Label Changes for:

Prezista (darunavir) Tablets

March 2008

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Hepatotoxicity

PRECAUTIONS

  • Patients with co-existing conditions
    • Hepatic Impairment
  • Table 11
    • HMG-CoA Reductase Inhibitors
      • Rosuvastatin

ADVERSE REACTIONS

  • Patients co-infected with hepatitis B and/or hepatitis C virus

PATIENT PACKAGE INSERT

  • What should I tell my doctor before I take Prezista?
    • have liver problems, including hepatitis B or C
  • Can Prezista be taken with other medications?
    • Digoxin (Lanoxin)
  • What are the possible side effects of Prezista?
    • Your healthcare professional should do blood tests prior to initiating combination treatment including Prezista...

WARNINGS: 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 pre-existing 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 HIV-1 disease taking multiple concomitant medications, having co-morbidities including hepatitis B or C co-infection, 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 pre-treatment elevations of transaminases, especially during the first several months of Prezista/rtv treatment...

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