Tesamorelin Dosage Guide

Tesamorelin (brand name Egrifta®) is a synthetic analog of growth hormone-releasing hormone (GHRH) consisting of the 44-amino acid sequence of human GHRH with a trans-3-hexenoic acid modification at the N-terminus. This modification provides enhanced stability against enzymatic degradation.

Tesamorelin is the only FDA-approved GHRH analog currently on the market. Clinical trials (Phase III) demonstrated significant reductions in visceral adipose tissue (VAT) of approximately 15–18% over 26 weeks. It stimulates physiologic GH release while maintaining normal pulsatile patterns.

Tesamorelin uses a straightforward, fixed-dose protocol:

The FDA-approved dose is 2 mg administered once daily by subcutaneous injection. Unlike many peptides, tesamorelin does not require dose titration. Clinical efficacy has been demonstrated primarily at the 2 mg dose.

Tesamorelin is administered once daily. Per the Egrifta® prescribing information, it can be injected at any time of day. However, many clinicians recommend evening dosing to leverage the natural nocturnal GH surge.

Food interaction: There are no specific food restrictions, though fasting for 1–2 hours before injection may optimize GH release.

Duration: Clinical trials ran for 26–52 weeks. The prescribing information recommends assessing treatment response at 26 weeks — if trunk fat has not decreased, consider discontinuation. Visceral fat may reaccumulate upon cessation.

Egrifta® comes with a multi-dose vial and diluent:

• Step 1: Allow vial to reach room temperature.
• Step 2: Inject 2.1 mL of the provided sterile water into the 2 mg vial.
• Step 3: Roll the vial gently between your palms for 30 seconds. Do not shake.
• Step 4: Let sit for 1–2 minutes. Reconstituted solution should be clear and colorless.
• Step 5: Withdraw the entire contents (2 mg) and inject subcutaneously into the abdomen.

Rotate injection sites within the abdominal area. Avoid injecting into scar tissue, bruises, or the navel area. Use immediately after reconstitution — do not store reconstituted solution.

• 2 mg/day (standard): Most common side effects in clinical trials were injection site reactions (erythema, pruritus) in up to 8.5% of subjects, arthralgia (6.4%), peripheral edema (5.8%), and myalgia (3.4%).
• Fluid retention effects: Carpal tunnel syndrome occurred in 1.3% of subjects. Paresthesias (tingling) were reported at similar rates.

In the Phase III TESAMORELIN trial, discontinuation due to adverse events was 7.1% for tesamorelin vs 5.2% for placebo. IGF-1 levels increased by a mean of 81% but remained within the age-normal range in most subjects.

Tesamorelin is FDA-approved for HIV-associated lipodystrophy only. Off-label use should only occur under medical supervision.

Contraindicated in pregnancy (Category X), disruption of the hypothalamic-pituitary axis (hypophysectomy, pituitary surgery/radiation), and known hypersensitivity. Monitor IGF-1 levels and discontinue if persistent elevations above the age-adjusted normal range occur. Screen for pre-existing malignancies before initiation.