Label Changes for:
Isentress (raltegravir potassium) tablets
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) -- July 2009
- addition of paranoia and anxiety
- warning about use with UGT (UDP-glucuronosyltransferases) inducers other than rifampin, specifically, Coadministration of Isentress with drugs that are strong inducers of UGT1A1 may result in reduced plasma concentrations of raltegravir