What is the FDA-approved tesamorelin dose?

The Egrifta label specifies 2 mg injected subcutaneously once a day into the abdomen, with injection sites rotated. It is approved only to reduce excess abdominal fat in adults with HIV-associated lipodystrophy, and it is explicitly not indicated for general weight loss.

Is tesamorelin taken at a particular time of day?

The label does not mandate a specific time; once daily is the schedule. Because growth hormone release peaks in sleep, some clinicians and off-label protocols favor bedtime administration, but this is preference rather than a labeled requirement.

How is off-label tesamorelin dosing different?

Off-label and research protocols sometimes use 1–2 mg/day in time-limited cycles for general visceral fat or other goals. These uses are investigational, not FDA-approved, and any dosing outside the HIV-lipodystrophy indication should be supervised by a prescriber.

Dosage Guide · FDA-approved drug

Tesamorelin Dosage: What Egrifta's Label Says

Last updated May 19, 2026 · Reviewed by Grey Peptides Editorial Board · ✓ Based on FDA labeling

← Tesamorelin encyclopedia entry · See also: Sermorelin dosage · CJC-1295 dosage

📋 Key takeaways

Tesamorelin is an FDA-approved prescription medicine sold as Egrifta (and the newer Egrifta SV and Egrifta WR formulations). Its one approved use is the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy — it is explicitly not a weight-loss drug.

The labeled dose is simple and fixed: 2 mg subcutaneously once daily into the abdomen. There is no titration ramp the way GLP-1 drugs have. The product is supplied as a powder that must be reconstituted before each dose.

This page summarizes the label for education. Anything beyond the HIV-lipodystrophy indication — the "anti-aging" and visceral-fat uses discussed online — is off-label and investigational, and should be overseen by a clinician.

The short version

Tesamorelin is a synthetic analog of growth-hormone-releasing hormone (GHRH) — it preserves the full 44–amino-acid GHRH sequence with a chemical modification that resists rapid enzymatic breakdown, so it stimulates the pituitary to release growth hormone in a roughly natural, pulsatile pattern. Unlike the GLP-1 drugs, its approved schedule is a single fixed dose with no step-up. The interesting tension in tesamorelin is that its approved indication is narrow while its off-label following is broad, so reading "a dose" correctly depends on knowing which context you are in.

The FDA-labeled schedule

Per the Egrifta prescribing information, the dose is 2 mg injected subcutaneously once daily. The recommended injection site is the abdomen, with sites rotated and scar tissue, bruises, and the navel avoided. The medicine is a lyophilized powder that is reconstituted before administration; the original Egrifta and Egrifta SV use a 2 mg/vial preparation, while the concentrated Egrifta WR formulation (approved in 2025) simplifies preparation and is set to replace SV.

Parameter	Label specification
Dose	2 mg once daily
Route	Subcutaneous, abdomen (rotate sites)
Titration	None — fixed dose
Indication	Excess abdominal fat in HIV-associated lipodystrophy
Not indicated for	Weight-loss management

In the pivotal Phase 3 program, this dose produced roughly a 15–20% reduction in visceral adipose tissue over about 26 weeks, and later research explored effects on liver fat in NAFLD. Benefit is generally re-evaluated after several months, since the label notes effects reverse when treatment stops.

Reconstitution and administration

Because tesamorelin is supplied as a powder, each dose involves reconstituting with the provided diluent and drawing up the correct volume — the exact steps differ between the 2 mg/vial (Egrifta, Egrifta SV) and concentrated (Egrifta WR) formulations, which is precisely why the label tells patients not to mix instructions between products. If you are working through the arithmetic conceptually, our Reconstitution Calculator converts vial strength and diluent volume into an exact syringe draw, and the Mixing & Administration Guide covers sterile technique. For the prescription product, always follow the specific leaflet that comes with your formulation.

Where off-label use departs from the label

Most online interest in tesamorelin is not about HIV lipodystrophy — it is about general visceral fat, body composition, and even cognition in aging, none of which are approved indications. Off-label protocols often cite 1–2 mg/day in 8–12 week cycles. It is important to be clear-eyed here: those uses are investigational, the long-term cardiovascular safety even in the approved population is described by the label as not established, and "research-grade" tesamorelin sold outside pharmacies is not the FDA-approved product. The verified-safe path is the approved medicine, prescribed and monitored.

Frequently asked questions

Does tesamorelin need to be cycled?

The label describes continuous daily use with periodic re-evaluation of benefit, not fixed cycles. The "cycling" idea comes from off-label practice, not the prescribing information.

Is it the same as HGH?

No. Tesamorelin prompts your own pituitary to release growth hormone in pulses, whereas recombinant HGH supplies the hormone directly at constant levels. That difference is part of why the GHRH-analog approach is often described as more physiologic.

Can it be used for weight loss?

The label specifically says it is not indicated for weight-loss management; it is weight-neutral and targets visceral fat in a specific population.

Sources

Egrifta (tesamorelin for injection) U.S. Prescribing Information — FDA, initial approval 2010; Egrifta SV and Egrifta WR labeling updates.
Falutz J, et al. "Metabolic effects of a growth hormone–releasing factor in patients with HIV." N Engl J Med. 2007;357:2359–2370.
FDA approval of Egrifta WR (concentrated F8 tesamorelin), March 2025.

Medical disclaimer: Education only, not medical advice. The labeled dose applies to the FDA-approved indication; other uses are off-label and investigational. Dosing is individualized by a prescriber. Consult a licensed clinician.