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. Important Safety Information Full Prescribing Information Medication Guide Instructions for Use Information for Patients

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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).

For additional safety information, please click here for Prescribing Information.

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.

References:

  1. 1. GATTEX (teduglutide [rDNA origin]) for Injection [package insert]. Bedminster, NJ: Shire-NPS Pharmaceuticals, Inc.
  2. 2. Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012;143(6):1473-1481.
  3. 3. Seidner DL, Schwartz LK, Winkler MF, Jeejeebhoy K, Boullata JI, Tappenden KA. Increased intestinal absorption in the era of teduglutide and its impact on management strategies in patients with short bowel syndrome-associated intestinal failure. JPEN J Parenter Enteral Nutr. 2013;37(2):201-211.
  4. 4. O'Keefe SJ, Buchman AL, Fishbein TM, Jeejeebhoy KN, Jeppesen PB, Shaffer J. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol. 2006;4(1):6-10.
  5. 5. 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.
  6. 6. Buchman AL. Etiology and initial management of short bowel syndrome. Gastroenterol. 2006;130(2 Suppl 1):S5-S15.
  7. 7. Buchman AL, Scolapio J, Fryer J. AGA technical review on short bowel syndrome and intestinal transplantation. Gastroenterology. 2003;124(4):1111-1134.
  8. 8. Pironi L, Arends J, Baxter J, et al. ESPEN endorsed recommendations. Definition of classification of intestinal failure in adults. Clin Nutr. 2015;34(2):171-180.
  9. 9. Parrish CR. The Clinician's Guide to Short Bowel Syndrome. Pract Gastroenterol. 2005;XXIX(9):67-106.
  10. 10. Jeppesen PB, Hartmann B, Hansen BS, Thulesen J, Holst JJ, Mortensen PB. Impaired meal stimulated glucagon-like peptide 2 response in ileal resected short bowel patients with intestinal failure. Gut. 1999;45(4):559-563.
  11. 11. Jeppesen PB, Hartmann B, Thulesen J, et al. Elevated plasma glucagon-like peptide 1 and 2 concentrations in ileum resected short bowel patients with a preserved colon. Gut. 2000;47(3):370-376.
  12. 12. Jeppesen PB, Hartmann B, Thulesen J, et al. Glucagon-like peptide 2 improves nutrient absorption and nutritional status in short-bowel patients with no colon. Gastroenterology. 2001;120(4):806-815.
  13. 13. Tappenden KA, Edelman J, Joelsson B. Teduglutide enhances structural adaptation of the small intestinal mucosa in patients with short bowel syndrome. J Clin Gastroenterol. 2013;47(7):602-607.
  14. 14. Janssen P, Rotondo A, Mulé F, Tack J. Review article: a comparison of glucagon-like peptides 1 and 2. Aliment Pharmacol Ther. 2013;37(1):18-36.
  15. 15. Brubaker PL, Anini Y. Direct and indirect mechanisms regulating secretion of glucagon-like peptide-1 and glucagon-like peptide-2. Can J Physiol Pharmacol. 2003;81(11):1005-1012.
  16. 16. Thomson AB, Chopra A, Clandinin MT, Freeman H. Recent advances in small bowel diseases: Part II. World J Gastroenterol. 2012;18(26):3353-3374.
  17. 17. Rowland KJ, Brubaker PL. The "cryptic" mechanism of action of glucagon-like peptide-2. Am J Physiol Gastrointest Liver Physiol. 2011;301(1): G1-G8.
  18. 18. Jeppesen PB, Sanguinetti EL, Buchman A, et al. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005;54(9):1224-1231.
  19. 19. Dubé PE, Brubaker PL. Frontiers in glucagon-like peptide-2: multiple actions, multiple mediators. Am J Physiol Endocrinol Metab. 2007;293(2):E460-E465.
  20. 20. FDA approves Gattex to treat short bowel syndrome [press release]. Silver Spring, MD. U.S. Food and Drug Administration; December 21, 2012.
  21. 21. Tavares W, Drucker DJ, Brubaker PL. Enzymatic- and renal-dependent catabolism of the intestinotropic hormone glucagon-like peptide-2 in rats. Am J Physiol Endocrinol Metab. 2000;278(1):E134-E139.
  22. 22. Vipperla K, O'Keefe SJ. Teduglutide for the treatment of short bowel syndrome. Expert Rev Gastroenterol Hepatol. 2011;5(6):665-678.
  23. 23. Schwartz LK, O'Keefe SJ, Fujioka K, et al. Long-term teduglutide for the treatment of patients with intestinal failure associated with short bowel syndrome. Clin Transl Gastroenterol. 2016;7:e142.
  24. 24. Martin GR, Wallace LE, Hartmann B, et al. Nutrient-stimulated GLP-2 release and crypt cell proliferation in experimental short bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2004;288(3):G431-G438.

Important Safety Information
Warnings and Precautions: GATTEX has been associated with possible acceleration of neoplastic growth and enhanced growth of colon polyps, gastrointestinal obstruction, gallbladder, biliary tract and pancreatic disease, increased absorption of fluids leading to fluid overload, and increased absorption of oral medicines.
Click here for additional Important Safety Information.