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
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.
