Could your patients with HIV be struggling with excess visceral abdominal fat? Could it be time for 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.
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.
Could your patients with HIV and lipodystrophy be struggling with excess visceral abdominal fat?
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.
No matter what I do, I can’t lose this excess visceral abdominal fat.Take a closer look
Meet Patty¶
I’ve grown self‑conscious about my excess visceral abdominal fat, and I don’t socialize like I used to.Take a closer look
Meet Brian¶
I’ve recently changed my ART and have noticed an increase in my visceral abdominal fat.Take a closer look
¶ Stock photo. Posed by model. Data is reflective of clinical trial results.
† 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:
EGRIFTA SV® (tesamorelin) for injection Prescribing Information. Theratechnologies Inc. February 2024.
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 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
Increased risk of neoplasms: Preexisting malignancy should be inactive, and its treatment complete prior to starting EGRIFTA SV®. EGRIFTA SV® should be discontinued if the patient has evidence of recurrent malignancy.
Elevated IGF‑1: Monitor regularly IGF‑1 levels in all patients during EGRIFTA SV® 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 SV® use. Evaluate glucose status prior to and during therapy with EGRIFTA SV®.
Hypersensitivity reactions: Advise patients to seek immediate medical attention and discontinue treatment if suspected.
Injection site reactions: Advise patients to rotate injection 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 SV® had no significant impact on the pharmacokinetic profiles of simvastatin in healthy subjects.
Monitor patients for potential interactions when administering EGRIFTA SV® in combination with other drugs known to be metabolized by CYP450 liver enzyme.
Patients on glucocorticoids may require dosage adjustment upon initiation of EGRIFTA SV®.
Use in Specific Populations
Lactation: Mothers should not breastfeed if they receive EGRIFTA SV®.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: There is no information on the use of EGRIFTA SV® 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 more information about EGRIFTA SV®, contact toll‑free at 1‑833‑23THERA (1‑833‑238-4372).To report suspected adverse reactions, contact at 1‑833‑23THERA (1‑833‑238-4372) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.
toll‑free at 1‑833‑23THERA (1‑833‑238-4372).To report suspected adverse reactions, contact