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.
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HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.
Taking ritonavir will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.
Ritonavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Ritonavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.
Ritonavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Ritonavir is not a cure for HIV or AIDS.
Ritonavir may also be used for purposes other than those listed in this medication guide.
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