Raptiva ( Efalizumab) is 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.
Genentech has revised the Prescribing Information including a new warning regarding events of immune-mediated haemolytic anemia, an updated Warnings regarding postmarketing reports of serious infections and thrombocytopenia.
Two cases of hemolytic anemia were observed in Raptiva clinical trials.
Two additional cases were reported in the postmarketing setting.
In two severe cases the hemoglobin decreased to 6 and 7 g/dL.
A causal relationship between Raptiva and these events has not been established but cannot be excluded.
Based on this data, the following warning has been added to the prescribing information:
Reports of hemolytic anemia, some serious, diagnosed 4-6 months after the start of Raptiva treatment have been received.
Raptiva should be discontinued if hemolytic anemia occurs.
The Warnings section concerning serious infections has been updated to include rare postmarketing reports of 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.
Source: Genentech, 2005