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
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
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
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.
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.
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Información de prescripción en español.