How is tesamorelin dosed?
Tesamorelin is FDA-approved under two current brand names — Egrifta WR and Egrifta SV — for one specific indication. This page reads both current prescribing informations directly, the two Phase 3 trials both labels cite, and the adverse events reported at the approved dose.
Topic: Reading tesamorelin’s FDA prescribing information, for both current formulations
Audience: Anyone comparing a tesamorelin dose figure against its actual label or trial source
Reading time: 8–10 minutes
FDA-approved for one indication only
Tesamorelin is approved as Egrifta WR and Egrifta SV for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy — not for weight loss, general fat reduction, or anti-aging use. Both labels state it is not indicated for weight loss management and that long-term cardiovascular safety has not been established. Every figure on this page is read from the current prescribing information or a specific trial — not a recommendation for off-label use.
On this page
What tesamorelin is, and its one approved indication
Tesamorelin is a growth hormone-releasing factor (GHRF/GHRH) analog. It is approved by the FDA under two current brand names — Egrifta WR (11.6 mg/vial) and Egrifta SV (2 mg/vial) — for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Both labels state this explicitly as a limitation of use: tesamorelin is not indicated for weight loss management, and long-term cardiovascular safety has not been established.
Egrifta WR and Egrifta SV are explicitly stated as not substitutable — each formulation has its own dose, its own diluent, and its own reconstitution and storage instructions, read separately below. The tesamorelin profile covers the mechanism and broader research context in more depth; this page exists specifically to read both current labels’ dosing side by side.
What the two current labels specify
Both tables below are read directly from each product’s own current prescribing information on DailyMed — Egrifta WR and Egrifta SV are separate documents, separate approvals, and (per both labels) not substitutable for each other.
Egrifta WR (11.6 mg/vial formulation)
| Step | Figure | As specified by the label |
|---|---|---|
| Dose | 1.28 mg (0.16 mL of reconstituted solution) once daily | Subcutaneous injection in the abdomen, rotating sites; not the navel, scars, or bruises. |
| Reconstitution | 1 vial + 1.3 mL Bacteriostatic Water for Injection, USP | Swirl, do not shake. One reconstituted vial supplies 7 daily doses; discard 7 days after mixing. |
Egrifta SV (2 mg/vial formulation)
| Step | Figure | As specified by the label |
|---|---|---|
| Dose | 1.4 mg (0.35 mL of reconstituted solution) once daily | Subcutaneous injection in the abdomen, rotating sites; not the navel, scars, or bruises. |
| Reconstitution | 1 vial + 0.5 mL Sterile Water for Injection | Roll gently 30 seconds, do not shake. Administer immediately after reconstitution; discard any unused solution — do not freeze or refrigerate the reconstituted solution. |
Neither label states a missed-dose rule.
Searched in full, neither the Egrifta WR nor the Egrifta SV prescribing information contains missed-dose instructions of the kind Wegovy’s or Ozempic’s labels carry. This page states that absence rather than inferring a rule from another product’s label.
The Prof. Peptide dosage calculator converts between milligram figures and syringe units for a given reconstitution; it performs the arithmetic and does not set a schedule.
What the trials administered
Neither WR nor SV has its own dedicated efficacy trial. Both labels state that safety and effectiveness were established using the original EGRIFTA formulation (1 mg/vial, 2 mg once-daily dose) in the two trials below, and that WR’s and SV’s own approvals rest on demonstrated comparable bioavailability to that original 2 mg dose — a bridge, not a new efficacy trial at 1.28 mg or 1.4 mg specifically.
Both trials are graded against Prof. Peptide’s standing citation convention — a claim is attributed when it resolves to a named, checkable source. Both grade as attributed, cited directly in both current labels’ Clinical Studies section.
Study 1
NCT00123253Design: 26-week Main Phase, multicenter, randomized, double-blind, placebo-controlled trial in HIV-infected patients with lipodystrophy and excess abdominal fat, followed by a 26-week blinded Extension Phase.
Arms: 412 participants randomized to the original EGRIFTA (1 mg/vial formulation) 2 mg once daily (N=273) or placebo (N=137), subcutaneous injection.
Endpoint reported: Visceral adipose tissue (VAT) change at week 26 (CT scan, L4-L5 level, intent-to-treat with last observation carried forward): −27 cm² (EGRIFTA) versus +4 cm² (placebo), mean treatment difference −31 cm² (95% CI −39, −24); percent change −18% versus +2%, mean treatment difference −20 percentage points (95% CI −24, −15). IGF-1 rose by a mean of 107 ng/mL versus −15 ng/mL on placebo.
Attributed — cited directly in both Egrifta WR's and Egrifta SV's own Clinical Studies section (14), registered with a checkable NCT number independently confirmed against ClinicalTrials.gov.
Study 2
NCT00435136Design: 26-week Main Phase, multicenter, randomized, double-blind, placebo-controlled trial in HIV-infected patients with lipodystrophy and excess abdominal fat, followed by a 26-week blinded Extension Phase.
