Is Enfuvirtide safe?
Trial safety data, near-universal site reactions
Injection-site reactions were close to universal. In TORO 1, 98% of enfuvirtide patients had pain, redness, nodules or cysts at injection sites. About 4% stopped treatment because of them. The trials also found a higher rate of bacterial pneumonia in the enfuvirtide arm, which the label flagged. Rare hypersensitivity reactions also occurred. Diarrhea, nausea and fatigue were otherwise similar to controls. 12
Injection-site reactions in 98% of patients, a modestly higher rate of bacterial pneumonia, and rare hypersensitivity. Body-wide side effects were otherwise similar to background therapy alone. 12
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