"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
The highest dose tested in humans (0.75 mg/kg intravenous) was associated with chills, headache, arthralgia, and sinusitis within one day of dosing. Patients who have been inadvertently administered an excess of the recommended dose should be closely monitored for effects on total lymphocyte count and CD4+ T lymphocyte count.
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 AND PRECAUTIONS].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/8/2012
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