infusion treatments any longer. I don’t have to worry about premedicating beforehand. Since completing MAVENCLAD, I feel like my MS is much more stable. I haven’t had any relapses. I feel like my mobility continues to improve, and I hope to continue along that trajectory. And now this is my experience and yours may be different. Since I’ve been diagnosed, I have had to curtail some of my activities, and I have had to slow down, but I’ve learned how to modify some of the exercise that I do, and figured out no pain, no gain is not necessarily my motto so…I think one of the other areas that’s really important is to connect with others. In my area, there is not a lot of MS support, so I’ve learned to seek out connection online. I feel like I ignored my own symptoms for so long and realized that that is not necessarily the way to go. So, in talking with others, I encourage them to advocate for themselves, to pay attention to their own bodies and work at getting that earlier diagnosis. And so now I have grandchildren that I’m able to watch and I love at least being able to get out and be with them. And so, I may not be running marathons with them, but I can be cheering them across the finish line.

MAVENCLAD (cladribine) tablets

Indication and 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. Women 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.

o    For women 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.

o     Ask your healthcare provider which contraceptive method is right for you. Women and men being treated with MAVENCLAD should use effective birth control (contraception) on the days on which they 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, consisting of 2 treatment weeks (cycles) about a month apart.

·       Handle MAVENCLAD with dry hands and take immediately after opening the blister pack. Take with water and do not chew the tablet. MAVENCLAD can be taken with or without food and should be taken at least 3 hours apart from other medicines.

·       Wash your hands after handling MAVENCLAD. Limit contact with your skin (especially on your face). Wash skin and surfaces with water if contact occurs.

·       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.

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:

o     life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi.

o     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.

o    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. 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. Your doctor will perform blood tests to check your liver during treatment.

·       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 heartbeat, 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. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at: 1-800-283- 8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide, including serious side effects.

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

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

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

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

MAVENCLAD (cladribine) tablets

Indication and 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. Women 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.

o    For women 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.

o     Ask your healthcare provider which contraceptive method is right for you. Women and men being treated with MAVENCLAD should use effective birth control (contraception) on the days on which they 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, consisting of 2 treatment weeks (cycles) about a month apart.

·       Handle MAVENCLAD with dry hands and take immediately after opening the blister pack. Take with water and do not chew the tablet. MAVENCLAD can be taken with or without food and should be taken at least 3 hours apart from other medicines.

·       Wash your hands after handling MAVENCLAD. Limit contact with your skin (especially on your face). Wash skin and surfaces with water if contact occurs.

·       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.

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:

o     life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi.

o     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.

o    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. 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. Your doctor will perform blood tests to check your liver during treatment.

·       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 heartbeat, 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. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at: 1-800-283- 8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide, including serious side effects.

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

Before I was diagnosed with relapsing-remitting multiple sclerosis, I was heavily involved in martial arts. I really thought it was going to be my future. It wasn’t until late 2000 when I started to feel numbness and tingling on one side of my body, I was having trouble walking. I would drag half my body behind me…my speech had become more and more distorted, and my ability to focus and problem solve diminished. I had the kind of job where you really need to be focused. And it finally took someone that I was working with to say, “What is wrong with you?

Something’s wrong with you, man.” That’s when I was diagnosed with having a stroke. I had a lot of hope because I was young and I was strong, and I feel like I could really recover from this and continue my life plan. This didn’t have to get in my way. Life began to go on. Being treated still as a stroke patient that I got a new family doctor.

And once she took a look at my history, she just said, “Well, I think the stroke might not be the best diagnosis for you. I want to check and see if maybe multiple sclerosis may be playing a part in it. So she decided to send me to have an MRI and a spinal tap. When I was notified that the doctor wanted to see me again the next day, and just based on the tone in her voice, I kind of figured that my test came back positive for MS.

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

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

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

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

MAVENCLAD (cladribine) tablets

Indication and 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. Women 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.

o    For women 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.

o     Ask your healthcare provider which contraceptive method is right for you. Women and men being treated with MAVENCLAD should use effective birth control (contraception) on the days on which they 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, consisting of 2 treatment weeks (cycles) about a month apart.

·       Handle MAVENCLAD with dry hands and take immediately after opening the blister pack. Take with water and do not chew the tablet. MAVENCLAD can be taken with or without food and should be taken at least 3 hours apart from other medicines.

·       Wash your hands after handling MAVENCLAD. Limit contact with your skin (especially on your face). Wash skin and surfaces with water if contact occurs.

·       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.

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:

o     life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi.

o     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.

o    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. 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. Your doctor will perform blood tests to check your liver during treatment.

·       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 heartbeat, 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. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at: 1-800-283- 8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide, including serious side effects.

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.

MAVENCLAD (cladribine) tablets

Indication and 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. Women 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.

o    For women 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.

o     Ask your healthcare provider which contraceptive method is right for you. Women and men being treated with MAVENCLAD should use effective birth control (contraception) on the days on which they 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, consisting of 2 treatment weeks (cycles) about a month apart.

·       Handle MAVENCLAD with dry hands and take immediately after opening the blister pack. Take with water and do not chew the tablet. MAVENCLAD can be taken with or without food and should be taken at least 3 hours apart from other medicines.

·       Wash your hands after handling MAVENCLAD. Limit contact with your skin (especially on your face). Wash skin and surfaces with water if contact occurs.

·       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.

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:

o     life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi.

o     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.

o    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. 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. Your doctor will perform blood tests to check your liver during treatment.

·       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 heartbeat, 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. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at: 1-800-283- 8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Medication Guide, including serious side effects.