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Growth Hormone & Anti-Ageing

Tesamorelin Dosage: Label Doses, Timing and Trial Results

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Tesamorelin dosage chart overlay beside a vial, showing the daily dose on a dark matte black surface

What is the tesamorelin dosage on the FDA label?

The tesamorelin dosage on the FDA label is one shot under the skin each day. That is 2 mg for the original Egrifta, 1.4 mg for Egrifta SV and 1.28 mg for Egrifta WR. It is approved only to cut excess belly fat in adults with HIV and lipodystrophy. No dose is established for any other use.

Lipodystrophy means the body stores fat in the wrong places. In people with HIV, fat can build up deep in the belly, around the organs. That deep fat is called visceral fat. Tesamorelin was approved in 2010 to reduce it. FDA Egrifta Original Label 2010

Tesamorelin is a growth hormone releasing hormone analog, the label says. GHRH is the short form, and I'll use it from here. An analog is a lab-made copy with small changes. It does not work like a growth hormone shot. It signals your pituitary gland instead, and the gland releases your own growth hormone. DailyMed Egrifta SV 2024

This guide sets out the doses on the three labels, how the vials are mixed, and what the trials found. It also covers side effects, the lab tests the label names, and what is known about stacking. Every number here traces back to a label or a named study. Nothing here is medical advice. Always work with a qualified clinician before making changes to your health protocol.

Affiliate disclosure: This post links to no supplier directly. It links to our sources page, which lists suppliers, and some links there may earn us a commission.

What is tesamorelin, and how does a tesamorelin dosage act in the body?

Tesamorelin is the 44-amino acid sequence of human GHRH, made in a lab. A small fatty chain, called a hexenoyl group, is attached at one end. The label describes it this way. DailyMed Egrifta SV 2024

It stimulates growth hormone release, which then raises IGF-1. IGF-1 is a growth factor your liver makes in response to growth hormone. The label reports no clinically significant change in other pituitary hormones in the trials. DailyMed Egrifta SV 2024

It clears from the blood fast. Half-life is the time for half a dose to leave the blood. The 2010 label gave 26 minutes in healthy people and 38 minutes in people with HIV. The Egrifta SV label gives 8 minutes for a 1.4 mg dose. The Egrifta WR label gives 11 minutes. FDA Egrifta Original Label 2010 DailyMed Egrifta SV 2024 FDA Egrifta WR Label 2025.

Only a small share of a shot reaches the blood. The label puts it at under 4% for a 2 mg dose in healthy adults. Each label sets the dose for its own product. DailyMed Egrifta SV 2024

For the mechanism in full, read the tesamorelin peptide hub first. Wider background sits in our complete tesamorelin guide. This page stays on the numbers.

What tesamorelin dosage per day does the FDA prescribing information give?

The approved dose depends on the formulation. Original Egrifta is 2 mg daily. Egrifta SV is 1.4 mg daily. Egrifta WR is 1.28 mg daily. All three are once-daily shots under the skin. FDA Egrifta Original Label 2010 FDA Egrifta SV Label 2024 FDA Egrifta WR Label 2025.

The first approval in 2010 used 2 mg daily. The Egrifta SV label says 1.4 mg of Egrifta SV gives similar levels in the blood to 2 mg of the original. FDA Egrifta Original Label 2010 DailyMed Egrifta SV 2024.

Egrifta WR comes as an 11.6 mg vial. Once mixed, one vial gives daily doses for 7 days. Its label sets the dose at 1.28 mg once daily. It also says Egrifta WR and Egrifta SV are not substitutable. FDA Egrifta WR Label 2025

One thing to be straight about. The FDA nod covers HIV-linked lipodystrophy, and nothing wider. The label also says it is not for weight loss, because its effect on weight is neutral. Off-label use for plain body composition has only a small trial base outside HIV. DailyMed Egrifta SV 2024

A 2012 review of the trials reached the same view. It found limited data to support off-label uses. Spooner and Olin 2012

Tesamorelin dosage chart: what dose does each product use?

The doses below are the label doses. Each is one shot a day under the skin of the belly. The trials outside the label on this page used 1 mg or 2 mg a day. The chart does not cover bodybuilding, men or women as separate goals, because no label or trial sets a dose for them.

ProductVialMixed withStrength once mixedDaily dose
Egrifta, first approved 20101 mgSterile water1 mg/mL2 mg
Egrifta SV2 mg0.5 mL sterile water4 mg/mL1.4 mg, which is 0.35 mL
Egrifta WR11.6 mg1.3 mL bacteriostatic water8 mg/mL1.28 mg, which is 0.16 mL

The labels give one adult dose. They do not change it for men or women. In the two main trials, 84% to 86% of the people were men. DailyMed Egrifta SV 2024

A tesamorelin 10 mg vial is not an approved product. So no label gives a mixing volume or dose for one. The labels also give each dose as a volume in mL, not in syringe units.

