Tesamorelin 15mg/mL
Tesamorelin 15mg/mL is used in prescriber-directed longevity, peptide, antioxidant, or skin-longevity protocols. Published evidence varies substantially by ingredient, so the page avoids unsupported disease-treatment claims.
Tesamorelin 15 mg/mL is a high-concentration subcutaneous injectable preparation of tesamorelin, a synthetic GHRH analogue that stimulates physiologic pituitary growth hormone release. The 15 mg/mL strength provides an even smaller injection volume for patients requiring standard 2 mg daily dosing, minimizing injection volume-related discomfort. Genesis Compounding prepares this as a prescription-only, patient-specific 503A compounded preparation and it is not FDA-approved as a compounded product.
| Active Ingredient | Pharmacologic Role |
|---|---|
| Tesamorelin 15 mg/mL | Synthetic GHRH analogue that stimulates pituitary GH secretion, raises IGF-1, and promotes visceral adipose tissue lipolysis. |
Administered by subcutaneous injection once daily. Inject into the abdomen, rotating sites with each administration. Avoid the navel, scar tissue, bruises, or areas with nodules from prior injections. The 15 mg/mL concentration is formulated to allow a very small injection volume. Inspect the solution before use; discard if discolored or particulates are visible.
The established clinical dose for tesamorelin is 2 mg subcutaneously once daily. At 15 mg/mL, this dose corresponds to approximately 0.13 mL per injection. Final dosing and duration are prescribed by the clinician based on IGF-1 response, glucose tolerance, and clinical efficacy.
- Baseline IGF-1 and fasting glucose should be obtained prior to initiation.
- Clinical reassessment of visceral fat response is recommended at approximately 26 weeks.
- Discontinue if IGF-1 becomes persistently supraphysiologic or if malignancy recurs.
- Tesamorelin: Binds to pituitary GHRH receptors to stimulate pulsatile growth hormone (GH) release. Elevated GH increases hepatic IGF-1 production, promoting lipolysis of visceral adipocytes, reducing lipogenesis, and improving lipid redistribution—without the supra-physiologic GH spikes associated with exogenous recombinant GH.
The 15 mg/mL concentration is a compounded variant offering ultra-small injection volumes for daily tesamorelin dosing. Clinical context mirrors the 10 mg/mL preparation: visceral adiposity reduction in HIV-associated lipodystrophy or other prescriber-directed indications.
Monitoring:
- Periodic IGF-1 measurement; dose or drug should be reassessed if IGF-1 consistently exceeds 3 SD above the age-adjusted mean.
- Fasting glucose and HbA1c before initiation and at regular intervals thereafter.
- Monitor for fluid retention (edema, carpal tunnel symptoms).
- Assess for signs of malignancy recurrence in patients with oncologic history.
Contraindications:
- Hypothalamic-pituitary axis disruption
- Active malignancy
- Hypersensitivity to tesamorelin or excipients
- Pregnancy
Warnings & Precautions:
- Neoplasm risk: do not initiate in active malignancy; discontinue if recurrence detected
- IGF-1 elevation: supraphysiologic levels carry unknown long-term risk; monitor and consider discontinuation if persistent
- Glucose intolerance and new-onset type 2 diabetes mellitus
- Fluid retention: edema, arthralgia, carpal tunnel syndrome
- Hypersensitivity reactions (rash, urticaria, erythema)
Drug Interactions:
- Glucocorticoids may blunt GH response
- GH-related CYP enzyme modulation may alter metabolism of CYP substrates
- Anti-diabetic agents may require adjustment
Common Side Effects: Injection site reactions (erythema, pruritus, pain), arthralgia, myalgia, peripheral edema, hyperglycemia.
Store unreconstituted vials refrigerated at 2–8°C; protect from light; do not freeze. After reconstitution, use within the beyond-use date assigned by Genesis Compounding. Discard unused product after the BUD. Do not use if the solution is cloudy or contains particulates.
Why is this a 15 mg/mL concentration instead of the standard Egrifta formulation?
The 15 mg/mL concentration is a compounded strength designed to deliver the standard 2 mg daily dose in a smaller injection volume, which may improve patient comfort and injection site tolerability compared to lower-concentration preparations.
How is this injected?
Inject subcutaneously into the abdomen once daily, rotating the injection site each time. Avoid the navel and any areas with prior injection lumps or scar tissue.
Is this FDA-approved?
This is a 503A compounded preparation prepared by Genesis Compounding under a valid prescriber's order. It is not FDA-approved as a compounded product. The branded tesamorelin product (Egrifta) carries FDA approval.
What monitoring is required?
Regular monitoring of IGF-1 levels and blood glucose (fasting glucose or HbA1c) is essential. Your prescriber will determine the appropriate monitoring schedule.
What side effects should I watch for?
Common side effects include injection site redness, itching, or pain; joint and muscle aches; ankle or leg swelling; and elevated blood sugar. Report any signs of allergic reaction or fluid retention to your prescriber.
Clinical References
Authoritative sources reviewed in preparing this clinical summary. Provided for prescriber reference; not a substitute for the prescriber’s clinical judgment.