Tesamorelin

In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF [see Clinical Pharmacology ( 12.2 )]. Growth hormone-releasing factor (GHRF), also known as growth hormone-releasing hormone (GHRH), is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH), which is both anabolic and lipolytic.

• EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established.ICD-10: B20

• EGRIFTA SV is contraindicated in: Patients with disruption of the hypothalamic-pituitary axis ( 4 ) Patients with active malignancy ( 4 ) Patients with known hypersensitivity to tesamorelin or excipients in EGRIFTA SV ( 4 ) Pregnancy ( 4 ) EGRIFTA SV is contraindicated in: Patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. Patients with active malignancy.contraindicated

The recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. ( 2.1 ). The dose of EGRIFTA SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily. ( 2.1 ) Inject EGRIFTA SV into the abdomen, rotating injection sites. ( 2.1 , 5.6 ) Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. ( 2.2 ) Reconstitute one vial of lyophilized powder with 0.5 mL of diluent. Mix by rolling the vial gently in your hands for 30 seconds. Do not shake. ( 2.2 ) Inspect the reconstituted vial visually for particulate matter and discoloration. Use only if the solution is clear, colorless and without particulate matter. ( 2.2 ) Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. ( 2.2 ) 2.1 Dosage and Administration • The dosage and administration recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For dosage and administration recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information.

Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA SV . Discontinue EGRIFTA SV if there is any evidence of recurrent malignancy. ( 5.1 ) Elevated IGF-1: EGRIFTA SV stimulates GH production and increases serum IGF-1, a growth factor. The effects of prolonged elevations in IGF-1 levels are unknown. Monitor IGF-1 levels during EGRIFTA SV therapy. Consider discontinuing in patients with persistent elevations. ( 5.2 ) Fluid retention: May occur with EGRIFTA SV and may include edema, arthralgia, and carpal tunnel syndrome. ( 5.3 ) Glucose intolerance or diabetes mellitus: May develop with EGRIFTA SV use. Evaluate glucose prior to and during therapy. ( 5.4 ) Hypersensitivity reactions: Have occurred in clinical trials. Advise patients to seek immediate medical attention and discontinue treatment if suspected. ( 5.5 ) Increased mortality in patients with acute critical illness: Consider discontinuation in critically ill patients . ( 5.7 ) 5.1 Increased Risk of Neoplasms New Malignancy Carefully consider the decision to start treatment with EGRIFTA SV based on the increased background risk of malignancies in HIV-positive patients. Active Malignancy EGRIFTA SV induces the release of endogenous growth hormone (GH), a known growth factor. Do not treat patients with active malignancy with EGRIFTA SV [see Contraindications ( 4 )] . History of Malignancy For patients with a history of non-malignant neoplasms, initiate EGRIFTA SV therapy after careful evaluation of the potential benefit of treatment.

The following important adverse reactions are also described elsewhere in the labeling: Increased risk of neoplasms [see Warnings and Precautions ( 5.1 )] Elevated IGF-1 levels [see Warnings and Precautions ( 5.2 )] Fluid retention [see Warnings and Precautions ( 5.3 )] Glucose intolerance or diabetes mellitus [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] Injection site reactions [see Warnings and Precautions ( 5.6 )] Most commonly reported adverse reactions (>5%): Arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact THERA patient support ® toll free at 1-833-23THERA (1-833-238-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EGRIFTA SV (2 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA (1 mg/vial formulation). Adverse reactions for the 1.4 mg dose (2 mg/vial formulation) of EGRIFTA SV are expected to be similar to those observed with the 2 mg dose (1 mg/vial formulation) of EGRIFTA [see Clinical Pharmacology ( 12.3 )].

Lactation: HIV-1 infected mothers should not breastfeed to avoid potential postnatal transmission of HIV-1. ( 8.2 ) 8.1 Pregnancy Risk Summary EGRIFTA SV is contraindicated in pregnant women because modifying visceral adipose tissue offers no benefit in pregnant women and could result in fetal harm [see Clinical Considerations and Contraindications ( 4 )] . Administration of tesamorelin acetate to rats during organogenesis resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, based on measured drug exposure (AUC). If EGRIFTA SV is used during pregnancy, or if the patient becomes pregnant while taking it, discontinue EGRIFTA SV. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes. Modifying pregnancy-associated physiologic changes in visceral adipose tissue with EGRIFTA SV offers no known benefit and could result in fetal harm.

