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U.S. Department of Health and Human Services


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Raptiva (efalizumab) Revised Warnings

Audience: Dermatological and other healthcare professionals

[Posted 07/20/2005] Genentech and FDA revised the WARNINGS, ADVERSE REACTIONS sections and Patient Information Sheet for RAPTIVA (efalizumab), indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Healthcare professionals and patients were informed about reports of immune-mediated hemolytic anemia and warnings regarding postmarketing reports of thrombocytopenia and serious infections including necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment.

[July 15, 2005 - Letter - Genentech]
[June 2005 - Label - Genentech]