Pill Identifier App

Label Changes for:

Intelence (etravirine) tablet

December 2010

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 2010

 

ADVERSE REACTIONS

Postmarketing Experience
  • Rhabodomyolysis

PATIENT COUNSELING INFORMATION

What are the possible side effects of Intelence?
  • Muscle pain or tenderness
  • Patients should be advised to seek medical attention if... severe hypersensitivity: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes, lips, mouth, breathing difficulty, and/or signs and symptoms of liver problems (e.g., yellowing of your skin or whites of your eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs). Patients should understand that if severe rash occurs, they will be closely monitored, laboratory tests will be ordered and appropriate therapy will be initiated.
Hide
(web2)