Special Alerts:

[Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for darunavir (Prezista) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with darunavir/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/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 darunavir/ritonavir treatment. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista, http://www.fda.gov/medwatch/safety/2008/prezista_DHCP.pdf and http://www.fda.gov/cder/foi/label/2008/021976s003s004lbl.pdf.