Tesamorelin 10mg/mL

Administered by subcutaneous injection once daily. The recommended injection site is the abdomen, avoiding the navel, scar tissue, bruises, or lumps from prior injections. Rotate injection sites within the abdominal region with each dose. Inspect the reconstituted solution visually; do not use if particulate matter or discoloration is observed.

The established clinical dose for tesamorelin is 2 mg subcutaneously once daily. The 10 mg/mL concentration is a compounded strength prepared to allow smaller injection volumes for patient convenience. Final dose, frequency, and duration are determined by the prescribing clinician based on individual clinical response, IGF-1 levels, and tolerability.

• Monitor IGF-1 levels at baseline and periodically during therapy.
• Evaluate glucose status before initiating and monitor throughout.
• If efficacy response is not adequate, the prescriber should reassess continuation.

• Tesamorelin: Acts as a GHRH receptor agonist on anterior pituitary somatotroph cells, stimulating the pulsatile synthesis and release of endogenous growth hormone. The resulting GH elevation increases hepatic and peripheral production of IGF-1, which mediates lipolysis of visceral adipocytes, reduces triglyceride synthesis, and improves lipid redistribution. Unlike exogenous GH administration, tesamorelin preserves physiologic pulsatility.

Tesamorelin is indicated clinically for reduction of excess visceral (abdominal) adiposity in HIV-infected patients with antiretroviral therapy-associated lipodystrophy. Off-label compounding use may target metabolic syndrome, age-related visceral adiposity, or non-alcoholic fatty liver disease under prescriber direction. It is not indicated for general weight loss management.

Monitoring considerations:

• Baseline and periodic IGF-1 levels; consider discontinuation if persistently elevated (>3 SD above mean).
• Fasting glucose and HbA1c before and during therapy (risk of glucose intolerance and new-onset diabetes).
• Clinical assessment of efficacy (visceral fat reduction) at approximately 26 weeks.
• Assess for fluid retention signs: edema, arthralgia, carpal tunnel syndrome.

Contraindications:

• Disruption of the hypothalamic-pituitary axis (hypophysectomy, pituitary tumor/surgery, head irradiation, head trauma)
• Active malignancy
• Known hypersensitivity to tesamorelin or any excipient
• Pregnancy

Warnings & Precautions:

• Increased risk of neoplasm recurrence: discontinue if evidence of malignancy returns
• Elevated IGF-1: monitor levels; supraphysiologic elevation may stimulate tumor growth
• Fluid retention: edema, arthralgia, carpal tunnel syndrome may develop
• Glucose intolerance/new-onset diabetes mellitus: evaluate and monitor blood glucose
• Hypersensitivity reactions (rash, urticaria, flushing): discontinue if suspected
• Increased mortality in acute critical illness: consider discontinuation in critically ill patients

Drug Interactions:

• Corticosteroids may attenuate tesamorelin's GH-stimulating effects
• Tesamorelin may alter the metabolism of drugs that are CYP450 substrates (GH is known to modulate CYP enzyme activity)
• Anti-diabetic medications may require dose adjustment due to glucose intolerance risk

Common Side Effects: Arthralgia, injection site erythema and pruritus, pain in extremities, peripheral edema, myalgia, hyperglycemia, and hypersensitivity reactions.

Store unreconstituted vials as directed by the compounding pharmacy (typically refrigerated at 2–8°C / 36–46°F; protect from light; do not freeze). Once reconstituted per pharmacy instructions, use within the beyond-use date (BUD) established by Genesis Compounding. Discard any unused portion after the BUD. Do not use if the solution appears discolored or contains visible particulates.

What is tesamorelin used for?

Tesamorelin stimulates the pituitary gland to release growth hormone, which helps reduce visceral (abdominal) fat. It is used clinically in HIV-associated lipodystrophy and, under prescriber direction, in other conditions involving excess visceral adiposity.

How do I administer this injection?

Inject subcutaneously into the abdomen once daily, rotating sites with each injection. Avoid the navel and any areas with scars or lumps. Follow your prescriber's reconstitution and injection instructions carefully.

Is this medication FDA-approved?

Tesamorelin (Egrifta) is FDA-approved as a branded product for HIV-related lipodystrophy. This compounded preparation is not FDA-approved as a compounded drug; it is prepared by Genesis Compounding under a valid prescriber order for a specific patient per 503A regulations.

What lab tests are needed while taking tesamorelin?

Your prescriber will monitor IGF-1 levels periodically to ensure they remain within an acceptable range and will check fasting blood glucose and HbA1c to detect glucose intolerance, which can occur with tesamorelin use.

How should I store this medication?

Keep unreconstituted vials refrigerated and protected from light. Do not freeze. After reconstitution, follow the beyond-use dating provided by the pharmacy. Discard unused portions after the labeled BUD.