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Starting patients on GATTEX

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Steps to starting patients on GATTEX

This brochure walks you through the steps you need to take to prescribe GATTEX and explains how OnePath® works with eligible patients to assist in accessing treatment as prescribed.

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GATTEX Start Form

To prescribe GATTEX, complete the Start Form available below. Filling out this form also registers your eligible patients with OnePath.

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OnePath Support

Shire OnePath® Patient Support Manager Welcome Brochure

Your patients enrolled in OnePath will be assigned a dedicated Patient Support Manager. This brochure helps you understand their role and the services they offer your patients.

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Instructions for Use

Patients should read the Instructions for Use before they start using GATTEX and each time they get a refill. A healthcare provider or nurse will show the patient how to prepare, measure the dose, and give the injection of GATTEX the right way.

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Dosage Table

This helpful tool provides calculations for a range of weights (90-200 lb). Download and print a copy to keep on hand.


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Weaning PN/IV support

This resource provides an overview for healthcare professionals of the weaning protocol from the GATTEX clinical trials, STEPS and STEPS-2.

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Clinical insights

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Learn about the importance of GLP-2

This brochure explores the critical role of GLP-2 in the intestines and explains how GATTEX works

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Specialty Pharmacy

GATTEX is provided to patients who are prescribed GATTEX through a limited distribution specialty pharmacy network. For more information about GATTEX distribution, please call 1-844-MY1-PATH.

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OnePath provides a range of product support services throughout your patients' GATTEX treatment journey. From the moment your patients enroll in OnePath, a dedicated Patient Support Manager will work with them one on one to help them access the support and treatment they need. Your patients will also be introduced to an Onboarding & Access Specialist in their area, who will be one of their primary support persons as they get started on therapy.

The OnePath team is here to help your patients:

  • Navigate the health insurance process
  • Learn about financial assistance options
  • Connect with reimbursement education
  • Coordinate with specialty pharmacy
  • Set up injection training with a nurse
  • Stay informed about additional resources

Patient Support Manager

After patients enroll in OnePath, they will be assigned a dedicated Patient Support Manager who will be their main point of contact throughout their treatment journey. The Patient Support Manager will work with your patients one on one to help them access GATTEX. He or she will help your patients navigate many different aspects of their therapy, from insurance and financial options to training and prescription fulfillment.

Onboarding & Access Specialist (OAS)

Once patients have enrolled in OnePath, a local OAS will arrange a time to meet in person to discuss the first steps to getting started on therapy. The OAS will work to help them gain consistent access to GATTEX.

Indication:
GATTEX® (teduglutide) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Important Safety Information:

Warnings and Precautions:
GATTEX has been associated with possible acceleration of neoplastic growth, intestinal obstruction, biliary and pancreatic disease, fluid imbalance and fluid overload, and increased absorption of concomitant oral medication. Click here for additional Important Safety Information.

Click here for additional Important Safety Information.

Indication

GATTEX® (teduglutide) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Important Safety Information

Warnings and Precautions

Acceleration of neoplastic growth

Colorectal polyps were identified during clinical trials. There is a risk for acceleration of neoplastic growth. Within 6 months prior to starting treatment with GATTEX, colonoscopy (or alternate imaging) of the entire colon with removal of polyps should be performed and follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. Subsequent colonoscopies should be performed every 5 years or more often as needed. In case of intestinal malignancy (GI tract, hepatobiliary, pancreatic), discontinue GATTEX. The clinical decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on benefit-risk considerations.

Intestinal obstruction

Intestinal obstruction has been reported in clinical trials and postmarketing. In patients who develop intestinal or stomal obstruction, GATTEX should be temporarily discontinued pending further clinical evaluation and management.

Biliary and pancreatic disease

Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported in clinical trials and postmarketing. Laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) should be obtained within 6 months prior to starting GATTEX. Subsequent laboratory tests should be done every 6 months or more often as needed. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and continued treatment with GATTEX should be reassessed.

Fluid imbalance and fluid overload

Fluid overload and congestive heart failure have been observed in clinical trials. If fluid overload occurs, especially in patients with underlying cardiovascular disease, parenteral support should be adjusted and GATTEX treatment reassessed. If significant cardiac deterioration develops while on GATTEX, continued GATTEX treatment should be reassessed.

Discontinuation of treatment with GATTEX may also result in fluid and electrolyte imbalance. Fluid and electrolyte status should be monitored in patients who discontinue treatment with GATTEX.

Increased absorption of concomitant oral medication

In clinical trials, one patient receiving prazepam concomitantly with GATTEX experienced dramatic deterioration in mental status progressing to coma during first week of GATTEX therapy. Patients receiving concomitant oral drugs requiring titration or with a narrow therapeutic index should be monitored for adverse reactions due to potential increased absorption of the concomitant drug. The concomitant drug may require a reduction in dosage.

Adverse Reactions

The most common adverse reactions (≥10%) with GATTEX are abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.

Use in Specific Populations

Breastfeeding is not recommended during treatment with GATTEX.

Please click here for full Prescribing Information.