No matter what I do, I can’t lose this excess visceral abdominal fat.
† Stock photo. Posed by model. 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 (waist circumference)
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 tesamorelin for injection demonstrate:
Average reduction in excess visceral abdominal fat in responders
26 weeks
16% in patients treated with tesamorelin for injection‡ 27% in responders§
52 weeks
18% in patients treated with tesamorelin for injection‡ 31% in responders§
Average reduction in waist circumference in responders§
26 weeks1.65”
52 weeks1.85”
Reduction in triglyceride levels in responders§
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 responder analysis were not part of the New Drug Application (NDA), and therefore were not reviewed by the FDA to support approval of EGRIFTA®. Tesamorelin is not indicated to reduce triglyceride levels.
‡ In two multicenter, randomized, placebo‑controlled trials. The primary outcome for these trials was change from Week 26 to Week 52 in excess visceral abdominal fat by treatment group (tesamorelin for injection Week 0–52 or tesamorelin for injection 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.
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”
Waist circumference
40.2” (102 cm)
Hip circumference
37” (94 cm)
Waist-to-hip ratio
1.09
Could your patients with HIV and lipodystrophy be struggling with excess visceral abdominal fat?
Not all patients respond to tesamorelin for injection.
Patients responses may vary.
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.
ART = antiretroviral therapy.
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.