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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Peggy is a real patient taking GATTEX


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 (PS). GATTEX is proven to enhance the absorptive capacity of the remaining bowel.1

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Short Bowel Syndrome is a rare, serious and chronic malabsorption disorder3

SBS is characterized by an inability of the intestine to maintain protein-energy, fluid, electrolyte, and micronutrient balances, despite being on a conventionally accepted, normal diet. SBS is typically due to an extensive intestinal resection.4

Malabsorption puts patients at risk for diarrhea, dehydration, electrolyte disturbances, and malnutrition.3,5

SBS in adults can have a functional or anatomical origin, often leading to surgical resection of the bowel3,7

Possible causes of bowel resection:

  • Crohn’s disease7
  • Vascular events (e.g., embolism/thrombosis)7
  • Complications of bariatric surgery5
  • Trauma7
  • Malignancy7
  • Volvulus7
  • Strangulated hernia8,9
  • Intestinal fistula8

Patients with SBS may have glucagon-like peptide-2 (GLP-2)-secreting L cells removed during a resection, which contributes to impaired intestinal adaptation.10-12,15

RESECTED intestine Resection intestine diagram
Normal intestine Normal intestine diagram

Endogenous GLP-2 secretion plays a critical role in the absorption of nutrients in the intestine13-17

  • GLP-2 secretion increases villus height and crypt depth16,17,24
  • Increases intestinal and portal blood flow1,18,19
  • Inhibits gastric acid secretion1,18,19

GATTEX is the first and only FDA-approved analog of human GLP-21,20

  • A GLP-2 analog with a single second-position amino acid substitution (alanine to glycine)1,13,21
  • Mimics the actions of naturally occurring human GLP-21

GATTEX increased surface area in the remaining bowel and enhanced absorption1

— Enhanced gastrointestinal fluid (wet weight) absorption by ~750 to 1000 mL/day1

Pharmacodynamics study

The ability of GATTEX to improve intestinal absorption was studied in 17 adult patients with SBS using daily doses of 0.03, 0.10, and 0.15 mg/kg (N=2-3 per dose group)a in a 21-day, open-label, multicenter, dose-ranging study. All subcutaneous (abdomen) doses studied, except 0.03 mg/kg once-daily, resulted in enhanced gastrointestinal fluid (wet weight) absorption and increased villus height and crypt depth of the intestinal mucosa.1

aThe recommended once-daily dose of GATTEX is 0.05 mg/kg. Reduce the dose by 50% in patients with moderate and severe renal impairment (creatinine clearance <50 mL/min) and end-stage renal disease.1

See Prescribing Information for Dosing and Administration.

Increased villus height
Increased crypt depth



GATTEX significantly reduced weekly parenteral supportb volume (STEPS)1

  • More than twice as many patients taking GATTEX had a clinical response in 6 months: 63% (27/43) for GATTEX vs 30% (13/43) for placebo compared to baseline (P=0.002)1
  • STEPS (Study 1 in Prescribing Information)
    • STEPS was a 6-month, randomized, double-blind, placebo-controlled, multicenter clinical trial of adult SBS patients dependent on parenteral support ≥3 times/week for ≥12 months1
    • The primary efficacy endpoint was based on a clinical response defined as a ≥20% reduction in weekly parenteral support volume from baseline (immediately before randomization) to both Weeks 20 and 241

bParenteral support refers to parenteral nutrition and/or essential fluids.2


GATTEX showed a long-term clinical response (STEPS2)1

  • cOf the 39 placebo patients who entered STEPS2, 29 completed 24 months of treatment with GATTEX.
  • dOf the 37 GATTEX patients from STEPS who entered STEPS2, 30 completed 30 months of treatment with GATTEX.1
Weekly parenteral support volume graph

In the 30-month exposure group:

  • 96% (21/22) of the responders in STEPS who went on to complete STEPS2 sustained their response to GATTEX1
  • 7 out of 8 nonresponders in STEPS achieved a clinical response in STEPS2 at 30 months1

STEPS2 (Study 2 in Prescribing Information)

  • 97% (76/78) of patients who completed STEPS elected to enroll in STEPS2 (n=37, GATTEX; n=39, placebo). STEPS2 was a 24-month, open-label extension study. All patients (N=88), including 12 who were never in STEPS, received GATTEX in STEPS2. Clinical response was defined as a ≥20% reduction in weekly parenteral support volume from baseline1

