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tesamorelin · egrifta sv · egrifta wr · fda label

Tesamorelin dosage calculator

Tesamorelin is FDA-approved as Egrifta. The Egrifta SV label dose is 1.4 mg, which is 0.35 mL (35 units on a U-100 scale) from a 2 mg vial mixed with 0.5 mL. Egrifta WR is 1.28 mg, or 0.16 mL, at the label's 8 mg/mL.

Open Peptide Calculator editorial teamUpdated 18 sources

tesamorelin_calculator

preset: Egrifta SV label (2 mg vial + 0.5 mL, 1.4 mg)

mg
mL
Syringe size (U-100)

Calculating…

Formula. Concentration = mg in vial ÷ mL added. Units = (dose ÷ concentration) × 100 on a U-100 syringe. This tool does math only and does not recommend doses.

FDA-approved, prescription onlyTesamorelin is approved as Egrifta (first approved November 10, 2010) to reduce excess abdominal fat in adults with HIV and lipodystrophy.[1][3] The label says it is "not indicated for weight loss management". The numbers below are the label's, shown so the arithmetic can be checked. Use the volumes your prescriber and pharmacist give you.

What is the tesamorelin peptide?

Tesamorelin is a 44-amino-acid synthetic copy of human growth-hormone-releasing hormone, GHRH(1-44), with a trans-3-hexenoyl group added to its first amino acid; it weighs about 5,136 g/mol.[3][18] It acts on the pituitary to release growth hormone, and it is the only peptide of its kind with a current FDA approval. How it compares with sermorelin is on sermorelin vs tesamorelin.

Tesamorelin dosage chart from the Egrifta labels

Two tesamorelin products are sold today, and they are mixed and dosed differently.

Egrifta SV and Egrifta WR prescribing information (effective July 29, 2026)
Egrifta SV[3]Egrifta WR[4]
Vial2 mg, single-dose11.6 mg, single-patient-use
DiluentSterile Water for InjectionBacteriostatic Water for Injection, USP
Liquid added0.5 mL1.3 mL
Concentration (label)2 mg per 0.5 mL8 mg per mL
Daily dose1.4 mg = 0.35 mL1.28 mg = 0.16 mL
U-100 equivalent of that volume35 units16 units
After mixingUse immediately; discard leftover7 daily doses per vial; discard 7 days after mixing
Storage before mixing20–25 °C, protected from light20–25 °C in the original carton

The labels state doses in millilitres. The U-100 column is only the arithmetic equivalent (mL × 100). The Egrifta WR label adds: "EGRIFTA WR and EGRIFTA SV are not substitutable."[4] The newer product was approved on March 25, 2025 as "a new formulation, new multiple-dose product presentation".[2]

Why Egrifta WR breaks the simple formula

For Egrifta SV the calculator matches the label exactly: 2 mg ÷ 0.5 mL = 4 mg/mL, and 1.4 mg ÷ 4 = 0.35 mL.[3] Try the same with Egrifta WR and it does not:

# naive: vial mg ÷ liquid mL11.6 ÷ 1.3 = 8.92 mg/mL → 1.28 mg = 0.143 mL (14.3 units)# label: 8 mg/mL1.28 ÷ 8 = 0.16 mL (16 units)

The label's concentration is 8 mg/mL, not 8.92.[4] Seven daily doses of 1.28 mg use 8.96 mg, less than the 11.6 mg on the vial. The label does not explain the difference in these terms, but the arithmetic shows the vial contains more than seven doses' worth and the final solution is not simply 11.6 ÷ 1.3. The lesson applies to every product: when a label states a concentration, use it, not your own division. To check Egrifta WR in the calculator, enter 8 mg and 1 mL, which is the label's concentration, and an amount of 1.28 mg: the result is 0.16 mL. Ignore the calculator's "doses per vial" in that case (it will say 6.3, because you entered 8 mg); the label says each Egrifta WR vial provides 7 daily doses.[4]

What the trials showed

In two phase 3 trials, tesamorelin reduced visceral abdominal fat compared with placebo without changing body weight.

Tesamorelin evidence in adults with HIV and abdominal fat
StudyDesignDoseMain result
Falutz 2007, NEJM[9]Phase 3 RCT, 412 adults, 26 weeks2 mg under the skin dailyVisceral fat −15.2% vs +5.0% on placebo; triglycerides −50 vs +9 mg/dL
Label, studies 1 and 2[3]Two phase 3 RCTs (412 and 404 adults)2 mg daily (original formulation)Visceral fat −18% vs +2% and −14% vs −2%; body weight not different from placebo
Falutz 2010, pooled[10]806 adults, both phase 3 trials2 mg dailyVisceral fat −15.4% treatment effect at 26 weeks
Stanley 2014, JAMA[11]RCT, 50 adults, 6 months2 mg dailyLiver fat reduced (net −2.9% lipid-to-water ratio)

The trials used the original Egrifta at 2 mg a day.[5] The current Egrifta SV label dose is 1.4 mg, a different formulation.[3] The most common side effects on the label (over 5%) are joint pain, injection-site redness and itching, pain in the arms or legs, swelling, and muscle pain. The label says long-term cardiovascular safety "has not been established".[3]

Tesamorelin side effects on the label

The most common side effects on the Egrifta SV label are injection-site reactions, joint pain, pain in the arms or legs, swelling and muscle pain; the label also warns about raised IGF-1 and glucose intolerance.[3]

