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Important Safety Information: GATTEX may cause serious side effects including making abnormal cells grow faster, polyps in the colon (large intestine), blockage of the bowels (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload. Click here for additional Important Safety Information.

Proven Efficacy

Overview of STEPS and STEPS2 Results

Patients who continued the trial showed evidence of increased response to treatment in terms of parenteral support volume reductions, days off parenteral support, and complete weaning of parenteral support.

The primary efficacy endpoint was based on a clinical response defined as a patient achieving at least a 20% reduction in weekly parenteral support volume from baseline (immediately before randomization) to both Weeks 20 and 24.

Clinical Response to GATTEX® during STEPS and STEPS2

More than twice as many patients on GATTEX® had a response to treatment at 24 weeks1

In the STEPS trial, 63% (27/43) of patients had a response to GATTEX versus 30% (13/43) to placebo (P=0.002)

The primary efficacy endpoint was based on a clinical response defined as a patient achieving at least a 20% reduction in weekly parenteral support volume from baseline (immediately before randomization) to both Weeks 20 and 24

Most patients continued to respond to GATTEX treatment in the 2-year extension study STEPS21

96% (21/22) of responders in STEPS who entered STEPS2 sustained their response to GATTEX

The percentage of patients who responded to treatment increased in all groups over time1

93% (28/30) of patients who received GATTEX both in STEPS and STEPS2 for a total of 30 months had a response to GATTEX

* Parenteral support refers to parenteral nutrition and/or essential fluids.

Reference:
1. GATTEX (teduglutide [rDNA origin]) [package insert]. Bedminster, NJ: NPS Pharmaceuticals, Inc., a wholly-owned, indirect subsidiary of Shire North American Group, Inc.

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.

 

Important Safety Information

Warnings and Precautions

Neoplastic growth
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
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
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.

Adverse Reactions
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