Arms: 404 participants randomized to the original EGRIFTA (1 mg/vial formulation) 2 mg once daily (N=270) or placebo (N=126), subcutaneous injection.
Endpoint reported: Visceral adipose tissue change at week 26: −21 cm² (EGRIFTA) versus −0 cm² (placebo), mean treatment difference −21 cm² (95% CI −29, −12); percent change −14% versus −2%, mean treatment difference −12 percentage points (95% CI −16, −7). IGF-1 rose by a mean of 108 ng/mL versus +3 ng/mL on placebo.
Attributed — cited directly in both current labels' Clinical Studies section, registered with a checkable NCT number independently confirmed against ClinicalTrials.gov.
Warnings and adverse events
Neither label carries a boxed warning — searched in full, no boxed warning section appears in either the Egrifta WR or Egrifta SV prescribing information. Both carry a Warnings and Precautions section covering: increased risk of neoplasms (preexisting malignancy should be inactive and treatment complete before starting; discontinue if malignancy recurs); elevated IGF-1 (monitor during therapy; consider discontinuing with persistent elevation); fluid retention (edema, arthralgia, carpal tunnel syndrome); glucose intolerance or diabetes mellitus (increased risk of developing diabetes versus placebo, hazard ratio 3.3); hypersensitivity reactions; and injection site reactions.
Table 1 of the label (combined across both pivotal studies) reports adverse reactions occurring in 1% or more of tesamorelin-treated patients and more frequently than on placebo, during the 26-week placebo-controlled phase:
| Adverse reaction | Placebo (N=263) | Tesamorelin (N=543) |
|---|---|---|
| Injection site reaction (combined) | 6% | 17% |
| Arthralgia | 11% | 13% |
| Pain in extremity | 5% | 6% |
| Myalgia | 2% | 6% |
| Edema peripheral | 2% | 6% |
| Paresthesia | 2% | 5% |
| Hypoesthesia | 2% | 4% |
| Rash | 2% | 4% |
N=543 reflects the 740 tesamorelin-treated patients across all trials, of whom 543 received tesamorelin during the initial 26-week placebo-controlled phase — matching the figure both labels cite.
Is there a community-reported dose?
Mostly, it mirrors the label rather than diverging from it. Off-label and wellness-context tesamorelin dosing commonly cites the same 1.28–2 mg once-daily figure the labels themselves specify — not an independent community finding distinct from the approved dose.
One genuine divergence was found and is reported here rather than folded into the label schedule above: some wellness sources describe a 5-days-on, 2-days-off weekly cycle. Neither Egrifta label states that pattern — both describe continuous once-daily use, with the label instructing risk/benefit to be reassessed at 26 weeks if visceral fat has not been reduced.
Compounding and research-grade tesamorelin
Tesamorelin’s compounding-eligibility question is structurally different from a compound with no approved product.
Section 503A of the Federal Food, Drug, and Cosmetic Act treats a bulk drug substance as eligible for compounding if it complies with a USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA’s 503A bulks list. Tesamorelin IS a component of two FDA-approved drugs — Egrifta WR and Egrifta SV — which satisfies that second condition directly, from the label itself. That is a statement about eligibility, not a claim that compounding tesamorelin is therefore routine or unrestricted: 503A’s own operative conditions — a documented drug shortage, or a prescriber-documented clinical difference for a specific patient — govern when a compounding pharmacy may actually rely on that eligibility, and this page has not verified whether either condition currently applies to tesamorelin.
Research-grade tesamorelin, of the kind sold by the vendors Prof. Peptide tracks elsewhere on this site, is neither the branded Egrifta product nor a verified pharmacy-compounded version of it. It is sold labeled for laboratory research use, not for human administration, and it is not dispensed against a prescription.
FAQ
Is tesamorelin FDA-approved?
What is the approved Egrifta dosage?
Are Egrifta WR and Egrifta SV backed by their own separate trials?
What happens if a dose is missed?
Does tesamorelin carry a boxed warning?
Is there a commonly reported tesamorelin dosing protocol outside the label?
Can tesamorelin legally be compounded?
What does Prof. Peptide's own research-grade tesamorelin fall under, then?
References
- Theratechnologies Inc. EGRIFTA WR (tesamorelin) for injection — prescribing information. DailyMed, setid 839334d3-8c1d-4c26-9036-2ab524a6ea75. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
- Theratechnologies Inc. EGRIFTA SV (tesamorelin) for injection — prescribing information. DailyMed, setid 3d783378-b02d-4f19-99dd-0fc91a042224. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
- ClinicalTrials.gov. Study 1, NCT00123253. https://clinicaltrials.gov/study/NCT00123253
- ClinicalTrials.gov. Study 2, NCT00435136. https://clinicaltrials.gov/study/NCT00435136
- U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
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