Two New Fixed-Dose Combinations Approved
August 2, 2004
FDA announced approval today, August 2, 2004, of two fixed-dose combination (FDC) antiretroviral drug products for use with other antiretroviral agents for the treatment of HIV-1 infection. The FDCs are GlaxoSmithKline's EPZICOMTM (abacavir/lamivudine) and Gilead Sciences, Inc.'s TRUVADATM (tenofovir disoproxil/emtricitabine).
These FDC approvals are important because they provide simplified dosing regimens -- one pill, once daily, for the component of multi-drug therapy represented by these FDCs.
TRUVADATM (Tenofovir Disoproxil/Emtricitabine) -- Gilead Sciences, Inc.
EPZICOMTM (Abacavir/Lamivudine) -- GlaxoSmithKline
The important safety issue regarding abacavir-containing products, including EPZICOM, is abacavir hypersensitivity reaction (a serious allergic reaction). Previous clinical trials showed that there is a possibility of this hypersensitivity reaction occurring in approximately 8% of the patients. EPZICOM should be discontinued a soon as a hypersensitivity reaction is suspected. EPZICOM or other abacavir-containing products must not be restarted following a hypersensitivity reaction because more severe symptoms can occur within hours and may include life-threatening hypotension and death. Information on this serious allergic reaction has been updated in the EPZICOM package insert as well as the patient Medguide/Warning Card.
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