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 gastrointestinal bleeding.
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 benefit-risk considerations.
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 reassessed.
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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de prescripción en español.