Tesamorelin Dosage Guide: FDA Label, Trial Evidence and Reconstitution

Tesamorelin is the only FDA-approved GHRH peptide. It stimulates the pituitary to release the body's own growth hormone in a pulsatile pattern rather than supplying growth hormone directly. Its approval is specific and narrow: reduction of excess visceral fat in adults with HIV-associated lipodystrophy, established in placebo-controlled Phase III trials at 2 mg subcutaneously once daily. Egrifta SV (1.4 mg delivered dose) and Egrifta WR (1.28 mg delivered dose) are newer, differently concentrated versions of the same approved indication. Research-use lyophilized vials at 2, 5 or 10 mg are not the approved product, and any use outside HIV-associated lipodystrophy is off-label.

The supplied source reports that research vials are most commonly dosed at 2 mg subcutaneously once daily to match the original legacy Egrifta Phase III protocol, with no titration, injected in the abdomen. It separately reports the current label doses: 1.4 mg once daily for Egrifta SV (drawn as 0.35 mL after reconstitution with 0.5 mL diluent) and 1.28 mg once daily for Egrifta WR (drawn as 0.16 mL after weekly reconstitution with 1.45 mL bacteriostatic water).

Unlike most peptides discussed on this site, tesamorelin does not use a slow titration; the label and Phase III trials started patients at the full dose on day one. Research-vial dosing of 2 mg/day mirrors the original legacy Egrifta trial dose, but research vials themselves are not the FDA-approved product and have not been independently reviewed for quality or labeling accuracy.

Neutral research-material planning only. This does not establish an appropriate amount or route.

Routes and amounts are not interchangeable unless a verified study explicitly establishes a conversion.

Published study values describe those studies. Community-reported values are not validated dosing recommendations.

Concentration: 2.5 mg/mL

1. 1.Confirm the exact quantity printed on the vial label.
2. 2.For research vials, choose and record the bacteriostatic water volume; a 10 mg vial in 2 mL gives 5 mg/mL.
3. 3.For Egrifta SV, use only the diluent supplied with the product and inject immediately after mixing, per label.
4. 4.For Egrifta WR, reconstitute the 11.6 mg vial with 1.45 mL bacteriostatic water once weekly.
5. 5.Clean the stopper with an alcohol swab before each draw.
6. 6.Add liquid slowly down the vial wall; swirl gently and never shake.
7. 7.Inspect for cloudiness, discoloration or particles and discard anything that is not clear.
8. 8.Label the vial with the calculated concentration and preparation date; refrigerate as directed by the formulation.

Reconstitution does not establish identity, purity, sterility, stability, or an appropriate amount.

• Falutz et al., New England Journal of Medicine (2007): a randomized, placebo-controlled trial of tesamorelin 2 mg SC daily in HIV-associated lipodystrophy reported a 15–18% reduction in visceral adipose tissue over 26 weeks.
• Stanley et al. and subsequent pooled Phase III extension data (2014) supported sustained visceral fat reduction with continued therapy through 52 weeks.
• Trial data show visceral fat returns toward baseline after discontinuation, indicating that sustained therapy is generally needed to maintain results.
• Tesamorelin has also been studied in separate NAFLD/liver-fat contexts with up to 12-month exposure patterns.

This is an evidence-gap and precaution list, not an approved prescribing label.