Building on 10+ Years of Established Safety with EGRIFTA®1*

Within the Phase 3 studies, 740 PWH who had lipodystrophy and central adiposity received EGRIFTA®; of these, 543 received EGRIFTA® during the initial 26-week placebo-controlled Main Phase studies.1

The most commonly reported adverse events were:1

The most common reported adverse events:1,2*

Main Phase Studies
Events reported in >5% of patients
Combined Main Phase Studies (Baseline – Week 26)
Adverse Event (%) EGRIFTA ® (n=543) Placebo (n=263)
Injection site reaction 17 6
Arthralgia 16 11
Pain in extremity 6 5
Myalgia 6 2
Peripheral edema 6 2
Extension Phase Studies
Events reported in >5% of patients
Combined Extension Phase (Week 26 – Week 52)
Adverse Event (%) E/E (n=92) E/P (n=85) P/E (n=86)
Diarrhea 3.3 4.7 5.8
Injection site erythema 3.3 0.0 5.8
Injection site pain 0.0 0.0 5.8
URTI 8.7 4.7 3.5
Musculoskeletal stiffness 1.1 0.0 5.8
Paraesthesia 2.2 3.5 5.8
Insomnia 0.0 0.0 5.8

The safety and effectiveness of EGRIFTA WRTM has been established based on adequate and well-controlled studies with EGRIFTA®.

EGRIFTA® was approved in 2010, EGRIFTA SV® in 2019, and EGRIFTA WRTM in 2025.

* The safety of EGRIFTA WRTM (11.6 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA® (1 mg/vial formulation). Adverse events for the 1.28 mg dose (11.6 mg/vial formulation) of EGRIFTA WRTM are expected to be similar to those observed with the 2 mg dose (1 mg/vial formulation) of EGRIFTA®.

E = EGRIFTA®; P = Placebo; PWH = people with HIV.

References:

  1. Theratechnologies Inc. EGRIFTA WRTM (tesamorelin) for injection Prescribing Information. March, 2025.
  2. Falutz J, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010;95(9):4291-4304.

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IMPORTANT SAFETY INFORMATION ABOUT EGRIFTA WRTM (TESAMORELIN) FOR INJECTION

Indication

EGRIFTA WRTM is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Limitations of Use:

  • The impact and safety of EGRIFTA WRTM on cardiovascular health has not been studied.
  • EGRIFTA WRTM is not indicated for weight loss management.
  • It is not known whether taking EGRIFTA WRTM helps improve compliance with anti-retroviral medications.

Contraindications:

Do not use EGRIFTA WRTM if patient:

  • Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or a head injury.
  • Has active cancer.
  • Is allergic to tesamorelin or any of the ingredients in EGRIFTA WRTM.
  • Is pregnant or planning to become pregnant.

Warnings and Precautions

  • Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA WRTM. EGRIFTA WRTM should be discontinued if the patient has evidence of recurrent malignancy.
  • Elevated IGF-1: Regularly monitor IGF-1 levels in all patients during EGRIFTA WRTM therapy. Consider discontinuing in patients with persistent elevations (e.g., >3 SDS).
  • Fluid retention: May include edema, arthralgia, and carpal tunnel syndrome.
  • Glucose intolerance or diabetes mellitus: May develop with EGRIFTA WRTM treatment. Evaluate glucose status prior to and during therapy with EGRIFTA WRTM.
  • Hypersensitivity reactions: Advise patients to seek immediate medical attention if suspected.
  • Injection site reactions: Advise patients to rotate sites to different areas of the abdomen to decrease injection site reactions.
  • Increased mortality in patients with acute critical illness: Consider discontinuation in critically ill patients.

Drug Interactions

  • EGRIFTA WRTM had no significant impact on the pharmacokinetic profiles of simvastatin in healthy subjects.
  • Monitor patients for potential interactions when administering EGRIFTA WRTM in combination with other drugs known to be metabolized by CYP450 liver enzyme.
  • Patients on glucocorticoids may require dosage adjustment upon initiation of EGRIFTA WRTM.

Use in Specific Populations

  • Lactation: Mothers should not breastfeed if they receive EGRIFTA WRTM.
  • Pediatric use: Safety and effectiveness in pediatric patients have not been established.
  • Geriatric use: There is no information on the use of EGRIFTA WRTM in patients greater than 65 years of age.

Adverse Reactions

The most commonly reported adverse reactions include injection site reactions, arthralgia, pain in extremity, myalgia, and peripheral edema.

For complete disclosure of EGRIFTA WRTM product information, please read the Full Prescribing Information, Patient Information, and Patient Instructions for Use.

For more information about EGRIFTA WRTM, contact THERA patient support® program toll-free at 1-833-23THERA (1-833-238-4372). To report suspected adverse reactions, contact THERA patient support® program or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.