FDA Approves Mavenclad (cladribine) for Relapsing Forms of Multiple Sclerosis
The FDA has approved Mavenclad (cladribine), a purine antimetabolite, for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting disease and active secondary progressive disease. The approval is based on the drug's ability to reduce relapses and slow disability progression, though specific clinical trial data are not detailed in the label. Mavenclad is generally reserved for patients who have had an inadequate response to or cannot tolerate other MS therapies, reflecting its safety profile. The drug carries a boxed warning for increased risk of malignancies, and its use is not recommended in patients with clinically isolated syndrome. Clinicians should carefully assess patients before initiating treatment, including cancer screening, pregnancy exclusion, and monitoring of lymphocyte counts.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mavenclad is a purine antimetabolite. The exact mechanism by which it exerts therapeutic effects in multiple sclerosis is not fully understood, but it is thought to involve a reduction in lymphocytes.
Mavenclad 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 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.
Assessments are required prior to starting each treatment course, including cancer screening, pregnancy exclusion, complete blood count with differential (lymphocytes must be within normal limits before first course and at least 800 cells/mcL before second course), infection screening (HIV, TB, hepatitis B and C), and liver function tests. The recommended cumulative dosage is 3.5 mg/kg orally divided into 2 yearly treatment courses (1.75 mg/kg per course). Each course is divided into 2 cycles, administered as 1 or 2 tablets once daily over 4 or 5 consecutive days. The second cycle is given 23 to 27 days after the last dose of the first cycle. The second treatment course is given at least 43 weeks after the last dose of the first course. Do not administer more than 2 tablets daily. After 2 treatment courses, no additional Mavenclad treatment should be given for the next 2 years. Mavenclad is a cytotoxic drug; separate administration from any other oral drug by at least 3 hours.
Trial data not available in label.
Warnings include increased risk of malignancies (boxed warning), hematologic toxicity (lymphopenia), infections (including PML), liver injury, and fetal harm. Contraindications include pregnancy and HIV infection. Prior to each treatment course, exclude pregnancy, obtain CBC with differential, screen for infections, and assess liver function. Vaccination for VZV is recommended. Live vaccines should be given at least 4 to 6 weeks before starting Mavenclad.
Mavenclad is a second-line or later therapy for relapsing forms of MS, reserved for patients who have had an inadequate response to or cannot tolerate other MS drugs. Its use is limited by safety concerns, including malignancy risk, and it is not recommended for CIS. The recommended duration is 2 treatment courses over 2 years, with no additional treatment for at least 2 years thereafter.
View Original Abstract ↓
Intravenous tenecteplase improves functional outcomes but increases hemorrhage risk in non-large vessel occlusion acute ischemic stroke
Tenecteplase improves stroke recovery but increases bleeding risk in late treatment window
Related in Neurology
From Other Specialties
