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Current regulator label
Tesamorelin is a growth-hormone-releasing factor analog FDA-approved as EGRIFTA SV for HIV-associated lipodystrophy; this reference page covers what it is, its regulatory status, route, and safety context — for reconstitution and unit math, use the Tesamorelin Dosage Calculator.
Tesamorelin dosage calculator →
Arithmetic only, not medical advice.
Tesamorelin: reference record
| Regulatory status | FDA-approved as EGRIFTA SV for a specific HIV-associated lipodystrophy indication |
|---|---|
| Route | Subcutaneous |
| Dosing frequency | Once daily |
| Published range | 1.4 mg |
| Evidence basis | Current regulator label |
| Common vial sizes | 5, 10, 20 |
Sources
- FDA prescribing information (Tesamorelin) - accessdata.fda.govBasis for the regulatory status, route, frequency and published range in the table above. Source last checked 2026-06-24
What is Tesamorelin?
Tesamorelin is a growth-hormone-releasing factor analog and the active ingredient in EGRIFTA SV. Unlike most entries in this library, it is a genuinely lyophilized product that the label directs you to reconstitute before use.
Is Tesamorelin FDA-approved?
Yes, for one specific indication. Tesamorelin is FDA-approved as EGRIFTA SV for HIV-associated lipodystrophy. The approval is narrow, and it does not extend to general body-composition or anti-aging use.
How is Tesamorelin given?
Subcutaneously, once daily, per the current label. It is the one compound here where the approved product is a powder requiring reconstitution, and the label specifies both the mixing volume and the volume to withdraw.
What are the known safety concerns with Tesamorelin?
Use is limited to the labeled indication and the exact labeled formulation. IGF-1 and glucose monitoring accompany its labeled use and sit with a prescriber, outside the scope of any calculator.
EGRIFTA SV: 1.4 mg once daily. Label mixes a 2 mg vial with 0.5 mL and withdraws 0.35 mL
For the labeled product: 2 mg / 0.5 mL = 4 mg/mL; 1.4 mg / 4 = 0.35 mL.
Use only for the labeled indication and exact formulation; IGF-1/glucose monitoring is outside this calculator.
Supply-chain quality · Finnrick
Avg quality score
6.1
/10
Purity range
85.61
–
99.95
%
Qty divergence
±
100
%
Vendors · samples
51
·
440
Common vial sizes
5, 10, 20
mg
Test window
May 2025 - May 2026
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