MAVENCLAD is the first and only oral MS treatment to provide proven efficacy over 96 weeks with a maximum of 10 days of treatment a year for 2 years1,2
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.
The recommended cumulative dosage of MAVENCLAD is 3.5 mg/kg body weight administered orally and divided into 2 yearly treatment courses (1.75 mg/kg per treatment course). View the full MAVENCLAD dosing guide.
Year 1 treatment course:
Year 2 treatment course:
Administer the cycle dosage as 1 or 2 tablets once daily over 4 or 5 consecutive days. Do not administer more than 2 tablets daily.
The distribution of the number of tablets across the 2 treatment cycles is provided below. The dosing schedule is the same for both treatment courses (years 1 and 2), although the number of pills per treatment cycle may vary. Patients in the 40- to <50-kg (≈88 to <110 lb) weight range have only 4 days of treatment per treatment cycle, while all other weight ranges have 5 days.
Following the administration of 2 treatment courses, do not administer additional MAVENCLAD treatment during the next 2 years. Treatment during these 2 years may further increase the risk of malignancy. The safety and efficacy of reinitiating MAVENCLAD more than 2 years after completing 2 treatment courses has not been studied.
Patients are dispensed a 1-week supply of MAVENCLAD 10 mg tablets for each treatment cycle with individualized day packs based on weight. Each day pack is filled with 1 or 2 tablets and labeled according to the day that the patient should take them. Packaging will vary based on patient weight and is differentiated by color for safety. MAVENCLAD is a cytotoxic drug. Follow applicable special handling procedures.1
If a dose is missed, patients should not take double or extra doses.
MAVENCLAD tablets, 10 mg, are white, round, biconvex, and engraved with a “C” on one side and “10” on the other side. Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original package in order to protect from moisture.
Instruct patients that MAVENCLAD is a cytotoxic drug and to use care when handling MAVENCLAD tablets. Limit direct skin contact with the tablets and wash exposed areas thoroughly. Advise patients to keep the tablets in the original child-resistant blister packaging until just prior to each scheduled dose and consult their pharmacist on the proper disposal of unused tablets.
View helpful information to consider prior to prescribing MAVENCLAD for your patients, and learn about ways to prescribe.
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Adverse Reactions: The most common adverse reactions with an incidence of >20% for MAVENCLAD are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions/Concomitant Medication: Concomitant use of MAVENCLAD 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.
Avoid concomitant use of certain 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, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.
Please see the full Prescribing Information, including boxed WARNING for additional information.
MAVENCLAD® (cladribine) tablets 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
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Adverse Reactions: The most common adverse reactions with an incidence of >20% for MAVENCLAD are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions/Concomitant Medication: Concomitant use of MAVENCLAD 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.
Avoid concomitant use of certain 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, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.
Please see the full Prescribing Information, including boxed WARNING for additional information.