GATTEX® (teduglutide [rDNA origin]) for Injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support (PS). GATTEX is proven to enhance the absorptive capacity of the remaining bowel.1
Sign up to receive email updatesSIGN UP
SBS is characterized by an inability of the intestine to maintain protein-energy, fluid, electrolyte, and micronutrient balances, despite being on a conventionally accepted, normal diet. SBS is typically due to an extensive intestinal resection.4
Malabsorption puts patients at risk for diarrhea, dehydration, electrolyte disturbances, and malnutrition.3,5
Patients with SBS may have glucagon-like peptide-2 (GLP-2)-secreting L cells removed during a resection, which contributes to impaired intestinal adaptation.10-12,15
— Enhanced gastrointestinal fluid (wet weight) absorption by ~750 to 1000 mL/day1
The ability of GATTEX to improve intestinal absorption was studied in 17 adult patients with SBS using daily doses of 0.03, 0.10, and 0.15 mg/kg (N=2-3 per dose group)a in a 21-day, open-label, multicenter, dose-ranging study. All subcutaneous (abdomen) doses studied, except 0.03 mg/kg once-daily, resulted in enhanced gastrointestinal fluid (wet weight) absorption and increased villus height and crypt depth of the intestinal mucosa.1
aThe recommended once-daily dose of GATTEX is 0.05 mg/kg. Reduce the dose by 50% in patients with moderate and severe renal impairment (creatinine clearance <50 mL/min) and end-stage renal disease.1
See Prescribing Information for Dosing and Administration.
bParenteral support refers to parenteral nutrition and/or essential fluids.2
eAfter randomization of the intent-to-treat population (N=86), 4 patients in the GATTEX arm and 4 patients in the placebo arm discontinued treatment, leaving 78 evaluable patients.2
33% of patients (10/30) were completely independent of the need for PS while on GATTEX treatment for 30 months.1
Days off parenteral support may allow patients more freedom for pastimes, sleep and rest, work or social interaction.2,5,22,23
|GATTEX 0.05 mg/kg/day (N=77) n (%)||Placebo (N=59) n (%)|
|Abdominal pain||29 (37.7)||16 (27.1)|
|Upper respiratory tract infection||20 (26.0)||8 (13.6)|
|Nausea||19 (24.7)||12 (20.3)|
|Abdominal distension||15 (19.5)||1 (1.7)|
|Vomiting||9 (11.7)||6 (10.2)|
|Fluid overload||9 (11.7)||4 (6.8)|
|Flatulence||7 (9.1)||4 (6.8)|
|Hypersensitivity||6 (7.8)||3 (5.1)|
|Appetite disorders||5 (6.5)||2 (3.4)|
|Sleep disturbances||4 (5.2)||0|
|Skin hemorrhage||4 (5.2)||1 (1.7)|
|Patients with stoma|
|Gastrointestinal stoma complication||13 (41.9)f||3 (13.6)f|
fPercentage based on 53 patients with a stoma (n=31, GATTEX 0.05 mg/kg/day; n=22, placebo).1
If patients have a stoma, advise them that, while they may experience abdominal pain and swelling of their stoma, especially when starting therapy with GATTEX, if they experience symptoms of intestinal obstruction, they should contact their physician.1
Many of these adverse reactions have been reported in association with the underlying disease and/or parenteral nutrition.1
To prescribe GATTEX, complete the Start Form available below. Filling out this form also registers your eligible patients with OnePath®, a product support program available to patients.Download Now
This brochure walks you through the steps you need to take to prescribe GATTEX and explains how OnePath, a product support program, works with eligible patients to assist in accessing treatment as prescribed.Download Now
This helpful tool provides calculations for a range of weights (90—200 lbs). Download and print a copy to keep on hand.
This brochure explores the critical role of GLP-2 in the intestines and explains how GATTEX works.Download Now
This resource provides an overview of the weaning protocol from GATTEX clinical trials, STEPS and STEPS2.Download Now
When patients begin treatment with GATTEX, eligible patients can also be enrolled in OnePath, Shire's product support program. OnePath works with your patients to make sure they are able to access their prescribed therapy. OnePath also provides ongoing product support services, including educational resources throughout their journey with Shire therapy.
Each eligible patient is supported by his or her own Patient Support Manager, Onboarding and Access Specialist, and Nurse Educator. This team can assist with several aspects related to treatment, including:
Colorectal polyps were identified during clinical trials. There is a risk for acceleration of neoplastic growth. Colonoscopy of the entire colon with removal of polyps should be done within 6 months prior to starting treatment with GATTEX and is recommended after 1 year. Subsequent colonoscopies should be done as needed, but no less frequently than every 5 years. 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 risk and benefit considerations.
Intestinal obstruction has been reported in clinical trials. In patients who develop obstruction, GATTEX should be temporarily discontinued pending further clinical evaluation and management.
Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported in clinical trials. Patients should undergo laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) before starting GATTEX. Subsequent laboratory tests should be done every 6 months. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and continued treatment with GATTEX should be reassessed.
Fluid overload and congestive heart failure have been observed in clinical trials. There is potential for fluid overload while on GATTEX. If fluid overload occurs, especially in patients with underlying cardiovascular disease, parenteral support should be appropriately adjusted and GATTEX treatment reassessed.
Altered mental status in association with GATTEX has been observed in patients on benzodiazepines in clinical trials. Patients on concomitant oral drugs (e.g. benzodiazepines, phenothiazines) requiring titration or with a narrow therapeutic index may require dose adjustment while on GATTEX.
The most common adverse reactions (≥10%) across all studies with GATTEX are abdominal pain, injection site reactions, nausea, headaches, abdominal distension, upper respiratory tract infection. In addition, vomiting and fluid overload were reported in the SBS studies (1 and 3) at rates ≥10%.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You can also call Shire at 1‑855‑5GATTEX (1-855-542-8839).
For additional safety information, please click here for Prescribing Information.
GATTEX (teduglutide [rDNA origin]) 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 and enhanced growth of colon polyps, gastrointestinal obstruction, gallbladder, biliary tract and pancreatic disease, increased absorption of fluids leading to fluid overload, and increased absorption of oral medicines.
Click here for additional Important Safety Information.