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.