FUZEON: Avoiding Injection-Site Reactions

Summary: The FDA changed the FUZEON prescribing information to help avoid this common and unpleasant side effect of the drug.

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On January 31 the FDA announced that the FUZEON (enfuvirtide) package insert had been changed to include precautions to avoid injection-site reactions, either using a needle, or the Biojector(r) 2000 needlefree injection system. For example, here is one place where changes were made (this is from the new version):

“Patients and caregivers should be instructed on the preferred anatomical sites for administration (upper arm, abdomen, anterior thigh). FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial sections of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, tattoos or burn sites.”

The changes are at:
http://www.fda.gov/oashi/aids/listserve/listserve2007.html#013007

And the complete revised prescribing information is at:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2705

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