Starting in my early 20s, I experienced bouts of intense fatigue. It got so bad that, at the age of 22, I fell asleep at the wheel of my pickup and was hit by an 18-wheeler. Both trucks exploded into flames. By what I call divine intervention, I survived that accident without spending a night in the hospital.
During this time, I worked a high-stress job as an HVAC technician. I loved the action but continuously suffered from extreme fatigue and weakness on the right side of my body.
I advanced in my career, but my symptoms persisted with no clarity as to the reason behind them. Many doctor visits over the years failed to elucidate the cause of my symptoms. I didn’t think much of it until 2008 brought more than just fatigue.
My path to diagnosis
After being promoted to operations manager, my work-related stress levels increased. Midway through 2008, I began tripping over unseen obstacles. In December, I reached a breaking point — my right arm went limp. I feared I was having a heart attack or a mini-stroke. After ruling out those causes, my doctor advised me to see a neurologist, who conducted a series of tests.
Two weeks later, everything changed: I received the news that I had relapsing multiple sclerosis (RMS). I freaked out. I thought MS was a death sentence. My neurologist advised me to start therapy immediately. Though overcome with fear, I complied.
Finding the right treatment for me
My treatment journey was far from easy. I was on an injectable therapy for several years that brought side effects and the lack of motivation to stay compliant. Traveling with the treatment became burdensome as well.
I was determined to explore alternative treatment options. After frank discussions with my neurologist, she made me aware of an oral treatment: MAVENCLAD® (cladribine) tablets, for oral use. My doctor explained the potential benefits of MAVENCLAD as well as the risk of serious side effects, including the risk of cancer, birth defects, low white blood cell counts, serious infections, and liver problems.
The convenient, short-course dosing schedule of MAVENCLAD particularly interested me. For me, I would only have to take two pills a day for five days, do it again a month later, and my MS treatment would be done for that year. After repeating this process a year later, that would be it!
After she explained that screening and monitoring would be required before, during, and after treatment, we agreed that MAVENCLAD was the best fit, and I scheduled my first treatment in 2019.
Redefining my narrative
My experience with MAVENCLAD has been positive, affording me the pleasure of waking up and focusing on breakfast rather than having to remember to take a shot. The convenience of the short-course dosing means I no longer have to schedule my life around my treatment.
Thanks to MAVENCLAD, I have redefined the narrative of my life beyond RMS. I’ve finished my treatment courses, haven’t had any relapses, and am able to enjoy traveling, as well as time with loved ones. Today, I try not to make my MS bigger than it is. It’s one part of my life — but with MAVENCLAD, it doesn’t define me.
BRIEF SUMMARY OF IMPORTANT INFORMATION ABOUT MAVENCLAD® (cladribine) tablets, for oral use
Read this information carefully before using MAVENCLAD. As this is not all the information about this prescription medicine, talk to your doctor and visit www.mavenclad.com to see the FDA approved labeling and patient Medication Guide.
What is the most important information I should know about MAVENCLAD?
MAVENCLAD can cause serious side effects, including:
- Risk of cancer (malignancies). Treatment with MAVENCLAD may increase your risk of developing cancer. Talk to your healthcare provider about your risk of developing cancer if you receive MAVENCLAD. You should follow your 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. Stop your treatment with MAVENCLAD and call your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
- For women who are able to become pregnant:
- Your healthcare provider should order a pregnancy test for you before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant. Your healthcare provider will decide when to do the test.
- Women who can become pregnant as well as men with female partners who can become pregnant, should 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.
- Ask your healthcare provider which contraceptive method is right for you.
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.
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. See “What is the most important information I should know about MAVENCLAD?”
- are human immunodeficiency virus (HIV) positive.
- have active infections, including tuberculosis (TB), hepatitis B or C.
- are allergic to cladribine.
- are breastfeeding. See “Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:”
Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:
- think you have an infection.
- have heart failure.
- have liver or kidney problems.
- have taken, take, or plan to take medicines that affect your immune system or your 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 your treatment with MAVENCLAD. You should not receive these types of vaccines during your treatment with MAVENCLAD and until your healthcare provider tells you that your immune system is no longer weakened.
- have or have had cancer.
- 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. See “Do not take MAVENCLAD if you:”
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take MAVENCLAD?
- MAVENCLAD is given as two yearly treatment courses; each course consisting of approximately 2 treatment weeks (also called 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 oral medicines.
- Wash your hands after handling MAVENCLAD. Limit contact with your skin (especially on your face). 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.
- 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.
What are the possible side effects of MAVENCLAD?
MAVENCLAD can cause serious side effects, including:
- See “What is the most important information I should know about MAVENCLAD?”
- low blood cell counts. Low blood cell counts have happened and can increase your risk of infections during your treatment with MAVENCLAD. Your healthcare provider will do blood tests before, during and after your treatment with MAVENCLAD, as needed.
- serious infections such as:
- life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi
- 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, and 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/legs
- decreased strength
- problems with balance
- changes in your vision
- changes in your thinking or memory
- confusion
- changes in your personality
- liver problems. MAVENCLAD may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking MAVENCLAD. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
- nausea
- vomiting
- stomach pain
- tiredness
- loss of appetite
- your skin or the whites of your eyes turn yellow
- dark urine
- allergic reactions (hypersensitivities). MAVENCLAD can cause serious allergic reactions. Stop your treatment with MAVENCLAD and go to the closest emergency room for medical help right away if you have any signs or symptoms of allergic reactions. 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. Your healthcare provider may delay or completely stop treatment with MAVENCLAD if you have severe side effects.
The most common side effects of MAVENCLAD include:
- upper respiratory infection
- headache
- 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 suspected adverse reactions to EMD Serono at
1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Distributed by: EMD Serono, Inc., Rockland, MA 02370
EMD Serono is the healthcare business of Merck KGaA, Darmstadt, Germany in the US and Canada.
MAVENCLAD is a registered trademark of Merck KGaA, Darmstadt, Germany or its affiliates.
For more information, call toll-free 1-877-447-3243 or go to www.mavenclad.com
©2024 Merck KGaA, Darmstadt, Germany or its affiliates. All Rights Reserved.
US-MAV-02387
Printed in USA 04/2024