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U.S. Department of Health and Human Services

Safety

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Prezista (darunavir) suspension and tablets

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

 

April 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.3 Severe Skin Reactions
  • During the clinical development program (n=3063), severe skin reactions, accompanied by fever and/or elevations of transaminases in some cases, have been reported in 0.4% of subjects. Stevens-Johnson Syndrome was rarely (less than 0.1%) reported during the clinical development program. During post-marketing experience toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and .....

7 DRUG INTERACTIONS

  • added ....information for dolutegravir and in vitro antiviral activity data for rilpivirine


NOTE:  information related to the 400 mg tablet strength of darunavir and ergonovine were removed because they are no longer marketed and distributed in the United States.

 

December 2011

Summary View

ADVERSE DRUG REACTIONS

Was update to reflect clinical trial experience in pediatric patients from Study TMC1140C228 as follows:

  • ADRs to Prezista/ritonavir (all grades, greater than or equal to 3%), excluding laboratory abnormalities, were diarrhea (19%), vomiting (14%) and rash (10%).
  • There were no Grade 3 or 4 laboratory abnormalities considered as ADRs in this study.