Tesamorelin: approved dosage in the US

Not a recommendation, not treatment guidance. This page shows only the dosing in the official product information, with sources. The dose is always decided by the doctor who prescribes the medicine. Fimea warns against using injectable peptides bought online: Fimea warning.

Source of the dosing: Egrifta WR (tesamorelin), FDA prescribing information (FDA), date of the text 3/2025 [1]official; Egrifta SV (tesamorelin), FDA prescribing information, date of the text 2/2024 [2]official

Tesamorelin has no marketing authorisation in the EU: the application for Egrifta (tesamorelin) to the EMA was withdrawn in 2012 [4]regulator.

In the United States the FDA has approved two products, Egrifta WR (tesamorelin) and Egrifta SV (tesamorelin), to reduce excess abdominal fat in adults with HIV and lipodystrophy [1, 2]official. The two differ in dose and strength and are not interchangeable [1]official.

Dosing in the product information

Dosing in the official product information. Not a recommendation.
Product and stepIndicationDoseFrequencyDurationSource and level
Egrifta WR (tesamorelin) Excess abdominal fat in adults with HIV and lipodystrophy 1.28 mg under the skin Once a day Not set in the label [1]official
Egrifta SV (tesamorelin) Excess abdominal fat in adults with HIV and lipodystrophy 1.4 mg under the skin Once a day Not set in the label [2]official

Evidence levels: official = official product information · regulator = a regulator's assessment or decision, not research evidence · A = randomised human trial or meta-analysis · B = observational human study or case series · C = animal study · D = cell or laboratory study · E = not peer-reviewed

Notes

Efficacy was studied with the old formulation at a 2 mg daily dose; according to the label, 1.28 mg of Egrifta WR (tesamorelin) gives similar exposure [1]official.

The label does not cover weight loss: Egrifta WR (tesamorelin) is not indicated for weight management because its effect on weight is neutral [1]official.

What points the other way or is uncertain

The effect lasts only during treatment: when tesamorelin was switched to placebo after 26 weeks, abdominal visceral fat reaccumulated [3]A.

Before the Egrifta (tesamorelin) application was withdrawn, the EMA committee (CHMP) considered that the fat reduction had not been shown to bring a clinically meaningful health benefit and that the trial patients did not represent European HIV patients [4]regulator.

During 26 weeks of treatment IGF-1 rose above 2 standard deviation scores in 47% and above 3 in 36%, and hypersensitivity reactions occurred in 4% [1]official.

More on this

Read the research yourself: sources

  1. U.S. Food and Drug Administration / DailyMed. Egrifta WR (tesamorelin) for injection, prescribing information. Revised 3/2025 (DailyMed SPL version 2, published 3 Aug 2026), read 12 Oct 2026. DailyMed
  2. U.S. Food and Drug Administration / DailyMed. Egrifta SV (tesamorelin) for injection, prescribing information. Revised 2/2024 (DailyMed SPL version 9, published 31 Jul 2026), read 12 Oct 2026. DailyMed
  3. Falutz J, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008;22(14):1719-1728. PMID 18690162
  4. European Medicines Agency. Egrifta (tesamorelin): withdrawal of the marketing authorisation application, questions and answers (published 18 Jul 2012). EMA

The date is the "Revised: 3/2025" line of the Egrifta WR (tesamorelin) label on DailyMed. The Egrifta SV (tesamorelin) label shows 2/2024.

Content is general information about research, not medical advice. If you have symptoms, contact a healthcare professional.