Safety Alerts & Recalls

What does this mean?

The risk of serious skin reactions and hypersensitivity reactions associated with Intelence is well known by doctors who treat patients with HIV infections. In general, the benefits of Intelence will outweigh the risks of these serious reactions. This updated safety information stresses the importance of watching for signs of skin reactions and hypersensitivity reactions, including signs of severe rash or rash accompanied by fever; blisters; oral sores; fatigue, muscle or joint aches or other flu-like symptoms; or swelling of the face, mouth, or throat. If you experience any of these symptoms, please contact your doctor immediately.

If you have any additional questions or concerns about Intelence, please follow up with your doctor or pharmacist.

Warning About Serious Skin Reactions with Use of Intelence

Tibotec Therapeutics, along with the FDA, has announced an important safety update to the Severe Skin Reactions WARNINGS AND PRECAUTIONS section of the Intelence (etravirine) prescribing information. The Severe Skin Reactions warning now includes information about post-marketing reports of Stevens-Johnson syndrome and toxic epidermal necrolysis, both are serious skin reactions that have led to death. There have also been reports of hypersensitivity reactions with symptoms of rash and have sometimes included liver failure. The prescribing information also warns that Intelence should be stopped immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop.

Intelence is a type of anti-HIV (Human Immunodeficiency Virus) medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used in combination with other anti-HIV medicines to control HIV infection in adults.

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Source: Manufacturer
Publication Date: 2009-08-28
Last Updated: 2010-12-06

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