EGRIFTA SV® (tesamorelin for injection): Building on 10+ years of established safety†
Within the Phase 3 studies, 740 PWHIV who had lipodystrophy and excess abdominal fat received EGRIFTA®; of these, 543 received EGRIFTA® during the initial 26‑week placebo‑controlled Main Phase studies.1
The most commonly reported adverse events were:1
Hypersensitivity reactions (rash, urticaria)
Edema-related reactions (e.g., arthralgia, pain in extremity, peripheral edema, and carpal tunnel syndrome)
Hyperglycemia
Injection site reactions (e.g., injection site erythema, pruritis, pain, urticaria, irritation, swelling, and hemorrhage)
Most common adverse events reported during the Main Phase and Extension Phase studies1,2†
Main Phase Studies
Events reported in >5% of patients
Combined Main Phase Studies (Baseline – Week 26)
Adverse Event (%)
EGRIFTA® (n=543)
Placebo (n=263)
Injection site reaction†
17
6
Arthralgia†
16
11
Pain in extremity†
6
5
Myalgia
6
2
Peripheral edema
6
2
Extension Phase Studies
Events reported in >5% of patients
Combined Main Phase Studies (Week 26 – Week 52)
Adverse Event (%)
E/E (n=92)
E/P (n=85)
P/E (n=86)
Diarrhea
3.3
4.7
5.8
Injection site erythema
3.3
0.0
5.8
Injection site pain
0.0
0.0
5.8
URTI
8.7
4.7
3.5
Musculoskeletal stiffness
1.1
0.0
5.8
Paraesthesia
2.2
3.5
5.8
Insomnia
0.0
0.0
5.8
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.
E = EGRIFTA®; P = placebo; PWHIV = people with HIV. † 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®.
References:
EGRIFTA SV® (tesamorelin for injection) Prescribing Information. Theratechnologies Inc. October 2019.
Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone‑releasing factor, in HIV‑infected patients with abdominal fat accumulation: a randomized placebo‑controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311-322.
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
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.
Renal and Hepatic Impairment: Use in renal and hepatic impairment has not been studied.
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.