Adverse reactions more common than placebo, 26-week trials (Egrifta SV label, Table 1, %)
ReactionTesamorelin (n = 543)Placebo (n = 263)
Injection-site reaction176
Joint pain (arthralgia)1311
Pain in arms or legs65
Muscle pain (myalgia)62
Swelling of arms or legs (peripheral edema)62
Tingling (paresthesia)52
Reduced sensation (hypoesthesia)42
Rash42
Vomiting30
  • IGF-1. "Among patients who received EGRIFTA for 26 weeks, 47% had IGF-1 levels greater than 2 standard deviation scores (SDS), and 36% had SDS >3." The label says to monitor IGF-1 and consider stopping if it stays high.[3]
  • Glucose. HbA1c rose to 6.5% or more in 5% on tesamorelin vs 1% on placebo; the label asks for glucose to be checked before starting.[3]
  • Fluid retention. Swelling, joint pain and carpal tunnel syndrome are linked to fluid retention and are "either transient or resolve with discontinuation".[3]
  • Injection sites. Section 5.6 gives injection-site reactions as 25% vs 14%, while Table 1 shows 17% vs 6%; the table counts a narrower set of terms. Both are on the same label.[3]

The safety data come from trials of the original 1 mg-vial Egrifta, which the label says establish the safety of Egrifta SV.[3]

Why tesamorelin cannot be compounded

Tesamorelin has 44 amino acids.[18] Since a 2020 rule, any amino acid chain longer than 40 counts as a protein,[8] so Egrifta was transferred to a biologics license on March 23, 2020.[6] The FDA says such biological products "are not eligible for the exemptions for compounded drugs".[7]

That has not stopped online sellers. In August 2026 the FDA sent warning letters to five sellers of "research" peptides that offered tesamorelin, some of them as a tesamorelin and ipamorelin blend.[12][13][14][15][16] Those products are unapproved drugs, not Egrifta. Tesamorelin is also on the WADA 2026 list under S2.2.4, approved or not.[17] For how it compares with sermorelin and ipamorelin, see HGH peptides compared.

Other peptide pages

The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.

Frequently asked questions

How many units is 1.4 mg of tesamorelin?

With the Egrifta SV label mix (2 mg vial + 0.5 mL), 1.4 mg is 0.35 mL, which equals 35 units on a U-100 syringe. The label gives the dose in mL.[3]

How much water do you mix with Egrifta SV and Egrifta WR?

Egrifta SV: 0.5 mL of Sterile Water for Injection per 2 mg vial. Egrifta WR: 1.3 mL of Bacteriostatic Water for Injection per 11.6 mg vial. Each label names its own diluent.[3][4]

Why does 11.6 mg in 1.3 mL not give 8.9 mg/mL?

The Egrifta WR label states the mixed concentration as 8 mg/mL. Use the label figure. Simple division of vial strength by liquid volume does not always equal a product's stated concentration.

What are the side effects of tesamorelin?

On the label, injection-site reactions (17% vs 6% on placebo in Table 1), joint pain, muscle pain, swelling and tingling are the most common; raised IGF-1 and glucose intolerance are listed warnings.[3]

Is tesamorelin approved for weight loss?

No. The label says Egrifta is "not indicated for weight loss management". Its approved use is reducing excess abdominal fat in adults with HIV and lipodystrophy.[3]

Sources

  1. Drugs@FDA: Egrifta (tesamorelin), BLA 022505 · U.S. Food and Drug Administration, accessed November 13, 2026
  2. Approval letter, BLA 022505/S-020 (Egrifta WR) · U.S. Food and Drug Administration, March 25, 2025
  3. Egrifta SV (tesamorelin) prescribing information · FDA label via openFDA, effective July 29, 2026
  4. Egrifta WR (tesamorelin) prescribing information · DailyMed, U.S. National Library of Medicine, effective July 29, 2026
  5. Egrifta (tesamorelin) prescribing information, original 2010 label · U.S. Food and Drug Administration, November 2010
  6. List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 · U.S. Food and Drug Administration, 2020
  7. Notice to compounders: changes that affect compounding as of March 23, 2020 · U.S. Food and Drug Administration, March 5, 2020
  8. Final rule: Definition of the term "biological product" (85 FR 10057) · U.S. Food and Drug Administration, Federal Register, February 21, 2020
  9. Falutz J et al. Tesamorelin phase 3 trial in HIV-infected patients with abdominal fat accumulation (NEJM 2007;357:2359–70) · New England Journal of Medicine, December 6, 2007
  10. Falutz J et al. Pooled analysis of two phase 3 tesamorelin trials (JCEM 2010;95:4291–304) · Journal of Clinical Endocrinology & Metabolism, 2010
  11. Stanley TL et al. Tesamorelin and liver fat in HIV (JAMA 2014;312:380–9) · JAMA, July 23, 2014
  12. Warning letter: Royal Peptides LLC · U.S. Food and Drug Administration, August 24, 2026
  13. Warning letter: NuScience Peptides LLC · U.S. Food and Drug Administration, August 24, 2026
  14. Warning letter: Peak Performance Peptides · U.S. Food and Drug Administration, August 24, 2026
  15. Warning letter: TXP Innovations LLC dba Tex Peptides · U.S. Food and Drug Administration, August 24, 2026
  16. Warning letter: Peptide Partners LLC · U.S. Food and Drug Administration, August 24, 2026
  17. World Anti-Doping Code: Prohibited List 2026 · World Anti-Doping Agency, in effect January 1, 2026
  18. PubChem CID 16137828: tesamorelin · PubChem, NCBI, accessed November 13, 2026