Safety Data

EGRIFTA SV® (tesamorelin for injection): Building on 10+ years of established safety

Within the Phase 3 studies, 740 PWHIV who had lipodystrophy and excess abdominal fat 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

  • Hypersensitivity reactions (rash, urticaria)
  • Edema-related reactions (e.g., arthralgia, pain in extremity, peripheral edema, and carpal tunnel syndrome)
  • Hyperglycemia
  • Injection site reactions (e.g., injection site erythema, pruritis, pain, urticaria, irritation, swelling, and hemorrhage)

Most common adverse events reported during the Main Phase and Extension Phase studies1,2†

Main Phase Studies
Events reported in >5% of patients
Combined Main Phase Studies
(Baseline – Week 26)
Adverse Event (%)EGRIFTA®
Injection site reaction176
Pain in extremity65
Peripheral edema62

Extension Phase Studies
Events reported in >5% of patients
Combined Main Phase Studies
(Week 26 – Week 52)
Adverse Event (%)E/E
Injection site erythema3.30.05.8
Injection site pain0.00.05.8
Musculoskeletal stiffness1.10.05.8

The safety and effectiveness of EGRIFTA SV® has been established based on adequate and well‑controlled studies with EGRIFTA® (tesamorelin for injection).

EGRIFTA® was approved in 2010 and EGRIFTA SV® in 2019.

E = EGRIFTA®; P = placebo; PWHIV = people with HIV.
† The safety of EGRIFTA SV® (2 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA® (1 mg/vial formulation). Adverse events 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®.


  1. EGRIFTA SV® (tesamorelin for injection) Prescribing Information. Theratechnologies Inc. October 2019.
  2. Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone‑releasing factor, in HIV‑infected patients with abdominal fat accumulation: a randomized placebo‑controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311-322.

IMPORTANT SAFETY INFORMATION (Please see below for full limitations of use and additional important safety information)


EGRIFTA SV® 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 SV® on cardiovascular health have not been studied.
  • EGRIFTA SV® is not indicated for weight loss management.
  • It is not known whether taking EGRIFTA SV® helps improve compliance with anti‑retroviral medications.


Do not use EGRIFTA SV® 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 SV®.
  • Is pregnant or planning to become pregnant.

Warnings and Precautions

Drug Interactions

Use in Specific Populations

Adverse Reactions

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

To report suspected adverse reactions, contact THERA patient support® at 1‑833‑23THERA (1‑833‑238-4372) or FDA at 1‑800‑FDA-1088 or

Please see full Prescribing Information for EGRIFTA SV®.