MAVENCLAD is thought to preferentially target B and T lymphocytes, and is associated with a reduction and subsequent recovery in lymphocyte count.1-3
Lymphocyte counts were measured as part of routine clinical laboratory evaluations in patients in clinical studies.7 MAVENCLAD causes a dose-dependent reduction in lymphocyte count. In clinical studies, 87% of MAVENCLAD-treated patients experienced lymphopenia. The lowest absolute lymphocyte counts occurred approximately 2 to 3 months after the start of each treatment course and were lower with each additional treatment course.6
In patients treated with MAVENCLAD as monotherapy, lymphopenia observed was transient and mostly mild to moderate.7 The median duration of severe lymphopenia was 6.0 weeks to improvement to Grade ≤2 and 28.1 weeks to recovery to Grade ≤1.7 26% and 1% of patients had nadir absolute lymphocyte counts less than 500 and less than 200 cells/μL, respectively.6 At the end of the second treatment course, 2% of clinical study patients had lymphocyte counts less than 500 cells/μL.6
Due to the post hoc nature of this analysis, no statistical significance between treatment groups can be drawn.
MAVENCLAD has an estimated terminal half-life of approximately 24 hours and is eliminated from the body in ~1 week1,6,10
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.