Reduced Day(s) on Parenteral Support
After 24 weeks of treatment, a total of 54% of patients on GATTEX® versus 23% on placebo achieved a reduction of 1 day or more per week of parenteral support*
The percentage of GATTEX-treated patients who reduced their days per week of parenteral support increased in all groups over time.
- 70% of patients who were treated with at least 30 months of GATTEX achieved a reduction of 1 day or more in parenteral support
- The majority (60%) of the 30 patients who received at least 30 months of GATTEX during STEPS and STEPS2 achieved a reduction of 3 days or more per week in parenteral support
- 10 out of 30 patients achieved complete independence from PS after 30 months of treatment with GATTEX
Hypothetical patient or doctor portrayal
* Parenteral support refers to parenteral nutrition and/or essential fluids.
STEPS was a 6-month randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter clinical trial (Study 1) in adults with SBS who were dependent on parenteral nutrition/intravenous (PN/I.V.) support for at least 12 months and required PN at least 3 times per week. For 8 weeks (or less) prior to randomization, investigators optimized the PN/I.V. volume of all subjects. Optimization was followed by a 4-week to 8-week period of fluid stabilization. Subjects then were randomized (1:1) to placebo (n=43) or GATTEX 0.05 mg/kg/day (n=43). Study treatment was administered subcutaneously once daily for 24 weeks. PN/I.V. volume adjustments (up to 30% decrease) and clinical assessments were made at 2, 4, 8, 12, 20, and 24 weeks. STEPS2 was a 2-year open label extension of Study 1 in which 88 subjects received GATTEX 0.05 mg/kg/day.
1. GATTEX (teduglutide [rDNA origin]) [package insert]. Bedminster, NJ: NPS Pharmaceuticals, Inc.
2. Hofstetter S, Stern L, Willet J. Key issues in addressing the clinical and humanistic burden of short bowel syndrome in the US. Curr Med Res Opin. 2013;29(5):495-504.
3. Mullady DK, O’Keefe JD. Treatment of intestinal failure: home parenteral nutrition. Nat Clin Pract Gastroenterol Hepatol. 2006;3(9):492-504.
4. Winkler MF, Hagan E, Wetle T, et al. An exploration of quality of life and the experience of living with home parenteral nutrition. J Parenter Enteral Nutr. 2010;34(4):395-407.
Important Safety Information
Warnings and Precautions
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.
Biliary and pancreatic disease
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.
Increased absorption of concomitant oral medication
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).
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.
For additional safety information, please click here for Prescribing Information