Starting patients on GATTEX

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

The purpose of GATTEX REMS is to inform healthcare providers and patients 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 www.gattexrems.com. REMS materials are also available through your GATTEX representative.

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Counsel your patient

Please share the appropriate REMs materials with your patients, 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 www.gattexrems.com

Please ensure the patient 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 the Guidance for Patients resource to provide more information about available OnePath 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
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Submit the OnePath® Start Form with signed patient consent

The Start Form serves as the prescription for GATTEX and enrolls your patients in OnePath.

  • OnePath provides product support services to eligible patients prescribed GATTEX, including arranging specialty pharmacy ordering and providing a dedicated PSM, OAS, and Nurse Educator. 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 patient or caregiver has completed the patient information section of the Start Form and that they've read the OnePath authorization and consent form
  • Both patient and prescriber signatures are required to authorize this form. If your patient is unable to make it into the office to sign the form, OnePath can obtain their consent via alternate methods. If you have any questions about the consent process, please contact your Takeda representative

OnePath Start Forms are available here, through your Takeda representative, or by calling 1-866-888-0660.

  • Fax the completed Start Forms to 1-855-369-3393
  • Please be aware the Start Form is not an insurance prior authorization form
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Perform safety assessments within 6 months prior to starting GATTEX treatment

In adult patients:
  • Perform a colonoscopy of the entire colon with removal of polyps
  • Obtain baseline laboratory assessment (bilirubin, alkaline phosphatase, lipase, and amylase)


For additional adult monitoring timelines, see here.

In children ≥1 year of age:
  • Perform fecal occult blood testing; if there is unexplained blood in the stool, perform colonoscopy/sigmoidoscopy
  • Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase, and amylase)

For additional pediatric monitoring timelines, see here.

Adult Monitoring Timeline

6 months icon

Within 6 months prior to starting GATTEX treatment1:

  • Perform a colonoscopy of the entire colon with removal of polyps1
  • Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase, and amylase)1
OngoingEvery 6 monthsAfter 1 year of Gattex*At least every 5 years
Colonoscopy after 1 year of GATTEX and at least every 5 years 1*1Examination of the entire colon with removal of polyps  XX
Laboratory Assessments every 6 months1Bilirubin X  
Alkaline phosphatase X  
Lipase X  
Amylase X  
Ongoing Clinical Evaluations1Signs and symptoms of intestinal obstructionX   
Signs and symptoms of fluid imbalance and fluid overloadX   
Increased absorption of concomitant medication(s)X   
Observation of other adverse eventsX   

Discontinuation of treatment with GATTEX may also result in fluid and electrolyte imbalance. Monitor fluid and electrolyte status in pediatric patients who discontinue treatment with GATTEX.1

*
Follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of treatment with GATTEX.1

 

Pediatric Monitoring Timeline

6 months icon

Within 6 months prior to starting GATTEX treatment1:

  • Perform fecal occult blood testing; if there is unexplained blood in the stool, perform colonoscopy/sigmoidoscopy1
  • Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase, and amylase)1
OngoingEvery 6 monthsAfter 1 year of GattexEvery yearAt least every 5 years
Fecal occult blood test every year1Examine for unexplained blood in stool   X 
Colonoscopy / Sigmoidoscopy after 1 year of GATTEX and every 5 years thereafter1†Assess for colorectal polyps  X X
Laboratory Assessments every 6 months1Bilirubin X   
Alkaline phosphatase X   
Lipase X   
Amylase X   
Ongoing Clinical Evaluations1Signs and symptoms of intestinal obstructionX    
Signs and symptoms of fluid imbalance and fluid overloadX    
Increased absorption of concomitant medication(s)X    
Observation of other adverse eventsX    

Discontinuation of treatment with GATTEX may result in fluid and electrolyte imbalance. Fluid and electrolyte status should be monitored in patients who discontinue treatment with GATTEX.1

†
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.1

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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