GATTEX increased the day(s) off of parenteral support from baseline1

  • 54% of patients on GATTEX (21/39) achieved at least a one-day-per-week reduction in parenteral support vs. 23% on placebo (9/39) in the 6-month study (STEPS)1,e
  • 70% of patients on GATTEX (21/30) for 30 months achieved at least
    one-day-per-week reduction in parenteral support in STEPS followed by STEPS2

eAfter randomization of the intent-to-treat population (N=86), 4 patients in the GATTEX arm and 4 patients in the placebo arm discontinued treatment, leaving 78 evaluable patients.2

Days on parenteral graph

GATTEX helped some patients achieve complete independence from parenteral support1

  • No patients were completely independent of the need for parenteral support at 6 months in STEPS2
Parenteral support clinical study results

33% of patients (10/30) were completely independent of the need for PS while on GATTEX treatment for 30 months.1

Days off parenteral support may allow patients more freedom for pastimes, sleep and rest, work or social interaction.2,5,22,23

is a real patient taking GATTEX.

GATTEX Safety profile in clinical studies

Adverse reactions in ≥5% of GATTEX-treated SBS patients and
more frequent than placebo: Studies 1 and 31

GATTEX 0.05 mg/kg/day (N=77) n (%) Placebo (N=59) n (%)
Abdominal pain 29 (37.7) 16 (27.1)
Upper respiratory tract infection 20 (26.0) 8 (13.6)
Nausea 19 (24.7) 12 (20.3)
Abdominal distension 15 (19.5) 1 (1.7)
Vomiting 9 (11.7) 6 (10.2)
Fluid overload 9 (11.7) 4 (6.8)
Flatulence 7 (9.1) 4 (6.8)
Hypersensitivity 6 (7.8) 3 (5.1)
Appetite disorders 5 (6.5) 2 (3.4)
Sleep disturbances 4 (5.2) 0
Cough 4 (5.2) 0
Skin hemorrhage 4 (5.2) 1 (1.7)
Patients with stoma
Gastrointestinal stoma complication 13 (41.9)f 3 (13.6)f

fPercentage based on 53 patients with a stoma (n=31, GATTEX 0.05 mg/kg/day; n=22, placebo).1

If patients have a stoma, advise them that, while they may experience abdominal pain and swelling of their stoma, especially when starting therapy with GATTEX, if they experience symptoms of intestinal obstruction, they should contact their physician.1

Many of these adverse reactions have been reported in association with the underlying disease and/or parenteral nutrition.1

Resources for healthcare professionals

Download the Start Form (callout)

Download the Start Form

To prescribe GATTEX, complete the Start Form available below. Filling out this form also registers your eligible patients with OnePath®, a product support program available to patients.

Download Now
See the steps to starting patients on GATTEX (callout)

See the steps to starting patients on GATTEX

This brochure walks you through the steps you need to take to prescribe GATTEX and explains how OnePath, a product support program, works with eligible patients to assist in accessing treatment as prescribed.

Download Now
Download a GATTEX Dosage table (callout)

Download a GATTEX Dosage Table

This helpful tool provides calculations for a range of weights (90—200 lbs). Download and print a copy to keep on hand.

  • The recommended once-daily dose of GATTEX is 0.05 mg/kg1
  • Renal impairment: reduce the dose of GATTEX by 50% in patients with moderate and severe renal impairment (creatinine clearance less than 50 mL/min) and end-stage renal disease (ESRD)1
  • Milliliter dosing is calculated by dividing the weight of the patient (kg) by 200
  • Across all clinical trials 21.8% (130/595) of patients experienced an injection-site reaction
Download Now
Continue learning about the importance of GLP-2 (callout)

Continue learning about the importance of GLP-2

This brochure explores the critical role of GLP-2 in the intestines and explains how GATTEX works.

Download Now
PN/IV support protocol (callout)

Weaning PN/IV support

This resource provides an overview of the weaning protocol from GATTEX clinical trials, STEPS and STEPS2.

Download Now


OnePath Patient Support Manager
OnePath, Shire’s patient assistance program logo

Product support for your patients

When patients begin treatment with GATTEX, eligible patients can also be enrolled in OnePath, Shire's product support program. OnePath works with your patients to make sure they are able to access their prescribed therapy. OnePath also provides ongoing product support services, including educational resources throughout their journey with Shire therapy.

Each eligible patient is supported by his or her own Patient Support Manager, Onboarding and Access Specialist, and Nurse Educator. This team can assist with several aspects related to treatment, including:

  • Understanding insurance coverage
  • Co-pay assistance
  • Injection training
  • In-home product delivery

Questions about GATTEX?

For more information about GATTEX, sign up to receive email updates and request a visit from a representative.

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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 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.


  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.