How to enroll your patient in the THERA patient support® Program

How to enroll your patient in the THERA patient support® Program

Once you have identified an appropriate EGRIFTA WRTM patient, you can enroll them in the THERA patient support® program in 2 ways:

1

Enroll via fax

  • Download the enrollment form
  • Print the enrollment form and fill it out, including the signed patient consent section on the back page
  • Scan it and fax it to 1-855-836-3069
OR
2

Enroll online

  • Visit the Physician Portal
  • Register to create an account
  • Complete the online enrollment form, which includes the signed patient consent section
  • Upload chart notes and track patients’ real-time enrollment status
  • Obtain coverage information and view product shipment information

Need assistance enrolling your patients? Call THERA patient support® at 1-833-23THERA (1-833-238-4372). Available Monday to Friday from 8:30 AM – 8:00 PM EST.

To ensure your patients can immediately get started on EGRIFTA WRTM therapy, it is important to fill out the form in full and obtain patient consent.

Patient consent

Patients can provide consent by signing the last page of the enrollment form.

If your patient is unable to sign the back of the enrollment form, they can also provide their consent digitally by:

  • Visiting here OR
  • Calling THERA patient support® at 1‑833‑23THERA (1‑833‑238-4372) and requesting a consent link via SMS

If patient consent is not on file, a THERA patient support® Patient Care Coordinator will reach out to your patient and request consent via SMS.

Remind your patients to save 1-833-23THERA (1-833-238-4372)—the THERA patient support® number—in their contacts to ensure they never miss important updates and always know who is calling.

Visit the THERA patient support® Physician Portal to seamlessly enroll patients online, upload the signed patient consent form and chart notes, track patients’ real-time enrollment status, obtain coverage information, and view the EGRIFTA WRTM shipment information.

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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.