Tesamorelin (Egrifta)
Tesamorelin acetate (trans-3-hexenoic acid-GHRH(1-44)-NH2; TH9507)
Approved status applies to specific products, routes, and indications, not every use context discussed online.
An FDA-approved daily injection (Egrifta, Egrifta SV) for HIV-positive adults who develop excess belly fat as a side effect of their HIV medications. It works by triggering the body's natural growth hormone release to selectively reduce deep abdominal fat.
Safety Summary
Overall well-tolerated at approved dose (2 mg SC daily). Most adverse events are Grade 1-2 and consistent with effects of increased GH levels (fluid retention, joint pain). Immunogenicity: anti-tesamorelin IgG antibodies developed in ~49-50% of treated patients in pooled Phase 3 data; antibody titers decline over time and no neutralizing effect on efficacy or clear clinical adverse consequences demonstrated (up to 52 weeks). Glucose monitoring required (GH/IGF-1 axis stimulation can worsen glycemic control); blood glucose and HbA1c should be monitored especially in patients with or at risk for diabetes. No evidence of tachyphylaxis through 52 weeks of continuous treatment. VAT reaccumulates upon discontinuation. No classical dependence or withdrawal syndrome. Long-term cancer risk is theoretical (IGF-1 elevation is mitogenic); FDA mandated long-term post-marketing observational study to monitor cancer incidence. EMA flagged insufficient long-term safety data when MAA was withdrawn.
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-6]