The pooled Phase 3 analysis of 806 patients looked at who responded best. Phase 3 means the large trials a drug needs for approval. Three factors made a response more likely: metabolic syndrome, triglycerides above 1.7 mmol/L, and white race. Mangili et al. 2015

Metabolic syndrome is a cluster of risk markers, such as high blood pressure and high blood sugar. Triglycerides are the fats carried in your blood. None of these factors changed the dose, which stayed at 2 mg in every group given tesamorelin. Mangili et al. 2015

Is there a best time for the tesamorelin dosage per day?

Once a day, with no set time. The Egrifta SV label gives no time of day and says nothing about meals. FDA Egrifta SV Label 2024.

Egrifta SV must be used as soon as it is mixed. Any unused solution is thrown away, and it must not be frozen or chilled. One Egrifta WR vial, once mixed, covers 7 daily doses. FDA Egrifta SV Label 2024 FDA Egrifta WR Label 2025.

Bedtime or fasted dosing is not on any label, and no trial on this page tested it. The published abstracts of both main trials give the dose, 2 mg a day under the skin, and no time of day. Falutz 2007 Falutz 2010.

How fast does the tesamorelin dosage for belly fat work?

Results were measured at 26 weeks. The label reports two trials of 2 mg a day. Visceral fat fell by 18% and 14% on average. On placebo, a dummy shot, it changed by +2% and -2%. DailyMed Egrifta SV 2024

The label reports these as model-based averages from CT scans. A CT scan is a detailed X-ray that can measure fat inside the belly. The label also reports trunk fat, which fell by 1.0 kg and 0.8 kg. Lean body mass rose by 1.3 kg and 1.2 kg. DailyMed Egrifta SV 2024.

Both main trials were also published. In the 412-patient trial, visceral fat fell 15.2% on tesamorelin and rose 5.0% on placebo at 26 weeks. In the 404-patient trial, it fell 10.9% against 0.6% on placebo at 6 months. In patients who stayed on it for 12 months, the fall was about 18%. Falutz 2007 Falutz 2010.

Stop, and the fat comes back. In the second 26 weeks, some patients were switched to placebo. Their visceral fat rose by 22% and 16% in the two trials. Those who stayed on tesamorelin held their loss. DailyMed Egrifta SV 2024

That last point is the one to sit with. A 2011 review called the effect "transient". The loss held only in patients who stayed on it. The two main trials ran for 52 weeks in all, a 26-week main phase and a 26-week extension. Bedimo 2011 FDA Egrifta Original Label 2010.

  • Liver fat: A 6-month trial of 50 people with HIV found lower visceral fat and modest drops in liver fat. Stanley et al. 2014
  • Liver enzymes: In Phase 3 patients who started with raised liver enzymes, responders had larger drops in ALT and AST. These are two liver enzymes measured in blood tests. A responder lost at least 8% of visceral fat. Fourman et al. 2017

A 2023 meeting abstract looked at people on INSTI therapy, a modern class of HIV drug. It re-analysed 39 of them from a 61-person liver fat trial. After 12 months, visceral fat fell 8.3% on tesamorelin and rose 10.8% on placebo. McLaughlin et al. 2023

That liver fat trial in HIV, registered as NCT02196831, gave 2 mg under the skin daily for 12 months. Its protocol planned 60 participants. It built in a one-time cut to 1 mg for anyone whose IGF-1 "exceeds 3 standard deviations above the mean". A standard deviation measures how far results usually spread from the average. Tesamorelin Trial Protocol, Massachusetts General Hospital

A 6-month open-label phase followed, "during which all study participants receive tesamorelin". Open-label means everyone knows what they are taking. Tesamorelin Trial Protocol, Massachusetts General Hospital

Is there a tesamorelin dosage cycle?

No tested tesamorelin dosage cycle exists. The main trials ran 26 weeks, then a further 26 weeks, with no break. No trial on this page tested on-and-off cycles, rests, or a five-days-on pattern. FDA Egrifta Original Label 2010

What the trials do show is the cost of stopping. Visceral fat came back in the patients switched to placebo. A 2011 review said stopping "resulted in the reaccumulation" of visceral fat. Dhillon 2011

The label also gives a stopping point. It says to weigh the risks and benefits of carrying on in patients whose visceral fat has not fallen. DailyMed Egrifta SV 2024

IGF-1 is the other checkpoint the label names. The label says to monitor IGF-1 and consider stopping if IGF-1 stays persistently high (for example above 3 SDS). FDA Egrifta WR Label 2025

SDS stands for standard deviation score. It measures how far a result sits from the average for your age and sex.

