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.

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.ant Safety Information.