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Label Changes for:

Prezista (darunavir) suspension and tablets

December 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011




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.