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Daily News: Safety Concerns with Etravirine
Friday October 30, 2009

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The U.S. Food and Drug Administration issued a healthcare provider alert for etravirine (Intelence) because of the potential increased risk of serious and fatal skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme. Hypersensitivity reactions also have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure.

Etravirine is a non-nucleoside reverse transcriptase inhibitor prescribed for treatment of HIV infection. Available as 100mg tablets, etravirine usually is prescribed as a twice-daily dose of 200 mg (two 100 mg tablets) following a meal.

Nurses caring for patients recently prescribed etravirine should pay especially careful attention to skin inspection and monitor for anaphylactic reactions. Reported rashes occurred most commonly during the first six weeks of therapy. Rashes may also be accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, and eosinophilia.

Patient teaching should stress careful inspection of the skin, especially when etravirine therapy is begun or dosages are adjusted. Although benign rashes also may occur with any medication, it is not possible to reliably predict which rashes will prove to be serious. Warn patients that if they notice any rashes they should immediately contact their healthcare provider. Patients should also be advised to immediately seek medical attention for any signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness). If signs or symptoms of severe skin reactions or hypersensitivity reactions develop, etravirine should be discontinued immediately because continued use can result in serious or fatal outcomes.



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