Mavenclad® is an approved oral medication indicated for relapsing forms of multiple sclerosis (MS). It includes the treatment of relapsing-remitting and active secondary progressive disease in adults. It comes in tablet form in a strength of 10 mg and is taken by mouth.1,2,3
Manufactured by EMD Serono, the biopharmaceutical business of Merck KGaA, Mavenclad is a short-course treatment that requires a maximum of 20 days of oral therapy to deliver two years of clinical benefit to a patient. The FDA has approved Mavenclad which has been available in 50 countries, including the European Union (EU) since August 2017.1,2
What are the ingredients in Mavenclad?
The active ingredient in Mavenclad is cladribine.1,2,3
How does Mavenclad work?
It is thought that Mavenclad works by having cytotoxic (toxic to living cells) effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. Lymphocytes are a type of white blood cell that plays a key role in the immune system’s inflammatory response. This depletion of B and T cells helps reduce inflammation and demyelination in the CNS.2
What are the possible side effects of Mavenclad?
Many clinical trials evaluated the safety and efficacy of Mavenclad. The most common side effects experienced by those taking Mavenclad include:2
Upper respiratory tract infection
Lymphopenia – having lower-than-normal number of lymphocytes, a type of white blood cell, in the blood
This is not an exhaustive list of all potential side effects of Mavenclad. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Mavenclad, contact your doctor or healthcare provider promptly.
Things to note about Mavenclad
Mavenclad is generally recommended for adults who have had an inadequate response to, or cannot tolerate, alternate drugs indicated for the treatment of MS. This is because of Mavenclad’s safety profile which can reduce the body’s immune defense system and increase risk of infections and malignancies.1,2,3
Mavenclad is a purine antimetabolite. It contains the nucleoside metabolic inhibitor cladribine, which is a white or almost white, non-hydroscopic crystalline powder. The tablets are white and uncoated.
Before starting Mavenclad, your doctor should assess the appropriateness of the treatment and consider any other conditions you may have and medications you may take. This includes presence or history of cancer, pregnancy, full blood counts, infections, or liver injury.
Be sure to talk with your doctor if you:2
Have a current malignancy
Are pregnant or planning to get pregnant, as Mavenclad may cause fetal harm. It should not be used by men or women during or for 6 months after the last dose in a course of treatment
Have chronic infections such as hepatitis or TB
Have a history of hypersensitivity to cladribine
Women intending to breastfeed should delay use until 10 days after the last dose
Take certain medications including immunosuppressive, myelosuppressive or some immunomodulatory drugs such as interferon beta, because use of Mavenclad at the same time can increase the risk of adverse reactions
Talk to your doctor if you take certain antiviral or antiretroviral drugs as they may affect the effectiveness of Mavenclad.
Individuals with the above conditions should be monitored closely while taking Mavenclad. Because of its safety profile, Mavenclad is not recommended for use in patients with clinically isolated syndrome (CIS).
All vaccines should be up to date prior to starting Mavenclad. Any live-attenuated or live vaccines should be given at least 4 to 6 weeks prior to starting Mavenclad to avoid risk of vaccine-related infection.2
Mavenclad comes in 10 mg tablets. The recommended cumulative dosage of Mavenclad depends on your size. Your doctor will calculate individual dosage based on a ratio of 3.5 mg of medication per kg of body weight. Mavenclad is administered orally and divided into 2 yearly treatment courses (1.75 mg per kg per treatment course). Each treatment course is divided into 2 treatment cycles. The first cycle of the first treatment course can be started at any time. The second cycle of the first course is started 23 to 27 days after the last dose of the first cycle. The second treatment course is administered at least 43 weeks after the last dose of the second cycle of the first course. The second cycle of the second course also begins 23 to 27 days after the last dose of the first cycle of the Second Course. Do not take more than 2 tablets daily.
If a dose is missed, do not take double or extra doses. If a dose is not taken on the scheduled day, the missed dose can be taken on the following day, extending the number of days in that treatment cycle. If two consecutive doses are missed, the treatment cycle is extended by 2 days.
Mavenclad has special handling and disposal procedures. It is stored in a child-resistant blister pack at room temperature. Tablets must be swallowed immediately after being removed from the blister. If a tablet is left out or is broken, the area must be thoroughly washed with water because of its cytotoxic properties. To dispense Mavenclad, hands must be dry, and after taking out the medication hands must be washed thoroughly.
Prolonged skin contact should be avoided.
Up to 2 treatment courses of Mavenclad may be administered, but additional courses of treatment should not be repeated during the next 2 years following treatment completion.
Mavenclad tablets are taken orally with water, and swallowed whole without chewing or grinding. They can be taken with or without food. Take Mavenclad at least 3 hours apart from other medicines taken by mouth during the 4 or 5 day MAVENCLAD treatment week.2
For additional details, read the full prescribing information of Mavenclad available here .
Press Release: FDA Approves MAVENCLAD® (Cladribine) Tablets as First and Only Short-Course Oral Treatment for Relapsing-Remitting and Active Secondary Progressive Multiple Sclerosis. Available at:
http://media.emdserono.com/2019-03-29-FDA-Approves-MAVENCLAD-R-Cladribine-Tablets-as-First-and-Only-Short-Course-Oral-Treatment-for-Relapsing-Remitting-and-Active-Secondary-Progressive-Multiple-Sclerosis. Accessed 4.9.19
Prescribing Information for Mavenclad. Available at: https://www.emdserono.com/content/dam/web/corporate/non-images/country-specifics/us/pi/mavenclad-pi.pdf. Accessed 4.09.19.
Mavenclad: Now Approved. Available at: https://www.mavenclad.com/en/now-approved/index. Accessed 4.09.19.