Tesamorelin (EGRIFTA SV)
An FDA-approved growth hormone-releasing factor analog for reducing excess abdominal fat in adults with HIV-associated lipodystrophy—not for general weight loss.
OVERVIEW
Tesamorelin is a growth hormone-releasing factor analog. EGRIFTA SV is FDA-approved for reducing excess abdominal fat in adults with HIV-associated lipodystrophy. It is not indicated for weight-loss management.
Proposed Mechanisms
• Stimulates pituitary growth hormone production • Raises downstream IGF-1
Potential Applications
FDA-approved use: reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. General weight loss, anti-aging, and body-composition optimization are not approved indications.
Pharmacokinetics
Product-specific. Refer to the current EGRIFTA SV prescribing information.
Dosing
Current EGRIFTA SV label: 1.4 mg subcutaneously once daily. The source draft's 2 mg daily may reflect a different or older formulation and should not be published as a universal dose.
Monitoring
• IGF-1 • Glucose before and during therapy • Clinical response and adverse effects
Side Effects
Common label-reported reactions include arthralgia, injection-site erythema or pruritus, pain in an extremity, peripheral edema, and myalgia.
Contraindications
• Disruption of the hypothalamic-pituitary axis • Active malignancy • Known hypersensitivity to tesamorelin or product excipients • Pregnancy
FDA/Investigational Status
FDA-approved only for the labeled EGRIFTA SV indication. The label states that long-term cardiovascular safety has not been established and that the drug is not indicated for weight-loss management.
Disclaimer/Notes
Use product-specific labeling. Do not generalize approval to longevity, wellness, or routine weight-management uses.
Clinical Review Status
Clinical + legal review required before publishing