*Each week of MAVENCLAD treatment is known as a cycle and consists of 1 or 2 MAVENCLAD pills a day for 4 or 5 days (depending on body weight) in a row. There are 2 MAVENCLAD cycles a year, about a month apart, for 2 years. Continue to monitor patients’ health during the 2 yearly treatment courses as well as between treatment courses and for at least another 2 years, during which patients do not need to take MAVENCLAD.
†Some limitations are required by law. Patients covered by federal or state healthcare programs, including Medicare and Medicaid, are not eligible for assistance. This program is open to residents of the U.S. and U.S. Territories with relapsing forms of multiple sclerosis who are starting MAVENCLAD therapy or presently taking MAVENCLAD.
MAVENCLAD® (cladribine) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.
Limitations of Use: MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
WARNINGS AND PRECAUTIONS
Adverse Reactions: The most common adverse reactions (incidence of >20%) are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions: Concomitant use of with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered. Monitor for additive effects on the hematological profile with use of hemotoxic drugs. Avoid concomitant use of antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.
Use in Specific Populations: Studies have not been performed in pediatric, or elderly patients >65 years, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.
To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono, Inc. at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.