New Safety Information for Amevive (alefacept)
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New Safety Information for Amevive (alefacept)

CAMBRIDGE, MA -- November 10, 2005 -- Biogen Idec is informing healthcare providers of important new safety information regarding Amevive® (alefacept).

The new safety information includes contraindications and revisions to the content and format of other sections of the labeling.

Contraindications
Biogen Idec, in consultation with the United States Food and Drug Administration (FDA) is contraindicating Amevive in patients with HIV infection. This decision is based on the pathophysiology of HIV and the effect of Amevive on T lymphocytes. This contraindication is consistent with the company decision not to study Amevive in HIV positive psoriatic patients due to the theoretical safety concern in this patient population.

The new contraindication states: 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 (see WARNINGS, LYMPHOPENIA and WARNINGS, Serious Infections).

Numerous other sections of the product labeling have been revised to reflect additional safety experience (see Prescribing Information).

SOURCE: Biogen Idec

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