How do you mix the vial and draw the tesamorelin dose?

The Egrifta SV label sets out these steps, using only the sterile water supplied in the box. Egrifta SV takes 0.5 mL of sterile water, which gives 4 mg/mL. FDA Egrifta SV Label 2024

The label's steps, in order:

  1. 0.5 mL of the supplied sterile water goes into one 2 mg vial.
  2. The vial is rolled gently in the hands for 30 seconds, never shaken.
  3. The solution is used only if it is clear, colourless and free of floating bits.
  4. The dose is 0.35 mL, which holds 1.4 mg.
  5. It is injected straight away, and any unused solution and water is thrown away.

Egrifta WR is different. Its label uses 1.3 mL of the bacteriostatic water supplied, which gives 8 mg/mL. The daily dose is 0.16 mL, and one vial lasts 7 days. FDA Egrifta WR Label 2025

The label says to inject into the abdomen. It says to rotate shots to different areas of the belly, and to avoid the navel, scar tissue and bruises. Rotating sites cuts down on reactions at the needle site. FDA Egrifta SV Label 2024

For general technique, see our peptide reconstitution guide. The peptide reconstitution chart shows the arithmetic for mg/mL. For Egrifta itself, the label's own steps apply.

What side effects did trials record at the tesamorelin dose?

The label counts reactions at the needle site first. Over the first 26 weeks, 25% had one on Egrifta, against 14% on placebo. These included redness, itching, pain, irritation and bruising. DailyMed Egrifta SV 2024

The 2010 label broke them down. At the needle site, redness hit 8.5% against 2.7% on placebo, and itching 7.6% against 0.8%. Other effects were counted apart from these. Puffy hands and feet came in at 6.1% against 2.3%. Joint pain and carpal tunnel signs showed up too. FDA Egrifta Original Label 2010

Carpal tunnel syndrome is a trapped nerve in the wrist that causes tingling and numbness. Allergic-type reactions, such as rash and hives, occurred in 4% of patients. DailyMed Egrifta SV 2024.

The metabolic risks are the ones to watch:

  • Blood sugar: HbA1c of 6.5% or more showed up in 5% of patients on Egrifta. On placebo it was 1%. The label gives a hazard odds ratio of 3.3. That measures how much higher the odds of it were than on placebo. HbA1c is your three-month blood sugar mean. The label says to check glucose before starting and during treatment. DailyMed Egrifta SV 2024
  • IGF-1 climbing: At 26 weeks, 47% had IGF-1 more than 2 standard deviations above the average for their age. At that point, 36% were more than 3 above it. Among those who stayed on it for 52 weeks, 34% were more than 2 above it and 23% more than 3. The label says the effects of long-term high IGF-1 are unknown. DailyMed Egrifta SV 2024
  • Heart: The label says, "Long-term cardiovascular safety of EGRIFTA SV has not been established." Cardiovascular means the heart and blood vessels. DailyMed Egrifta SV 2024
  • Antibodies: By 26 weeks, 50% of patients made anti-tesamorelin antibodies, and 47% by 52 weeks. About 60% of those also reacted to your own GHRH. Patients with and without them had similar drops in visceral fat. DailyMed Egrifta SV 2024
  • Fluid: Swelling, achy joints and carpal tunnel are linked to growth hormone. The label says they are either short-lived or resolve once treatment stops. DailyMed Egrifta SV 2024

The label lists four groups who must not use it. They are people whose pituitary system is disrupted, for example by surgery, tumour, radiation or head injury, and people with active cancer. The other two are a known allergy to tesamorelin or its other ingredients, and pregnancy. The label also says mothers on it should not breastfeed, and that it is not for use in children. It adds a caution for people with a past cancer that was treated and is stable. It says to start only after weighing "the risk of re-activation of the underlying malignancy." FDA Egrifta SV Label 2024

A 12-week trial in 53 people with type 2 diabetes tested 1 mg and 2 mg against placebo. There was no significant difference against placebo in blood sugar control or insulin response. Always work with a qualified clinician before making changes to your health protocol. Clemmons et al. 2017

Is there a tested tesamorelin ipamorelin dosage?

No. We found no trial of tesamorelin with ipamorelin or with CJC-1295 among the sources on this page. The labels list no such use. DailyMed Egrifta SV 2024

They are different kinds of drug. Tesamorelin and CJC-1295 are GHRH analogs. The 2026 list of the World Anti-Doping Agency (WADA) puts CJC-1295 and tesamorelin under GHRH analogues, and ipamorelin under growth hormone secretagogues. A secretagogue is anything that makes a gland release a hormone. WADA 2026 Prohibited List

So any blend dose, such as a set tesamorelin and ipamorelin mix, is not drawn from a trial. Our ipamorelin dosing and stacking with tesamorelin guide has what is known about ipamorelin. And tesamorelin versus ipamorelin puts them side by side. See our CJC-1295 comparison and stacking strategy guide for CJC-1295.