Metabolism

Absorption The absolute bioavailability of tesamorelin after subcutaneous administration of a 2 mg dose of EGRIFTA (1 mg/vial formulation) was determined to be less than 4% in healthy adult subjects. Single and multiple dose pharmacokinetics have been characterized in healthy subjects and HIV-infected patients without lipodystrophy using a 2 mg dose of EGRIFTA (1 mg/vial formulation).

• Nov 10, 2010BLABLA022505Theratechnologies

1. 1Product Dose Omission Issue27818%
2. 2Incorrect Dose Administered16411%
3. 3Injection Site Pain1308.6%
4. 4Product Preparation Issue1218.0%
5. 5Drug Ineffective1197.9%
6. 6Weight Increased966.4%
7. 7Arthralgia885.8%
8. 8Therapeutic Product Effect Incomplete865.7%
9. 9Injection Site Bruising855.6%
10. 10Wrong Technique In Product Usage Process785.2%
11. 11Injection Site Pruritus724.8%
12. 12Pain In Extremity704.6%
13. 13Fatigue573.8%
14. 14Peripheral Swelling533.5%
15. 15Product Dose Omission In Error513.4%

The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Tesamorelin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Body Composition and Adipose Tissue in HIV
  Terminated · Phase 4 · Interventional · 6 enrolled · Columbia University
  NCT03226821updated 2026-05-19
• Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
  Recruiting · Phase 2 · Interventional · 100 enrolled · Massachusetts General Hospital
  NCT06554717updated 2026-05-19
• Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
  Recruiting · Phase 2 · Interventional · 120 enrolled · Hudson Biotech
  NCT07481734updated 2026-03-19
• Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
  Completed · Phase 2 · Interventional · 73 enrolled · University of California, San Diego
  NCT02572323updated 2026-03-12
• Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
  Completed · Phase 2 · Interventional · 51 enrolled · Massachusetts General Hospital
  NCT03375788updated 2025-11-20
• Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
  Recruiting · Phase 2 · Interventional · 36 enrolled · Johns Hopkins University
  NCT03150511updated 2025-11-12
• TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
  Completed · Phase 3 · Interventional · 263 enrolled · Theratechnologies
  NCT00608023updated 2022-09-30
• Growth Hormone Dynamics and Cardiac Steatosis in HIV
  Completed · Observational · 23 enrolled · Massachusetts General Hospital
  NCT03826160updated 2022-07-19
• Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
  Terminated · Phase 2 · Interventional · 3 enrolled · Theratechnologies
  NCT01388920updated 2022-03-18
• Tesamorelin Effects on Liver Fat and Histology in HIV
  Completed · Interventional · 61 enrolled · Massachusetts General Hospital
  NCT02196831updated 2020-01-27

Frequently asked questions

How does Tesamorelin work?

In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF [see Clinical Pharmacology ( 12.2 )]. Growth hormone-releasing factor (GHRF), also known as growth hormone-releasing hormone (GHRH), is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH), which is both anabolic and lipolytic.

What is Tesamorelin used for?

According to FDA labeling, Tesamorelin carries indications including: EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tesamorelin?

Tesamorelin is classified as Somatropin and somatropin agonists, Growth Hormone Releasing Factor Analog, Insulin-like Growth Factor-1 Receptor Interactions, Increased GHRH Activity, Increased Growth Hormone Secretion, Pituitary Gland Activity Alteration.

What are the brand names for Tesamorelin?

Tesamorelin is marketed under brand names including Egrifta.

What are the contraindications for Tesamorelin?

Tesamorelin labeling lists contraindications including: EGRIFTA SV is contraindicated in: Patients with disruption of the hypothalamic-pituitary axis ( 4 ) Patients with active malignancy ( 4 ) Patients with known hypersensitivity to tesamorelin or excipients in EGRIFTA SV ( 4 ) Pregnancy ( 4 ) EGRIFTA SV is contraindicated in: Patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. Patients with active malignancy.. Always consult the full prescribing information and a clinician.