Raptiva Label Warns of Opportunistic Infections
The U.S. Food & Drug Administration (FDA) announced on Oct. 16 labeling changes, including a boxed warning, to highlight the risks of life-threatening infections with the use of Raptiva (efalizumab). The FDA requires the submission of a Risk Evaluation and Mitigation Strategy (REMS), which includes a medication guide for patients and a timetable for REMS assessment.
“As part of FDA’s monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling,” said Janet Woodcock, the FDA’s director of the Center for Drug Evaluation and Research. “Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks.”
Raptiva, approved in 2003 and manufactured by Genentech, Inc., is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.
The now-required boxed warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections. Raptiva’s label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). Data will indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children less than 18 years of age.
Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Consumers and health care professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online.