Resources

Explore GATTEX services to help with your patients' treatment journey

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A helpful resource designed to provide patients and their caregivers with product support

With OnePath, each eligible patient is partnered with a dedicated Patient Support Manager and an Onboarding and Access Specialist (OAS) who can assist with many aspects of treatment, including:

Navigating health insurance icon

Navigating health insurance

in-home product delivery icon

Working with the specialty pharmacy to coordinate in-home product delivery

information about financial assistance options

Providing information about financial assistance options

treatment journey support icon

Providing ongoing education throughout the treatment journey

free nurse injection training icon

Coordinating free injection training, if requested by the healthcare professional

Download this guide to learn more about the full OnePath journey.

Visit OnePath.com or call 1-866-888-0660 to get started. Patient Support Managers are available Monday-Friday, 8:30 AM-8:00 PM ET.

Meet the OnePath support team

The OnePath support team is committed to providing personalized, one-on-one services to help patients access their prescribed treatment.

  • Patient Support Manager (PSM) A dedicated contact who provides your patient with continuous product support throughout the treatment journey, such as:
    • Helping your patient understand and navigate insurance coverage
    • Coordinating delivery with specialty pharmacies (SPs)
    • Assisting your patient when preparing to travel with medication
  • Onboarding and Access Specialist (OAS) A local OnePath member who will be the primary support contact during the onboarding process and during the first few months of treatment. The OAS will meet with your patients in their home or another convenient location to answer questions and guide them through treatment initiation, including:
    • Reviewing available insurance and financial assistance options
    • Providing educational information about treatment, including a product resource kit
  • Specially trained Nurse Educators (ie, GATTEX Injection Training Nurse) OnePath will arrange for a specially trained Nurse Educator to provide free, in-home, self-administration training for patients and caregivers

Download this guide for more information about Onboarding & Access Specialists.

Visit OnePath.com

Onboarding and Access specialists brochure

Office Support

Support materials for you and your office

 

Start Form

Download the Start Form.

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Getting Started With GATTEX

Learn about the steps you need to take to get appropriate patients started on GATTEX.

Learn More

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 and measure the dose and to give the injection of GATTEX the right way.

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Weaning Adults Off of PN/IV Support

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

Download

Spanish Prescribing Information

Información de prescripción en español

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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 1-866-888-0660.

Diagnosis Codes

Commonly used ICD-10 codes for short bowel syndrome (SBS)1

K00-K95Diseases of the digestive system
K91Intraoperative and postprocedural complications and disorders of the digestive system, not elsewhere classified
K91.2Postsurgical malabsorption, not elsewhere classified, postsurgical blind loop syndrome

Indication
GATTEX® (teduglutide) for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older 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. In adults, within 6 months prior to starting treatment with GATTEX, colonoscopy 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 children and adolescents, perform fecal occult blood testing prior to initiating treatment with GATTEX. Colonoscopy/sigmoidoscopy is required if there is unexplained blood in the stool. Perform subsequent fecal occult blood testing annually in children and adolescents while they are receiving GATTEX. Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after 1 year of treatment, every 5 years thereafter while on continuous treatment with GATTEX, and if they have new or unexplained gastrointestinal bleeding.

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 or Información de prescripción en español.

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Indication

GATTEX® (teduglutide) for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Important Safety Information

Warnings and Precautions
GATTEX has been associated with 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.

Indication
GATTEX® (teduglutide) for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older 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. In adults, within 6 months prior to starting treatment with GATTEX, colonoscopy 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 children and adolescents, perform fecal occult blood testing prior to initiating treatment with GATTEX. Colonoscopy/sigmoidoscopy is required if there is unexplained blood in the stool. Perform subsequent fecal occult blood testing annually in children and adolescents while they are receiving GATTEX. Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after 1 year of treatment, every 5 years thereafter while on continuous treatment with GATTEX, and if they have new or unexplained gastrointestinal bleeding.

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 or Información de prescripción en español.

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