Screening and monitoring should be performed before, during, and after treatment. Each treatment week, taken about a month apart, consists of 1 or 2 MAVENCLAD pills a day for 4 or 5 days in a row. Dosing depends on weight.
In CLARITY, MAVENCLAD significantly reduced the annualized relapse rate vs placebo at 96 weeks.1,2
ARR: annualized relapse rate; CI: confidence interval; CLARITY: CLAdRIbine Tablets treating multiple sclerosis orallY.
In CLARITY, MAVENCLAD significantly reduced the risk of 3-month confirmed EDSS progression vs placebo.1,2
Disability progression was measured in terms of a 3-month sustained change in EDSS score of ≥1 point, if baseline EDSS score was between 0.5 and 4.5 inclusively, or ≥1.5 points if the baseline EDSS score was 0, or ≥0.5 point if the baseline EDSS score was ≥5, over a period of at least 3 months.2
*Proportion of patients with 3-month EDSS progression (MAVENCLAD 13% vs placebo 19%).1
CI: confidence interval; CLARITY: CLAdRIbine Tablets treating multiple sclerosis orallY; EDSS: Expanded Disability Status Scale; HR: hazard ratio.
MAVENCLAD demonstrated a significant reduction in mean and median numbers of active T1-Gd+ and active T2 lesions at 2 years vs placebo.1,2
The mean relative reduction reflects that not all patients had lesions at 96 weeks compared to placebo. Patients taking MAVENCLAD had fewer T1-Gd+ lesions: 13.2% taking MAVENCLAD vs 51.7% on placebo. Patients taking MAVENCLAD had fewer active T2 lesions: 38.3% taking MAVENCLAD vs 71.6% on placebo.2,3
CLARITY: CLAdRIbine Tablets treating multiple sclerosis orallY; T1-Gd+: T1 gadolinium-enhanced.
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.