Label Changes for:
Intelence (etravirine) Tablets
February 2013
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) –
February 2013
WARNINGS AND PRECAUTIONS
Severe Skin and Hypersensitivity Reactions
- Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens- Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction...
