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FDA and Tibotec Dear Healthcare Professional Letter Regarding NewPrescribing Information for Prezista (darunavir)

ROCKVILLE, Md., March 12, 2008--Tibotec Therapeutics, in cooperation with the U.S. Food and Drug Administration, issued a Dear Healthcare Professional letter to relay important, updated prescribing information for PREZISTA (darunavir) tablets, that includes a warning about Hepatotoxicity.

The letter provides, in addition to other information, the following, which has been added to the WARNINGS section of the Prezista label:

""Hepatotoxicity " Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/rtv. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA/rtv. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe hepatic adverse events.

Postmarketing cases of liver injury, including some fatalities, have been reported. These have generally occurred in patients with advanced HIV1 disease taking multiple concomitant medications, having comorbidities including hepatitis B or C coinfection, and/or developing immune reconstitution syndrome. A causal relationship with PREZISTA/rtv therapy has not been established.

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/rtv 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/rtv treatment.

If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/rtv, interruption or discontinuation of treatment must be considered."

In addition, the Adverse Reaction section of the PREZISTA label and the Patient Package Insert have been updated to include this new information.

The letter and the new label are available in pdf format from the Tibotec web site.

Richard Klein Office of Special Health Issues Food and Drug Administration

Kimberly Struble Division of Antiviral Drug Products Food and Drug Administration


Posted: March 2008