GATTEX is the first and only GLP-2 analog approved for adult patients with SBS who are dependent on PS1,2

How native GLP-2 works

Native GLP-2 secretion may be impacted in patients with SBS.3

Image of GLP-2 secretion illustration

Images are provided for illustrative purposes only

How native GLP-2 works

Native GLP-2 secretion may be impacted in patients with SBS.3

GLP-2 secretion:

Increase

Increases villus height and crypt depth4,5

Inhibits

Inhibits gastric acid secretion1,7

Increase

Increases intestinal and portal blood flow1,6,8

Absorption

Facilitates the absorption of nutrients4,5,9-11

The importance of GLP-2

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How GATTEX works

GATTEX increased the absorptive capacity of the intestine. GATTEX also increased intestinal villus height and crypt depth vs baseline.6

Image of GATTEX increased villus height and crypt depth illustration

Images are provided for illustrative purposes only

How GATTEX works

GATTEX increased the absorptive capacity of the intestine. GATTEX also increased intestinal villus height and crypt depth vs baseline.6

Pharmacodynamics study1

The ability of GATTEX to improve intestinal absorption was studied in 17 adult subjects with Short Bowel Syndrome (N=2‑3 per dose group) using daily doses of 0.03, 0.10, 0.15 mg/kg (doses ranging from 0.6 to 3 times the recommended dose)* in a 21‑day, open‑label, multi‑center, dose‑ranging study. All subcutaneous (abdomen) doses studied, except 0.03 mg/kg once daily, resulted in enhanced gastrointestinal fluid (wet weight) absorption of approximately 750 to 1000 mL/day, and increased villus height and crypt depth of the intestinal mucosa.

*The recommended once-daily dose of GATTEX is 0.05 mg/kg. The recommended dosage in patients with moderate and severe renal impairment and end‑stage renal disease (creatinine clearance <60 mL/min) is 0.025 mg/kg once daily.1

Please see full Prescribing Information for complete Dosage and Administration information.

What could GATTEX do for your patients?

Efficacy & Safety

How do patients take GATTEX?

Gattex Dosing

Indication:
GATTEX® (teduglutide) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Important Safety Information:

Warnings and Precautions:
GATTEX has been associated with possible acceleration of neoplastic growth, intestinal obstruction, biliary and pancreatic disease, fluid imbalance and fluid overload, and increased absorption of concomitant oral medication. Click here for additional Important Safety Information.

Click here for additional Important Safety Information.

Indication

GATTEX® (teduglutide) for injection is indicated for the treatment of adult patients 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. Within 6 months prior to starting treatment with GATTEX, colonoscopy (or alternate imaging) 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 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

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.

Adverse Reactions

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.

Please click here for full Prescribing Information.

References:
  1. GATTEX (teduglutide) for injection [package insert]. Lexington, MA: Shire-NPS Pharmaceuticals, Inc; 2018.
  2. FDA approves Gattex to treat short bowel syndrome [press release]. Silver Spring, MD. U.S. Food and Drug Administration; December 21, 2012.
  3. Jeppesen PB, Hartmann B, Hansen BS, Thulesen J, Holst JJ, Mortensen PB. Gut. 1999; 45(4):559-563.
  4. Thomson ABR, Chopra A, Clandinin MT, Freeman H. World J Gastroenterol. 2012; 18(26):3353-3374.
  5. Rowland KJ, Brubaker PL. Am J Physiol Gastrointest Liver Physiol. 2011; 301; G1-G8.
  6. Jeppesen PB, Sanguinetti EL, Buchman A, et al. Gut. 2005;54(9):1224-1231.
  7. Tee CT, Wallis K, Gabe SM. Clin Exp Gastroenterol.2011;4:189-196.
  8. Dubé PE, Brubaker PL. Am J Physiol Endocrinol Metab. 2007;293(2):E460-E465.
  9. Tappenden KA, Edelman J, Joelsson B. J Clin Gastroenterol. 2013;47(7):602-607.
  10. Janssen P. Rotondo A, Mule F, Tack J. Allment Pharmacol Ther. 2013; 37:18-36.
  11. Brubaker PL, Anini Y. Can J Physiol Pharmacol. 2003;81(11):1005-1012.