EGRIFTA SV®

EGRIFTA SV®

Tim is a real EGRIFTA SV® patient.
Tim was compensated for his time.

Before EGRIFTA SV®, my stomach was hard, and I felt constricted. I was worried about my health and what it would mean for my future. Today, I feel like myself again.

- Tim, currently taking EGRIFTA SV®
Watch Tim’s story
There is more to treating people with HIV than viral suppression
REDUCE THE IMPACT of central adiposity
EGRIFTA SV® is the ONLY FDA‑approved treatment for reducing excess abdominal fat in HIV‑infected patients with lipodystrophy.

27% demonstrated reduction in excess visceral abdominal fat in responders after 26 weeks of treatment.2†‡

EGRIFTA SV® has a weight‑neutral effect, and may increase lean body mass by up to 5 pounds and has no BMI requirement.2

Explore the 26‑week and 52‑week data

The results of the post‑hoc responder analysis were not part of the NDA, and therefore were not reviewed by the FDA to support the approval of EGRIFTA®.

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

EGRIFTA SV® is not indicated for weight loss management.

EGRIFTA SV® is not approved for use in clinical conditions other than the reduction of excess abdominal fat.

EGRIFTA SV® is a GHRH analog that helps exert anabolic and lipolytic effects.1

See how it works

EGRIFTA SV® is not approved for use in clinical conditions other than the reduction of excess abdominal fat.

† In two multicenter, randomized, double‑blind, placebo‑controlled studies. The primary outcome for these trials was change from Week 26 to Week 52 in central adiposity (i.e., excess visceral abdominal fat) by treatment group (EGRIFTA® Week 0–52 or EGRIFTA® Week 0–26 and placebo Week 26–52). In a post‑hoc responder analysis of data, ≥8% decrease in excess visceral abdominal fat was determined to be clinically significant and used to define responders.
‡ A single‑slice CT scan was used to quantify excess visceral abdominal fat.
§ 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®.
ART = antiretroviral therapy; BMI = body mass index; FDA = Food and Drug
Administration; NDA = New Drug Application; PWHIV = people with HIV.

References:

  1. EGRIFTA SV® (tesamorelin for injection) Prescribing Information. Theratechnologies Inc. October 2019.
  2. Stanley TL, Falutz J, Marsolais C, et al. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV‑infected patients receiving tesamorelin. Clin Infect Dis. 2012;54(11):1642-1651.

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 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.

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.

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 www.fda.gov/medwatch.

Please see full Prescribing Information for EGRIFTA SV®.