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Evidence review

Tesamorelin Dosing: What the Egrifta FDA Label Actually Specifies

Tesamorelin's dose is on a real FDA label — 1.4 mg (Egrifta SV) or 1.28 mg (Egrifta WR), daily, for a specific HIV indication. Here's exactly what it says.

Written by David ChenClinical Evidence & Regulatory Editor

Roughly 12,000 searches a month ask some version of "tesamorelin dosage," and unlike sermorelin — our companion article covers why sermorelin currently has no FDA label to quote at all — tesamorelin actually has one. Two, in fact. Egrifta SV and Egrifta WR are both current, FDA-approved products, each with its own dosing instructions, and this page reports what those labels say rather than what a wellness clinic's dosing chart claims.

One fact worth stating before any number: both labels approve tesamorelin for exactly one indication — reduction of excess abdominal fat in HIV-infected adults with lipodystrophy — and both state plainly that tesamorelin "is not indicated for weight loss management as it has a weight neutral effect." If you found this page searching for a general body-composition, longevity, or anti-aging dose, the label you're about to read wasn't written for that use.

The two formulations are not the same drug math — and are not substitutable

Theratechnologies sells tesamorelin under two brand names, and the labels are explicit that switching between them isn't a matter of just doing the arithmetic: "EGRIFTA WR and EGRIFTA SV are not substitutable2." Each has its own vial strength, its own diluent, its own reconstituted concentration, and its own dose.

Two approved products, two different numbers

Egrifta SVEgrifta WR
Vial strength2 mg lyophilized powder, single-dose vial11.6 mg lyophilized powder, single-patient-use vial
Diluent0.5 mL Sterile Water for Injection1.3 mL Bacteriostatic Water for Injection
Reconstituted concentration4 mg/mL8 mg/mL
Daily dose1.4 mg (0.35 mL)1.28 mg (0.16 mL)
Vial useSingle-use — discard unused solution immediately after each doseMulti-dose — one vial supplies 7 consecutive daily doses, discarded 7 days after mixing
Route / frequencySubcutaneous, once daily, into the abdomenSubcutaneous, once daily, into the abdomen
Read directly off each product's live DailyMed structured product label, sections 2 and 3. The two are explicitly stated as not substitutable.

Egrifta SV ships as 2 mg of lyophilized powder in a single-dose vial. Reconstitute it with 0.5 mL of Sterile Water for Injection — the label specifies that diluent by name — which yields a 4 mg/mL solution. The dose is 1.4 mg, drawn as 0.35 mL of that reconstituted solution, injected subcutaneously once daily. Administer it immediately after reconstitution; the label is explicit that any unused solution is discarded — this is a single-use vial, not a multi-dose one, and it is not frozen or refrigerated after mixing1.

Egrifta WR ships as 11.6 mg of lyophilized powder in a single-patient-use vial. Reconstitute it with 1.3 mL of Bacteriostatic Water for Injection — a different diluent than Egrifta SV uses — yielding an 8 mg/mL solution. The dose is 1.28 mg, drawn as 0.16 mL of that reconstituted solution, injected subcutaneously once daily. The handling model is genuinely different here: one reconstituted Egrifta WR vial supplies seven consecutive daily doses, stored at room temperature and discarded seven days after mixing, rather than a fresh single-use vial every day2.

Both labels give the same injection instructions regardless of formulation: inject into the abdomen, rotate sites to different areas each time, and never inject into scar tissue, bruises, or the navel12.

Why 1.4 mg and 1.28 mg are actually the same clinical dose

Those two numbers look like different doses, and in the strict sense that a syringe holds a different quantity each way, they are. But they trace back to the same underlying trial dose. The pivotal Phase 3 program that won tesamorelin its approval — 806 HIV patients pooled across two studies, randomized 2:1 to tesamorelin or placebo — used tesamorelin 2 mg subcutaneously once daily, which was the dose delivered by the older 1 mg-per-vial formulation (two vials reconstituted and combined to reach 2 mg)4. When Theratechnologies later reformulated the drug into higher-concentration single vials (first Egrifta WR's 11.6 mg vial, then Egrifta SV's 2 mg vial), the company's own bioequivalence work set the new doses — 1.28 mg and 1.4 mg respectively — to deliver the same tesamorelin exposure the original 2 mg trial dose produced, not a new dose chosen independently. The number on the syringe changed with the formulation; the pharmacological dose the label is built around did not.

No missed-dose provision — a real gap, not an oversight to guess around

Tirzepatide's FDA label states exactly what to do about a missed dose (administer within 4 days, otherwise skip and resume normally) and how far apart two doses can be moved (at least 3 days). Egrifta's own label has no equivalent language — a direct search of both current SPL documents for "missed dose" returns zero results in either. That's not a secret the labels are hiding; it reflects that tesamorelin's approved use is a once-daily injection maintained over months, evaluated by whether visceral fat responds, rather than a titrated ladder where the timing of any single dose changes the outcome the way it can for a GLP-1. Anyone offering a specific missed-dose rule for tesamorelin is not reading it off the label, because the label doesn't have one.

