Reconstitution

Brief overview of EGRIFTA SV® reconstitution1

Preparing EGRIFTA SV® for injection

The daily 1.4 mg dose of EGRIFTA SV® is reconstituted from a vial containing 2 mg of tesamorelin as a lyophilized powder in a single‑dose vial.

  • The total volume of reconstitution is 0.35 mL.
  • Sterile Water for Injection, USP (10 mL) for reconstitution is provided in a separate bottle.

Once reconstituted, EGRIFTA SV® should be administered immediately.

Fill syringe with sterile water to 0.5 mL line

Inject sterile water into EGRIFTA SV® vial and roll vial gently in your hands for 30 seconds

Full instructions can be found in the Instructions for Use

Reference:

  1. EGRIFTA SV® (tesamorelin) for injection Prescribing Information. Theratechnologies Inc. February 2024.

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

Indication

EGRIFTA SV® is indicated for the reduction of excess abdominal fat in people with HIV and 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.

Contraindications:

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.

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

Please see full Prescribing Information for EGRIFTA SV®.