Active Ingredient: Alemtuzumab
Alemtuzumab is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
12 - 12 mg
From 12 To 12 mg once every day
The recommended dose of alemtuzumab is 12 mg/day administered by intravenous infusion for 2 initial treatment courses, with up to 2 additional treatment courses if needed.
Initial treatment of 2 courses:
Up to two additional treatment courses, as needed, may be considered:
Missed doses should not be given on the same day as a scheduled dose.
The therapy is recommended as an initial treatment of 2 courses with up to 2 additional treatment courses if needed with safety follow-up of patients from initiation of the first treatment course and for at least 48 months after the last infusion of the second treatment course. If an additional third or fourth course is administered, continue safety follow-up for at least 48 months after the last infusion.
Patients should be pre-treated with corticosteroids immediately prior to alemtuzumab administration on each of the first 3 days of any treatment course. In clinical trials, patients were pre-treated with 1,000 mg methylprednisolone for the first 3 days of each alemtuzumab treatment course.
Pretreatment with antihistamines and/or antipyretics prior to alemtuzumab administration may also be considered.
Oral prophylaxis for herpes infection should be administered to all patients starting on the first day of each treatment course and continuing for a minimum of 1 month following treatment with alemtuzumab. In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.
Alemtuzumab must be diluted before infusion. The diluted solution should be administered by intravenous infusion over a period of approximately 4 hours.
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