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FDA Updates Raltegravir (Isentress) Label with New Information on Severe Skin and Hypersensitivity Reactions

Posted November 2011

“Updates to the Isentress (raltegravir) package insert were approved on November 2, 2011 to include a new subsection in the Warnings and Precautions section and update the postmaketing experience section. Specifically, the following subsection was added to section 5 Warnings and Precautions:

“5.1 Severe Skin and Hypersensitivity Reactions

“Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure. Discontinue ISENTRESS and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping ISENTRESS treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.

“In Section 6 Adverse Reactions, subsection 6.2 Postmarketing Experience, cerebellar ataxia and drug rash with eosinophilia and systemic symptoms was added.

“The Patient Counseling Information section and the patient labeling was also revised to incorporate these changes.”

The updated label will be available at the FDA Web site.

More information is available: