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short bowel syndrome (SBS)

SBS is a serious and chronic malabsorption disorder.1,2

Short bowel syndrome (SBS) is the result of physical loss and functional deficiency of portions of the intestine, primarily due to surgical resection2*

The malabsorption spectrum of SBS is wide, and clinical features include1,3,4:

MALNUTRITION

DEHYDRATION

ELECTROLYTE 
DISTURBANCES

DIARRHEA / INCREASED
OUTPUTS

Patients with SBS are heterogeneous because of large variations in intestinal function and remnant bowel anatomy.5

SBS is a condition characterized by a collection of clinical features, not only length of remaining bowel.5

*Patients with SBS require varying fluid/nutritional interventions based on individual needs.

Finding something that works for you might take time and effort, but in the end, it's worth it. ”

Peggy,
GATTEX PATIENT

Short bowel syndrome (SBS) can have a functional or anatomical origin6

Possible pathophysiologies, underlying diseases, or congenital conditions that can lead to SBS6-8

Common causes of short bowel syndrome (SBS):

This is not a complete list of causes for SBS.

ADULT PATIENTS6-9

  • Vascular events (eg, embolism, thrombosis)
  • Crohn's disease
  • Complications from bariatric surgery
  • Malignancy
  • Trauma
  • Volvulus
  • Strangulated hernia
  • Small bowel fistulas
  • Ulcerative colitis

GATTEX in Adults

PEDIATRIC PATIENTS10,11

  • Necrotizing enterocolitis
  • Gastroschisis
  • Midgut volvulus
  • Malrotation
  • Intestinal atresia
  • Intestinal aganglionosis
  • Trauma
  • Hirschsprung's disease
  • Crohn's disease

GATTEX in PEDIATRICS ≥1 YEAR

Patients with SBS may go undiagnosed due to underreporting and the lack of reliable patient databases.12

Management of short bowel syndrome (SBS) is complex and requires an individualized approach13

Important treatment goals for patients with SBS13:

A multidisciplinary team approach, which may consist of physicians, surgeons, nurses, dietitians, and/or social workers, may contribute to the success of achieving patients’ treatment goals.14

  • Maintain adequate nutrition and hydration requirements
  • Reduce or eliminate the need for parenteral support (PS) and increase oral and/or enteral feeding
  • Promote intestinal adaptation
  • Minimize disease- and parenteral support (PS)-related complications

Patients with short bowel syndrome (SBS) often require parenteral support (PS)15

PS dependency can vary in nutritional components, frequency, and administration times.4

Less Nutrients

Intravenous (IV) fluids16

Delivers hydration along with electrolytes and potentially other components (ie, dextrose 5% and 0.45%, normal saline, lactated ringer’s).

More Nutrients

Parenteral nutrition17,18

Provides balanced caloric energy needs and can include a variety of components, such as protein, fat, and sugar, as well as electrolytes and vitamins.

  • Peripheral Parenteral Nutrition (PPN) Delivered through a peripheral line
  • Total Parenteral Nutrition (TPN) Delivered through a central venous line

When appropriate, attempts should be made to wean patients with SBS off parenteral support (PS)19,20

PS is lifesaving for patients with SBS, but long-term use should be minimized19-22

  • PS does not increase intestinal absorption23
  • Long-term use of PS is associated with numerous complications that can be serious and sometimes life-threatening, such as1,7,24‡:

Hepatobiliary diseases (ie, intestinal failure-associated liver disease [IFALD] and gallstones)

Kidney diseases (ie, hyperoxaluria)

Metabolic bone diseases (ie, osteoporosis)

Central venous complications (ie, septic infections, thrombosis, and loss of vascular access)

The effects of GATTEX (teduglutide) on these complications were not studied.

A reduction in parenteral support (PS) requirements may give patients more freedom for7,19§:

Work
School
Sleep and rest
Hobbies

§Examples of how some patients may spend their time if they are able to achieve a reduction in PS requirements are for illustrative purposes only.
Patients should always discuss their individual medical circumstances and activities with their doctor.

Glucagon-like peptide-2 (GLP-2) plays an important role in intestinal absorption25-29

GLP-2 is a naturally occurring hormone that plays a role in maintaining the structure and function of the intestine to facilitate absorption.30-32¶

GLP-2 secretion helps:

Increase villus height and crypt depth28,29

Facilitate absorption of nutrients25-29

Increase intestinal and portal blood flow33,34

Inhibit gastric acid secretion29,33,35

Based on studies in animals and healthy volunteers; the clinical relevance of these data has not been established.

Patients with short bowel syndrome (SBS) have reduced intestinal absorption28

Patients with SBS may have limited GLP-2 secretion due to the removal of L cells following resections28:

Any resection can impact GLP-2 secretion resulting in SBS#

L cells are enteroendocrine cells that are generally located in the small intestine and colon.

