Starting Patients on GATTEX

  • Step 1
  • Step 2
  • Step 3
  • Step 4

Step 1

Complete the GATTEX Risk Evaluation and Mitigation Strategy (REMS) program

The purpose of GATTEX (teduglutide) REMS is to inform healthcare providers, patients, and caregivers about the following risks:

Acceleration of neoplastic growth and enhancement of colon polyp growth

Gastrointestinal obstruction

Biliary and pancreatic disorders

Please review REMS education materials and complete the knowledge assessment at gattexrems.com. REMS materials are also available through your GATTEX representative.

Step 2

Counsel your patient

Please share the appropriate REMS materials with your patients and their caregivers, including:

The Medication Guide prior to starting therapy, ensuring they fully understand the risks and benefits of GATTEX

The Patient & Caregiver Counseling Guide to review during each visit

Both resources are available at gattexrems.com

Please ensure the patient or their caregiver has filled out their section of the Start Form, reviewed the patient authorizations, and signed the Start Form.

After they have signed the Start Form, give your patient or their caregiver the Guidance for Patients resource to provide more information about available Takeda Patient Support for patients on GATTEX.

Please be sure to fill out the Patient Support Manager (PSM) and Onboarding & Access Specialist (OAS) contact information provided by your Regional Business Manager (RBM) prior to giving it to the patient or their caregiver.

Step 3

Submit the Takeda Patient Support Start Form with signed patient consent

The Start Form serves as the prescription for GATTEX and enrolls your patients in Takeda Patient Support.

Takeda Patient Support provides product support services to eligible patients prescribed GATTEX, including arranging specialty pharmacy ordering and providing a dedicated Takeda Patient Support Specialist. Refer to the Guidance for Patients resource for more information

Please fill out the insurance and prescribing physician information, diagnosis, etiology, and prescription sections completely. Incomplete forms may cause delays in treatment.

Confirm that the patient or their caregiver has completed the patient information section of the Start Form and that they’ve read the Takeda Patient Support authorization and consent form

Both patient and prescriber signatures are required to authorize this form. If your patient or their caregiver is unable to make it into the office to sign the form, Takeda Patient Support can obtain their consent via alternate methods. If you have any questions about the consent process, please contact your Takeda representative

GATTEX Start Forms are available through your Takeda representative and
can be completed the following ways:

Fill out and submit the form electronically

Download and complete a physical copy and fax to 1-855-359-3393

Icons and background images are purely decorative elements and do not convey additional meaning, content, or information to users who rely on screen readers. As such, they do not require alt text for accessibility purposes.

How would you like to complete the GATTEX Start Form?

Complete online or print and fax

Please be aware that the GATTEX Start Form is not an insurance prior authorization. For questions, please call 1-866-888-0660.

Step 4

Perform safety assessments within 6 months prior to starting GATTEX treatment1

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In adult patients:

  • Perform a colonoscopy of the entire colon and upper GI endoscopy with removal of polyps1

  • Obtain baseline laboratory assessment (bilirubin, alkaline phosphatase, lipase, and amylase)1

For additional adult monitoring timelines, click here.

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In children ≥1 year of age:

  • Perform fecal occult blood testing; if there is unexplained blood in the stool, perform colonoscopy/sigmoidoscopy and an upper GI endoscopy1

  • Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase, and amylase)1

For additional pediatric monitoring timelines, click here.

Fill out the Start Form to enroll your patient in Takeda Patient Support.