Audience: Infectious disease healthcare professionals[UPDATE 3/21/2008] FDA issued a new "Information for Healthcare Professionals" sheet highlighting the addition of hepatotoxicity information to the WARNINGS section of prescribing information for Prezista.
[Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.
[March 21, 2008 - Information for Healthcare Professionals - FDA]
[March 2008 - Dear Healthcare Professional Letter - Tibotec]