The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes

MAVENCLAD is a purine antimetabolite 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.

• Assessments are required prior to starting each MAVENCLAD treatment course. • Cumulative dosage of 3.5 mg/kg administered orally and divided into 2 treatment courses (1.75 mg/kg per treatment course). Each treatment course is divided into 2 treatment cycles. • MAVENCLAD is a cytotoxic drug. • Separate administration from any other oral drug by at least 3 hours.

Most common adverse reactions (incidence > 20%) are upper respiratory tract infection, headache, and lymphopenia.

• Patients with current malignancy. • Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during MAVENCLA D dosing and for 6 months after the last dose in each treatment course. • HIV infection. • Active chronic infections (e.g., hepatitis or tuberculosis). • History of hypersensitivity to cladribine. • Women intending to breastfeed on a MAVENCLAD treatment day and for 10 days after the last dose. (4, 8.2)

• Lymphopenia: Monitor lymphocyte counts before, during and after treatment. • Infections: Screen patients for latent infections; consider delaying treatment until infection is fully controlled. Vaccinate patients antibodynegative to varicella zoster virus prior to treatment. Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter. Monitor for infections. • Hematologic toxicity: Measure complete blood count annually if clinically indicated after treatment. • Graft-versus-host-disease with blood transfusion: Irradiation of cellular blood components is recommended. • Liver injury: Obtain tests prior to treatment. Discontinue if clinically significant injury is suspected.