Learn about assessments and lymphocyte monitoring for MAVENCLAD.
Obtain a CBC with differential including lymphocyte count. Lymphocytes must be:
If necessary, delay the second treatment course for up to 6 months to allow for recovery of lymphocytes to at least 800 cells/μL. If this recovery takes more than 6 months, the patient should not receive further treatment with MAVENCLAD.
Exclude current malignancy. In patients with a prior malignancy, evaluate the benefits and risks from an individual patient basis. Follow standard cancer screening guidelines.
Exclude pregnancy prior to treatment with MAVENCLAD in females of reproductive potential.
Inform women that breastfeeding is not advised on MAVENCLAD treatment days and for 10 days after the last dose.
Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels.
Initiation of MAVENCLAD in patients currently receiving immunosuppressive or myelosuppressive therapy is not recommended.
Obtain lymphocyte count at 2 and 6 months after start of treatment in each treatment course
There are other important considerations when starting and continuing treatment with MAVENCLAD. Please refer to the full Prescribing Information, including boxed WARNING, for more information.
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.