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’velearned 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.

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.