Reconstitution

Brief overview of EGRIFTA SV^® reconstitution¹

Preparing EGRIFTA SV^® for injection

The daily 1.4 mg dose of EGRIFTA SV^® is reconstituted from a vial containing 2 mg of tesamorelin as a lyophilized powder in a single‑dose vial.

The total volume of reconstitution is 0.35 mL.
Sterile Water for Injection, USP (10 mL) for reconstitution is provided in a separate bottle.

Once reconstituted, EGRIFTA SV^® should be administered immediately.

Fill syringe with sterile water to 0.5 mL line

Inject sterile water into EGRIFTA SV^® vial and roll vial gently in your hands for 30 seconds

Full instructions can be found in the Instructions for Use

Download a Step‑by‑Step Administration Guide for your patients

Watch how a patient prepares
EGRIFTA SV^® for administration

Reference:

EGRIFTA SV^® (tesamorelin) for injection Prescribing Information. Theratechnologies Inc. February 2024.

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.

Please see full Prescribing Information for EGRIFTA SV^®.

Brief overview of EGRIFTA SV® reconstitution1

Preparing EGRIFTA SV® for injection