Protocols · Muscle & Performance · Tesamorelin
Research Protocol · Educational

Tesamorelin
Dosage Protocol

Tesamorelin is FDA-approved as EGRIFTA SV, and that approved dose is shown here for context. For the 10 mg vial, you'll find the reconstitution math and an investigational titration schedule reported for off-label use, kept clearly apart, with every figure sourced to the protocol guide and peer-reviewed literature cited.

Tesamorelin
Tesamorelin · 10 mg · research use only
FDA-approved dose
1.4 mg/day
Reconstitute
3.0 mL BAC water
Concentration
3.33 mg/mL
Storage
2–8 °C · ≤7 days
Dosage

Dosage Chart

Regulatory note. Tesamorelin is FDA-approved under the brand name EGRIFTA SV for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy, at the labeled dose below. The investigational titration schedule, which runs above the approved label, applies only to off-label use and should involve a qualified healthcare provider. [4]
ContextDaily doseUnits (U-100)Volume
FDA-approved (EGRIFTA SV)1.4 mg42 u0.42 mL
Investigational, Week 11 mg (1,000 mcg)30 u0.30 mL
Investigational, Weeks 2+2 mg (2,000 mcg)60 u0.60 mL

The labeled EGRIFTA SV dose is administered once daily subcutaneously for the approved indication. [4] The investigational schedule uses 1 mg for tolerability in week 1, then 2 mg once daily from week 2 onward, which is higher than the approved label. [5] A 60-unit dose exceeds the marked capacity of a standard 0.3 mL/30-unit syringe; a 1 mL/100-unit syringe is needed at that dose.

Prep

Reconstitution

10 mg vial, mixed to a working concentration before drawing a dose.

Add 3.0 mL of bacteriostatic water to the 10 mg vial, yielding a concentration of approximately 3.33 mg/mL. [5] Inject the water slowly down the vial wall, then gently swirl until dissolved without shaking; vigorous shaking may denature the peptide. [5]

Before reconstitution, refrigerate the lyophilized form at 2–8 °C. Once reconstituted, do not freeze and avoid repeated freeze-thaw cycles; store at 2–8 °C. [5] Use the reconstituted solution within 7 days. [5]

Mechanism

How It Works

Tesamorelin is a synthetic peptide analog of growth hormone-releasing hormone (GHRH, also called growth hormone-releasing factor). It functions as a GHRH receptor agonist at the pituitary gland, stimulating endogenous growth hormone release rather than providing direct hormone replacement. [4][3]

A systematic review and meta-analysis reported that tesamorelin 2 mg significantly reduced visceral adipose tissue and increased lean body mass in HIV patients on antiretroviral therapy, though discontinuation rates were higher in treatment groups than in controls. [1] A separate pilot study of low-dose tesamorelin (1 mg) found no direct significant changes in cognitive or physical measures, though machine learning analysis suggested potential treatment-related differences in brain regions associated with cognitive function. [2] Reductions in visceral fat have been reported not to persist after discontinuation, suggesting the effects are treatment-dependent. [4]

Tesamorelin is FDA-approved under the brand name EGRIFTA SV for a specific indication: reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Approval is limited to this population and does not extend to general weight loss, anti-aging, or athletic performance uses; those uses are off-label. [4] Compounded versions lack the FDA premarket review and quality assurance of the approved EGRIFTA SV product. [4] This section describes what the cited literature reports; it is not a claim of safety or effectiveness for off-label use.

Evidence

References

Educational use only. This content is for research and educational purposes only and is not medical advice, diagnosis, or treatment. Tesamorelin is FDA-approved only under the brand name EGRIFTA SV, for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. All other uses, including the investigational titration schedule on this page, are off-label and not FDA-approved for those purposes. Compounded versions lack the FDA premarket review and quality assurance of the approved brand product. It is not intended for human consumption outside a prescribed, approved use. Clinical decisions should involve a qualified healthcare provider.