Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Food and Drug Administration - March 12, 2008
Richard Klein & Kimberly Struble
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
080312
FD080303
SOURCE: Food and Drug Administration (FDA).
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