Hepatitis warning added to Prezista label

PREZISTA (darunavir) tablets by Tibotec
PREZISTA (darunavir) tablets by Tibotec

The labeling for Prezista (darunavir, from Tibotec Therapeutics) has been updated to include a hepatotoxicity warning. In clinical trials and post-marketing experience, drug-induced hepatitis has been reported in patients receiving Prezista/ritonavir combination therapy. Based on these reports, appropriate laboratory testing should be conducted prior to the initiation of Prezista/ritonavir therapy and patients should continue to be monitored during treatment. Increased AST/ALT monitoring should also be considered in patients with pre-existing liver dysfunction or elevated transaminase levels, especially during the first several months of Prezista/ritonavir treatment.

Prezista, a protease inhibitor, co-administered with ritonavir and other antiretroviral agents, is indicated for the treatment of HIV in antiretroviral treatment-experienced adults.

For more information call (877) REACH TT or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094964.htm.