GLP-2 is secreted by L cells in the intestine.

L cells and GLP-2 in jejunoileal anastomosis Jejunoileal
anastomosis23
L cells and GLP-2 in jejunocolonic anastomosis jejunocolonic
anastomosis23
L cells and GLP-2 in end jejunostomy end
jejunostomy23

#This is not a comprehensive list of bowel resections.

Images are for illustrative purposes only. GLP-2 secretion after resection will vary, and different anatomies may lead to SBS.

Learn more about GATTEX, the first and only FDA-approved analog of naturally occurring GLP-2 for patients with SBS who are dependent on PS35

GATTEX in Adults GATTEX in Pediatrics ≥1 YEAR

  1. Jeppesen PB. JPEN J Parenter Enteral Nutr. 2014;38(suppl 1):8S-13S.
  2. O'Keefe SJ et al. Clin Gastroenterol Hepatol. 2006;4(1):6-10.
  3. Thompson JS et al. Surg Clin North Am. 2011;91(3):493-510.
  4. Seidner DL et al. JPEN J Parenter Enteral Nutr. 2013;37(2):201-211.
  5. Pironi L et al. Clin Nutr. 2015;34(2):171-180.
  6. Buchman AL et al. Gastroenterology. 2003;124(4):1111-1134.
  7. Hofstetter S et al. Curr Med Res Opin. 2013;29(5):495-504.
  8. Parrish CR. Pract Gastroenterol. 2005;29(9):67-106.
  9. Thompson JS et al. J Gastrointest Surg. 2008;12:73–76.
  10. Wales PW, Christison-Lagay ER. Semin Pediatr Surg. 2010;19(1):3-9.
  11. Duggan CP, Jaksic T. N Engl J Med. 2017;377(7):666-675.
  12. Massironi S, Cavalcoli F, Rausa E, et al. Dig Liver Dis. 2020;52(3):253-261.
  13. Kelly DG et al. JPEN J Parenter Enteral Nutr. 2014;38(4):427-437.
  14. Matarese LE et al. JPEN J Parenter Enteral Nutr. 2014;38(suppl 1):60S-64S
  15. Matarese LE. JPEN J Parenter Enteral Nutr. 2013;37(2):161-170.
  16. Hoorn EJ. J Nephrol. 2017; 30(4):485–492.
  17. Lappas BM et al. Gastroenterol Clin North Am. 2018;47(1):39-59.
  18. Bohl CJ et al. Ann Pharmacother. 2017;51(7):603-613.
  19. Vipperla K, O’Keefe SJ. Expert Rev Gastroenterol Hepatol. 2011;5(6):665-678.
  20. Jeppesen PB et al. Gut. 2011;60(7):902-914.
  21. DiBaise JK, Matarese LE, Messing B, Steiger E. J Clin Gastroenterol. 2006;40(Suppl 2):S94-S98.
  22. Buchman AL. Short Bowel Syndrome. In: Feldman M, Friedman L, Brandt L. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease. Pathophysiology, Diagnosis, Management. 10th ed. 2015;1832-1848.
  23. Tappenden KA. JPEN J Parenter Enteral Nutr. 2014;38(suppl 1):23S-31S.
  24. Mullady DK, O’Keefe SJ. Nat Clin Pract Gastroenterol Hepatol. 2006;3(9):492-504.
  25. Tappenden KA et al. J Clin Gastroenterol. 2013;47(7):602-607.
  26. Janssen P et al. Aliment Pharmacol Ther. 2013;37(1):18-36.
  27. Brubaker PL, Anini Y. Can J Physiol Pharmacol. 2003;81(11):1005-1012.
  28. Thomson ABR et al. World J Gastroenterol. 2012;18(26):3353-3374.
  29. Rowland KJ, Brubaker PL. Am J Physiol Gastrointest Liver Physiol. 2011;301(1):G1-G8.
  30. Tee CT et al. Clin Exp Gastroenterol. 2011;4:189-196.
  31. Drucker DJ, Yusta B. Annu Rev Physiol. 2014;76:561-583.
  32. Wallis K et al. Curr Opin Clin Nutr Metab Care. 2009;12(5):526-532.
  33. Jeppesen PB et al. Gut. 2005;54(9):1224-1231.
  34. Dube PE, Brubaker PL. Am J Physiol Endocrinol Metab. 2007;293:E460–E465.
  35. GATTEX (teduglutide) for injection [package insert]. Lexington, MA: Shire-NPS Pharmaceuticals, Inc.
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INDICATION

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
Gattex has been associated with acceleration of neoplastic growth, intestinal obstruction, billary and pancreatic disease, fluid imbalance and fluid overload, and increased absorption of concomitant oral medication. Click here for additional Safety Information.

INDICATION
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
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 or Información de prescripción en español.