Discover EGRIFTA WRTM From a Patient Perspective

Meet William*

“No matter what I do, I can’t lose this excess visceral abdominal fat.”

* Stock photo. Not a real patient. Data is reflective of clinical trial results.

Overview

  • William is 45 and has had HIV and has been on ART for 9 years
  • He noticed the changing shape and increasing size of his belly
  • He tried diets, exercise, and stress management but did not see results
  • It is difficult for him to bend and turn over in bed
  • William is worried and would like to do something about his medical condition

William’s progress (WC)

After 12 weeks of treatment:

  • William has lost a total of 2.2 inches around his waist
  • His stomach feels softer
  • He feels positive about his progress

Clinical studies with EGRIFTA® demonstrate:

Average reduction in EVAF1,2†‡

26 weeks

16% in patients treated with EGRIFTA®

27% in responders§

52 weeks

18% in patients treated with EGRIFTA®

31% in responders§

Average reduction in WC in responders2§

26 weeks

1.65”

52 weeks

1.85”

Reduction in triglyceride levels in responders2§

26 weeks

20.8% (50 mg/dL from 240 mg/dL)

52 weeks

27.5% (68 mg/dL from 247 mg/dL)

The results of the post-hoc 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 WRTM has been established based on adequate and well-controlled studies with EGRIFTA® (tesamorelin for injection).

EGRIFTA WRTM is not indicated for weight loss management.

EGRIFTA WRTM is not indicated to reduce triglyceride levels.

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

† The primary outcome for these trials was change from Week 0–26 in VAT by treatment group.
‡ A single-slice CT scan was used to quantify VAT.
§ An ≥8% decrease in VAT area was determined to be clinically significant and used to define responders a priori.

Medical History

  • Hypertension, well-controlled with medication
  • Hyperlipidemia, treated with atorvastatin, fenofibrates, and fish oil
  • Low testosterone, treated with topical testosterone replacement
  • No history of opportunistic infections
  • No history of hepatitis co-infection
  • Non-smoker

Initial Assessment

Weight 189 lbs
Height 5’10”
WC 40.2” (102 cm)
Hip circumference 37” (94 cm)
Waist-to-hip ratio 1.09
BMI 27.1 kg/m2

Looking for resources to support you and your patients?

Discover helpful guides and tools designed to help you and your patients in their EGRIFTA WRTM journey.

ART = antiretroviral therapy; CT = computed tomography; EVAF = excess visceral abdominal fat; FDA = Food and Drug Administration; HC = hip circumference; NDA = New Drug Application; PWH; people with HIV; VAT, visceral adipose tissue; WC = waist circumference; WHR = waist-to-hip ratio.

References:

  1. Theratechnologies Inc. EGRIFTA WRTM (tesamorelin) for injection Prescribing Information. March, 2025.
  2. Stanley TL, 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.

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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.