Liver toxicity warning added to Prezista PI

March 14, 2008

Tibotec Pharmaceuticals updates prescribing information for darunavir (Prezista) to warn of hepatotoxicity

Clinical trial and postmarketing reports of drug-induced hepatotoxicity have led Tibotec Pharmaceuticals to update the prescribing information for darunavir (Prezista). Drug-induced hepatitis was reported in 0.5% of patients taking the protease inhibitor in combination with ritonavir during the clinical development program and, according to Tibotec, post-marketing cases of liver injury, including some fatalities, have since been reported. In general, the cases occurred in patients with advanced HIV-1 disease taking multiple other medications, with immune reconstitution syndrome, and those patients having co-morbidities such as hepatitis B or C co-infection. The update includes recommendations for appropriate laboratory testing prior to initiating treatment with darunavir as well as ongoing monitoring throughout therapy. AST/ALT lab values should be monitored in patients with underlying chronic hepatitis, those with elevated transaminases, and/or cirrhosis. Interruption or discontinuation of darunavir should be considered if there is evidence of new or worsening liver dysfunction. Questions should be directed to Tibotec Therapeutics Medical Information at 1-(877)-732-2488.

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