Which labs does the label name for a tesamorelin dosage protocol?

The label names three checks. It says to monitor IGF-1 during treatment. It says to check glucose before starting and at intervals after. DailyMed Egrifta SV 2024

For people with diabetes, it adds eye checks for retinopathy, damage to the back of the eye. The label says to consider stopping in patients with persistently raised IGF-1 (for example above 3 SDS).

The label gives no fixed schedule, such as a test every 12 weeks. It also gives no rule for stopping after two high readings in a row.

  • IGF-1 staying high: the label says consider stopping, especially if the fat response is weak.
  • New glucose intolerance or diabetes: the label says consider stopping in patients without a clear fat response.
  • No fall in visceral fat: the label says weigh the risks and benefits of going on. In the Phase 3 data, a responder lost at least 8%. Fourman et al. 2017

Always work with a qualified clinician before making changes to your health protocol.

Where does lawful tesamorelin come from, and what is the dosage for tesamorelin outside the label?

Tesamorelin is licensed as a biologic (BLA 022505), so pharmacies cannot lawfully compound it; only FDA-licensed Egrifta products are lawful sources. A biologic is a medicine FDA licenses as a biological product. Its licence is a BLA, or biologics licence application. Drugs@FDA lists Egrifta 1 mg and 2 mg vials under BLA 022505, first approved on 10 November 2010. FDA's Egrifta WR label is filed under the same application number. Compounding means a pharmacy mixing its own version of a drug. Drugs@FDA, BLA 022505 FDA Egrifta WR Label 2025.

FDA said in 2020 that biological products moving to licences on 23 March 2020 would not be eligible for compounding under sections 503A and 503B. Those are the parts of US drug law that let pharmacies compound. FDA Notice to Compounders, 2020

Outside the label, few trials exist, and none sets an approved dose. One 12-month trial tested tesamorelin in 60 adults with belly obesity and reduced growth hormone output. Its participants were not selected for HIV. It gave 2 mg a day or placebo. Makimura et al. 2012.

On a CT scan, visceral fat fell by 16 square centimetres on tesamorelin and rose by 19 on placebo. Blood sugar measures did not change. No trial on this page tested bodybuilding use or blends. Makimura et al. 2012.

We keep a vetted, vendor-neutral sources list. See our recommended sources page for how we assess suppliers.

Where to buy tesamorelin

In the US, the lawful source of tesamorelin is FDA-licensed Egrifta, by prescription. Our sources page explains how we assess research suppliers.

See the sources that passed →

References

This content is for educational purposes only. These compounds are intended for research use. Nothing here is medical advice. Always work with a qualified clinician before making changes to your health protocol.

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Frequently Asked Questions

What is the standard FDA-approved dose of tesamorelin?
The approved dose depends on the brand. Original Egrifta is 2 mg a day. Egrifta SV is 1.4 mg a day. Egrifta WR is 1.28 mg a day. All three are once-daily shots under the skin. The labels give no lower starting week and no step-up.
How much visceral fat does tesamorelin reduce and how quickly?
In the two main trials, visceral fat fell 18% and 14% on average after 26 weeks of 2 mg a day. On placebo it changed by +2% and -2%. The loss held for patients who stayed on it to 52 weeks. In those switched to placebo, it came back.
When is the best time to inject tesamorelin for fat loss?
No time has been shown to work better. The label says once a day and gives no time of day or rule about meals. No trial on this page compared bedtime with morning dosing. The label does say Egrifta SV must be used as soon as it is mixed.
Do you need to cycle tesamorelin or take breaks from it?
No trial on this page tested cycles or breaks. The main trials ran 52 weeks with no break. When patients were switched to placebo, visceral fat came back. The label says to consider stopping if IGF-1 stays high, or if visceral fat has not fallen.
What are the main side effects of tesamorelin to monitor?
Reactions at the needle site hit 25% of patients on it against 14% on placebo. Puffy hands and feet came in at 6.1%. Joint pain and carpal tunnel signs showed up too. By week 26, HbA1c, a three-month blood sugar measure, was 6.5% or more in 5% on it against 1% on placebo. The label says to monitor IGF-1 and blood sugar.
Can you stack tesamorelin with ipamorelin or CJC-1295?
No study on this page tested either stack, and the label lists no such use. Tesamorelin and CJC-1295 are both GHRH analogs. Ipamorelin is a different kind of growth hormone secretagogue. Any blend dose is not drawn from a trial.

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Disclaimer: This content is for educational purposes only. These compounds are intended for research use. Nothing here is medical advice. Always work with a qualified clinician before making changes to your health protocol.