Hypersensitivity enfuvirtide

Enfuvirtide is contraindicated in patients with known hypersensitivity to enfuvirtide or any of its components (see Warnings). 

Local injection site reactions The most common adverse events associated with enfuvirtide use are local injection site reactions. Manifestations may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, and ecchymosis. Pneumonia An increased rate of bacterial pneumonia was observed in subjects treated with enfuvirtide in the phase 3 clinical trials compared with the control arm. Hypersensitivity reactions Hypersensitivity reactions have been associated with enfuvirtide therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination Rash, fever, nausea and vomiting, chills. 

Enfuvirtide Fusion inhibitor 90 mg subcutaneously bid Store at room temperature as a powder refrigerate once reconstituted Local injection site reactions, hypersensitivity reaction ... 

The most common adverse effects associated with enfuvirtide therapy are local injection site reactions. Hypersensitivity reactions may rarely occur, are of varying severity, and may recur on rechallenge. Eosinophilia has also been noted. In one prospective clinical trial, an increased rate of bacterial pneumonia was noted in patients receiving enfuvirtide. No interactions have been identified that would require the alteration of the dosage of other antiretroviral drugs. 

Skin Local injection site reactions are common with enfuvirtide. In the TORO 2 study, among the 338 patients given enfuvirtide 98% had at least one injection site reaction. The common signs and symptoms of injection site reactions were induration, erythema, nodules, and cysts only 3.3% discontinued treatment as a result [213 ]. There were similar and consistent findings in the TORO 1 study, which was conducted in North and South America [214 ]. Biopsies of the lesion showed an inflammatory response consistent with a localized hypersensitivity reaction [216 ]. In a 47-year-old man amyloidosis occurred at the injection site [217 ]. 

Immunologic Of the 663 patients who took enfuvirtide group in the TORO 1 and 2 studies, two had systemic hypersensitivity reactions. Both recurred on rechallenge. In the first case, the reaction occurred after 8 days of treatment and was associated with a rash, fever, and vomiting [214 "]. Delayed hypersensitivity reactions can occur [218 ]. 

Emerson CR, Post JJ, Workman C. A delayed hypersensitivity reaction to enfuvirtide after rechallenge. Int J STD AIDS 2009 20(4) 288-9. 

---