Mavenclad (cladribine) is a medicine used to treat relapsing forms of multiple sclerosis (MS) including relapsing-remitting MS and active secondary progressive MS. Relapsing forms of MS have temporary worsening of symptoms followed by periods of improvement.
Mavenclad is an oral tablet that is taken for two years. Mavenclad is used in people who have tried other MS medicines that did not work well enough or that they could not tolerate.
How Does Mavenclad Work for Multiple Sclerosis?
Mavenclad is a medicine that targets parts of your immune system known as B cells and T cells. These B and T cells are important in relapsing MS because they attack the protective covering of nerves, known as myelin, in your central nervous system. Mavenclad can help prevent MS relapses and progression of MS by stopping the B and T cells from attacking myelin.
What Should I Do Before Starting Treatment?
Mavenclad may increase your risk of developing cancer. Talk to your health care provider about your risks and follow your health care provider’s instructions about cancer screening.
Do not take Mavenclad if you are pregnant, as it can cause harm to a fetus. Talk to your health care provider if you are pregnant, planning to get pregnant, or become pregnant while using Mavenclad or within six months after the last dose of each yearly treatment course. You and your partner should use effective birth control while taking Mavenclad and for at least six months after your last dose.
Mavenclad affects the immune system and may increase your risk of infections. Do not take Mavenclad if you have an active infection, including tuberculosis (TB), hepatitis B or C, shingles (herpes zoster), or if you have HIV.
Your health care provider will review your vaccination record and recommend any vaccines you may need before starting Mavenclad. Live vaccines should not be given within four to six weeks before you start Mavenclad therapy. Examples of live vaccines include measles, mumps, rubella (MMR), and chickenpox. You should not receive these vaccines during your treatment with Mavenclad and until your health care provider tells you that your immune system is no longer weakened.
How Do I Use Mavenclad?
Mavenclad is a tablet that is taken by mouth as a two-year treatment course. Each course has two treatment weeks (cycles) that are about a month apart. Each cycle is four or five days. Your health care provider will tell you when to start your treatment weeks and how many tablets you need, depending on your weight. Take Mavenclad exactly as your health care provider tells you. Do not change your dose or stop taking Mavenclad unless your health care provider tells you to.
Take Mavenclad with water and swallow it whole without chewing. Swallow Mavenclad right away after removing it from the blister pack. It can be taken with or without food. Make sure your hands are dry when you handle the tablets, limit contact with your skin, and wash your hands well afterward. Take Mavenclad at least three hours apart from other medicines taken by mouth during the four- to five-day treatment week.
How Was Mavenclad Studied?
For MS, a study known as CLARITY was completed to see if Mavenclad was better than a placebo pill, which contained no medicine, at reducing the rate of relapse after 96 weeks (about two years). An extension of this study was done to see if the benefits lasted up to four years. The study included 1,326 people between 18 and 65 years old with relapsing-remitting MS who had experienced at least one relapse in the past 12 months and had brain lesions on magnetic resonance imaging (MRI) scans. A score of 0 to 5.5 on the Expanded Disability Status Scale (EDSS) was also required. The EDSS is a tool for measuring and monitoring changes in disability in people with MS. The score ranges from 0 to 10, with higher scores indicating more disability.
In the study, 68% of people were female, 98% were White, 0.5% were Black, and about 1.4% were listed as other. About 30% of people had already taken a disease-modifying medicine for MS, and the average disease duration from first onset was about nine years.
In the CLARITY study, people were randomly selected to receive a total dose of Mavenclad of 3.5 milligrams per kilogram of body weight, 5.25 milligrams per kilogram of body weight, or a matching placebo over the 96-week study period in two treatment courses.
The effectiveness of Mavenclad was measured by the annualized relapse rate (ARR), which is the average number of relapses per year. A lower ARR means there were fewer relapses per year. Mavenclad reduced the risk of relapse more than placebo after nearly two years of follow-up. The number of people who stayed relapse-free at two years was higher with Mavenclad, and the time to first relapse was longer compared to placebo. There were also fewer brain lesions seen on MRIs in people treated with Mavenclad than those treated with the placebo. The higher dose of 5.25 milligrams per kilogram of body weight of Mavenclad did not work better than the 3.5 milligram per kilogram of body weight dose and was associated with more lymphocytopenia (low counts of lymphocytes, a type of white blood cell that are a part of your immune system).
Mavenclad 3.5 mg per kilogram of body weight | Placebo | |
ARR | 0.14 | 0.33 |
Average number of MRI lesions | 0 0 | 0.33 (T1) 0.67 (T2) |
An extension of the CLARITY study showed that EDSS scores were stable for up to five years in over 50% of people treated with Mavenclad.
Your results may differ from what was seen in clinical studies.
How Long Does It Take to Work?
If Mavenclad is working, your symptoms will start to improve over the first few months. Most people see less MS relapses during the two years of taking the medicine.
Do not stop using this or any other medicines for MS without talking to your health care provider first, even if your symptoms have gotten better. Your symptoms may get worse again if you stop or change any of your medicines.
Tell your health care provider if your symptoms do not seem to be improving after about three months of using Mavenclad. Your health care provider may discuss other options for treating this condition. Your health care provider will continue to monitor your health during the treatment courses and for at least two years after you stop taking Mavenclad.
What Are the Side Effects of Mavenclad, and How Can I Manage Them?
The most common side effects seen with Mavenclad are infection, headache, and low lymphocyte levels.
People who take Mavenclad are more likely to have infections, especially an infection of the airways. These include infections in the nose or throat, a sore throat, or common cold symptoms. The best way to prevent infection is to reduce your exposure to germs by washing your hands and avoiding people who are sick. Tell your health care provider if you have a fever or other signs of infection such as aching, painful muscles, headache, or feeling unwell or losing your appetite while on a course of treatment.
Keep all appointments with your health care provider and lab. You will need a blood test to check your blood cell counts before you start each treatment course, two months after, and six months after each course. Your health care provider will also order blood tests to check your liver function before you start Mavenclad and before each course and cycle.
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that may cause death or severe disability. It has not been seen in people with MS taking Mavenclad, but it may happen in people with weakened immune systems. Tell your health care provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, such as:
- Weakness on one side of your body
- Loss of coordination in your arms and legs
- Decreased strength
- Problems with balance
- Changes in vision
- Changes in thinking or memory
- Confusion
- Changes in your personality
These are not all the possible side effects. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Mavenclad, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
Is There Any Cost Assistance Available?
There is a cost savings and support program, MS LifeLines, that may help you afford Mavenclad. Your health care provider will help you to get started with this program. For questions or more information, you can contact the drugmaker at 877-447-3243 or visit Mavenclad copay assistance program.
