Resources for You and Your Patients

Resources for healthcare professionals

Prescribing Information

View the complete product information for EGRIFTA WRTM.

EGRIFTA WRTM Summary Brochure

Learn about the EGRIFTA WRTM mechanism of action, key data, dosing and administration, and more.

Resources for patients

Patient Information Brochure

Provide patients with information about EGRIFTA WRTM and why it could be an option for them.

Doctor Discussion Guide

Help patients have informed conversations with their doctor about EVAF and EGRIFTA WRTM therapy.

My EGRIFTA WRTM Handbook

Equip your EGRIFTA WRTM patients with valuable knowledge on EGRIFTA WRTM, including the importance of adherence, what to expect from treatment, and understanding common side effects.

Step-by-step Administration Guide

Provide your patients with step-by-step instructions on how to mix and inject EGRIFTA WRTM.

Step-by-Step Administration Video

A detailed video walkthrough for preparing and administering EGRIFTA WRTM will be available shortly. Please check back soon for updates.

Resources for THERA patient support® program

THERA patient support® Brochure for Healthcare Professionals

A comprehensive summary of the services offered by the THERA patient support® program to you and your patients on EGRIFTA WRTM therapy.

THERA patient support® Patient Brochure

A comprehensive patient guide on the services offered by the THERA patient support® program to support them on their EGRIFTA WRTM treatment journey.

EGRIFTA WRTM Enrollment Form

Get your patients started with the THERA patient support® program by downloading the EGRIFTA WRTM Enrollment Form.

Access tools for the THERA patient support® program

To learn more about the services offered by THERA patient support®, how to enroll your patients in the program, and how to help your patients access their EGRIFTA WRTM treatment.

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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.