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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.

Risk Evaluation and Mitigation Strategy

 The FDA has required a REMS for GATTEX® (teduglutide [rDNA origin]) for Injection

Hypothetical patient portrayal

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has required a REMS for GATTEX®.

The purpose of the GATTEX REMS is to inform healthcare providers and patients about the following risks:

• Possible acceleration of neoplastic growth and enhancement of colon polyp growth

• Gastrointestinal obstruction

• Biliary and pancreatic disorders

Prescribers who intend to treat patients with GATTEX should review the education materials that are part of the REMS.

 

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