Transcription of LEMTRADA (2.1) - Sanofi
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HIGHLIGHTS OF prescribing information DOSAGE AND ADMINISTRATION . These highlights do not include all the information needed to use LEMTRADA safely and Administer LEMTRADA by intravenous infusion over 4 hours for 2 treatment courses: effectively. See full prescribing information for LEMTRADA . First course: 12 mg/day on 5 consecutive days. ( ). Second course: 12 mg/day on 3 consecutive days 12 months after first treatment course. LEMTRADA (alemtuzumab) injection, for intravenous use ( ). Initial Approval: 2001 Premedicate with corticosteroids prior to LEMTRADA infusion for the first 3 days of each treatment course. ( ). Administer antiviral agents for herpetic prophylaxis starting on the first day of LEMTRADA . dosing and continuing for a minimum of two months after completion of LEMTRADA dosing WARNING: AUTOIMMUNITY, INFUSION REACTIONS, AND MALIGNANCIES or until CD4+ lymphocyte count is more than 200 cells per microliter, whichever occurs later. See full prescribing information for complete boxed warning.
FULL PRESCRIBING INFORMATION WARNING: AUTOIMMUNITY, INFUSION REACTIONS, AND MALIGNANCIES • LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease.
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Particulate Matter in Injectable Drug Products, DRUG, Q1A(R2) Guideline Stability Testing of New Drug, PRODUCTS, Stability Testing of new Drug, Stability testing of new drug substances and products, BRACKETING AND MATRIXING DESIGNS FOR STABILITY, BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING