Pharmacy Services
Darunavir (Prezista) - Hepatotoxicity Warnings
March 14, 2008
The FDA and Tibotec Therapeutics have updated the product labeling to darunavir (Prezista) after reviewing clinical trials and post-marketing data regarding drug-induced hepatoxicity associated with darunavir and ritonavir combination therapy. Hepatitis was reported in 0.5% of patients receiving combination therapy. Patients with existing liver complications, including hepatitis B or C, are at a higher risk for liver injury.
Perform proper laboratory testing prior to initiating combination therapy and throughout treatment. Increase AST/ALT monitoring in the first several months of treatment in patients with cirrhosis, underlying chronic hepatitis, or pretreatment elevations of transaminases. Discontinue or interrupt treatment with darunavir if signs and symptoms of liver dysfunction are new or become worse. These may include symptoms such as anorexia, dark urine, fatigue, jaundice, hepatomegaly, liver tenderness, and nausea.
Additional information is available at the following links:
- FDA MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094964.htm - Dear Healthcare Professional Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm129682.pdf - Information for Healthcare Professional:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109402.htm - Darunavir Prescribing Information and Patient Information:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf
Updated
March 21, 2008; March 13, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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