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TsApproved drug

Tesamorelin protocol

Tesamorelin is a copy of the body's growth-hormone-releasing hormone. In the US it is an approved medicine to reduce extra belly fat in adults with HIV and lipodystrophy.

Approved in the US - Egrifta SV and Egrifta WR (HIV-related belly fat)The label says it is not for weight loss, and long-term heart safety is not established
ProtocolMixingResultsSide effectsHow it worksSources

The protocol at a glance

The US labels set one daily injection into the belly skin: 1.4 mg for Egrifta SV or 1.28 mg for Egrifta WR. The two products are not interchangeable. The big trials used 2 mg a day of an older formulation for 26 weeks.

Product or studyDaily amount (one injection a day)
Egrifta SV (2 mg vial)1.4 mg
Egrifta WR (11.6 mg vial; one vial lasts 7 days)1.28 mg
Pivotal trials (older 1 mg-per-vial product), 26 weeks2 mg

From the US prescribing information for Egrifta SV and Egrifta WR (DailyMed). WR and SV are not substitutable because strength, dose and mixing differ, so follow the label for the product you have. The calculator uses the SV vial (2 mg mixed in 0.5 mL gives 1.4 mg in 0.35 mL).

Community reports

Community reports commonly describe 1-2 mg a day, often citing the 2 mg used in the early trials.

What people say they do, collected from community discussions. Not tested in a trial; shown so you can compare it with the evidence above.

Mixing calculator

Enter the vial size, the water you add and the amount you want to draw; it gives the mark on a 100-unit (1 mL) insulin syringe.

Draw to – units

What the trials found

Two placebo-controlled trials of about 400 adults each with HIV lipodystrophy, 26 weeks, 2 mg a day. Measured: change in deep belly fat (visceral fat):

-18%Tesamorelin, study 1 (273 people)
+2%Placebo, study 1 (137 people)
-14%Tesamorelin, study 2 (270 people)
-2%Placebo, study 2 (126 people)

US prescribing information, Egrifta SV and WR (DailyMed). In weeks 26-52, people switched to placebo regained belly fat (about +25 and +24 cm2), so the effect needs continued use.

Side effects

  • Most common (26-week trials, tesamorelin vs placebo): injection site reactions 17% vs 6%, joint pain 13% vs 11%, muscle pain 6% vs 2%, swelling in arms or legs 6% vs 2%.
  • Allergic reactions occurred in 4% of people.
  • It raises IGF-1, so the label calls for IGF-1 monitoring.
  • Long-term heart safety has not been established (label).

How it works

GHRH receptor

It copies the natural growth-hormone-releasing hormone, so the pituitary gland releases more of your own growth hormone and IGF-1 goes up.

Sources

  • EGRIFTA WR (tesamorelin) US prescribing information, DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75
  • EGRIFTA SV (tesamorelin) US prescribing information, DailyMed setid 3d783378-b02d-4f19-99dd-0fc91a042224