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U.S. Department of Health and Human Services

Safety

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Amevive (alefacept)

Audience: Dermatologists and other healthcare professionals

[Posted 11/10/2005] Biogen Idec and FDA notified healthcare professionals of revisions to CONTRAINDICATIONS section of the prescribing information for Amevive, indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Amevive should not be administered to patients infected with HIV. Amevive reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease in these patients. In addition, other sections of the product labeling were revised to reflect additional safety information.

[October 2005 - Letter - Biogen Idec]
[September 2005 - Label - Biogen Idec]