What the label states plainly, and what it doesn't address at all

  • Approved for exactly one indication: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy — both labels state it is "not indicated for weight loss management as it has a weight neutral effect."
  • Egrifta WR and Egrifta SV are explicitly stated as not substitutable — the dose and reconstitution steps differ by formulation.
  • Both labels' 1.4 mg / 1.28 mg doses trace back to the same 2 mg-per-day dose used in the pivotal 806-patient Phase 3 trial program, adjusted for the newer formulations' concentration.
  • Neither current label contains a missed-dose instruction or a rule for changing the injection day — a real gap, not an omission from this article.
  • The label describes the approved product's own vial strengths and reconstitution steps — it does not set a dose for a compounded vial, which may be an entirely different concentration.

What a compounded tesamorelin dose is actually measured against

Neither Egrifta SV's nor Egrifta WR's approved dosing describes what a compounding pharmacy sells under the tesamorelin name — a compounded vial is not FDA-reviewed for identity or concentration before sale, and it may use an entirely different strength than either approved product. What the label does supply is the reference arithmetic: volume (mL) = dose (mg) ÷ concentration (mg/mL), exactly the same relationship our tirzepatide dosing page works through for that molecule. If you already have a prescribed tesamorelin dose and a vial with a stated concentration, our tesamorelin reconstitution calculator runs that arithmetic on the numbers you enter — it does not tell you what dose is right for you, and it does not verify that the vial contains what its label claims.

Who this page's board tie-in actually is

This site tracks providers for exactly one growth-hormone-axis compound: our sermorelin provider rankings. Tesamorelin is not sold by any provider on that roster, and it shouldn't be presented as if it were — tesamorelin's only approved use is a specific HIV-related condition, not general wellness, and that limit doesn't disappear because a telehealth site markets it alongside sermorelin. If you're comparing tesamorelin to sermorelin specifically, our head-to-head on what the evidence and FDA history actually show covers that directly. If the comparison you're actually making is broader — which growth-hormone secretagogue has the most support behind it — our ipamorelin vs. sermorelin comparison and our MK-677 vs. sermorelin comparison cover the other two compounds most often marketed alongside it.

The bottom line

Egrifta SV's dose is 1.4 mg (0.35 mL of a 4 mg/mL reconstituted solution); Egrifta WR's dose is 1.28 mg (0.16 mL of an 8 mg/mL solution good for seven days once mixed) — different numbers because the products are formulated differently, tracing back to the same 2 mg trial dose that won tesamorelin its approval. Both are injected once daily into the abdomen. Neither label specifies what to do about a missed dose. And both labels approve tesamorelin for exactly one thing: reducing excess abdominal fat in HIV-infected adults with lipodystrophy — not general anti-aging, not weight loss, and not the wellness use it's frequently sold for.

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Also worth knowing

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See Strut Health

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Frequently asked questions

What is the FDA-approved tesamorelin dosage?

It depends on the formulation. Egrifta SV's dose is 1.4 mg (0.35 mL of a reconstituted 4 mg/mL solution), injected subcutaneously once daily. Egrifta WR's dose is 1.28 mg (0.16 mL of a reconstituted 8 mg/mL solution), also once daily. The label states the two products are not substitutable. Both doses trace back to the same 2 mg-per-day dose used in tesamorelin's pivotal Phase 3 trials, adjusted for each formulation's concentration.

What happens if I miss a dose of tesamorelin?

Neither current FDA label — Egrifta SV's or Egrifta WR's — contains a missed-dose instruction. A direct search of both live label documents for that language returns nothing. Unlike tirzepatide's label, which specifies a 4-day window for a missed dose, tesamorelin's approved labeling simply doesn't address the question.

Are Egrifta SV and Egrifta WR dosed the same way?

No. They use different vial strengths, different diluents (Sterile Water for Injection vs. Bacteriostatic Water for Injection), different reconstituted concentrations, and different resulting doses in milligrams and milliliters. The label states explicitly that the two are not substitutable for each other.

Is tesamorelin's dosage approved for weight loss or anti-aging?

No. Both current labels approve tesamorelin for exactly one use — reduction of excess abdominal fat in HIV-infected adults with lipodystrophy — and both state directly that it is not indicated for weight loss management because it has a weight-neutral effect. Neither label addresses anti-aging or general body-composition use in adults without that diagnosis.

References

  1. Theratechnologies Inc. (2026). EGRIFTA SV (tesamorelin) for injection full prescribing information — sections 1 Indications and Usage, 2.1 Recommended Dose and Important Administration Instructions, 2.2 Reconstitution Procedure, and 3 Dosage Forms and Strengths. DailyMed — U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
  2. Theratechnologies Inc. (2026). EGRIFTA WR (tesamorelin) for injection full prescribing information — sections 1 Indications and Usage, 2.1 Recommended Dosage and Administration, 2.2 Reconstitution Procedure, and 3 Dosage Forms and Strengths, including the statement that EGRIFTA WR and EGRIFTA SV are not substitutable. DailyMed — U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
  3. U.S. Food and Drug Administration (2026). Drugs@FDA record for EGRIFTA (tesamorelin acetate), BLA 022505, sponsor Theratechnologies — original approval November 10, 2010. openFDA — Drugs@FDA public API. https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:EGRIFTA&limit=10
  4. Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S (2010). Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. The Journal of Clinical Endocrinology & Metabolism. https://pubmed.ncbi.nlm.nih.gov/20554713/

Medical disclaimer: This content is for general educational purposes only and is not medical advice, diagnosis, or treatment. Always consult a licensed healthcare professional before starting, stopping, or changing any treatment.