Adverse Reactions
The most commonly reported adverse reactions include injection site reactions, arthralgia, pain in extremity, myalgia, and peripheral edema.
 
For a complete disclosure of EGRIFTA SV® product information, please read the Full Prescribing Information, Patient Information, and Patient Instructions for Use available at www.egriftasv.com.
 
For more information about EGRIFTA SV®, contact                                       toll-free at 1-833-23THERA (1-833-238-4372). To report suspected adverse reactions, contact                                       toll-free or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION ABOUT EGRIFTA SV® (TESAMORELIN) FOR INJECTION

Indication
EGRIFTA SV® is indicated for the reduction of excess abdominal fat in people with HIV and lipodystrophy.

  • 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.
 Limitations of Use
Contraindications
Do not use EGRIFTA SV® if patient:
Drug Interactions
  • 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.
  • 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.

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