Short Bowel Syndrome

Short bowel syndrome (SBS) is a serious and chronic malabsorption disorder.1,2

SBS is the result of physical loss and functional deficiency of portions of the intestine, primarily due to surgical resection2*

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

Malnutrition malabsorption icon

MALNUTRITION

water drop dehydration icon

DEHYDRATION

electrolyte disturbances wave icon

ELECTROLYTE 
DISTURBANCES

diarrhea increased outputs icon

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.
All patients who were included in the clinical trials described had previous bowel resections.
Peggy GATTEX patient walking

I was not at all prepared for life with SBS…I was experiencing life-threatening electrolyte and mineral imbalances…I was used to always looking for the nearest bathroom. Now, I was also looking for the nearest emergency room.”

-Peggy,
GATTEX PATIENT

Common causes of SBS

SBS can have a functional or anatomical origin, leading to bowel resection6

The possible pathophysiologies, underlying diseases, or congenital conditions can vary between adult and pediatric patients6-8

ADULT PATIENTS ICON

IN ADULT PATIENTS6-9

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

GATTEX in Adults

Pediatric Patient Icon

IN PEDIATRIC PATIENTS10,11

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

GATTEX in PEDIATRICS ≥1 YEAR

Treatment goals for patients with SBS12

Management of SBS is complex and requires an individualized approach; treatment is typically determined by the following goals12:

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

A REDUCTION IN PS REQUIREMENTS MAY GIVE PATIENTS MORE FREEDOM FOR7,13‡:

freedom from parenteral support for short bowel syndrome patients activities charts

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.

When appropriate, attempts should be made to wean patients off of parenteral support (PS)13,14

Patients with SBS often require PS15

PS dependency can include a range of needs that can vary in nutritional components, frequency, and administration times.4

short bowel syndrome parenteral support chart short bowel syndrome parenteral support chart

Deliver hydration along with electrolytes and potentially other components (eg, D5/.45 NS, NS, LR)16

Provide balanced caloric energy needs and can include a variety of components, such as protein, fat, and sugar as well as electrolytes and vitamins. What separates PPN and TPN is route of administration. PPN is delivered through a peripheral line and TPN through a central line.17,18

PS is used to stabilize patients with SBS, but chronic use should be minimized, if possible.13,14,19

Long-term PS is associated with complications that can be serious and sometimes life-threatening.7,20

D5/.45 NS = dextrose 5% and 0.45% normal saline, LR = lactated Ringer's, NS = normal saline.

LONG-TERM PS DOES NOT INCREASE INTESTINAL ABSORPTION14

Native GLP-2 promotes intestinal absorption21-25

Glucagon-like peptide-2 (GLP-2) is an intestinal hormone that plays an important role in maintaining the structure and function of the intestine to facilitate absorption.26-28§

GLP-2 SECRETION HELPS:

Increase villus icon

Increase villus height and crypt depth24,25

apple nutrients icon

Facilitate absorption of nutrients21-25

up arrow icon

Increase intestinal and portal blood flow29-31

block Inhibit icon

Inhibit gastric acid secretion26,29,30

L
L cells are enteroendocrine cells that are generally located in the small intestine and colon.
Loop
GLP-2 is secreted by L cells in the intestine.
bowel anatomy, L-cells and GLP-2 illustration

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

GLP-2 secretion may be impacted in patients with SBS24

Patients with SBS may have limited GLP-2 secretion due to the removal of L cells following resections such as24:

intestinal resections may lead to short bowel syndrome

Jejunoileal
Anastomosis32

intestinal resections may lead to short bowel syndrome

Jejunocolonic
Anastomosis32

intestinal resections may lead to short bowel syndrome

End
Jejunostomy32

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 GLP-2 analog for patients with SBS who are dependent on PS29

GATTEX in Adults GATTEX in Pediatrics ≥1 YEAR

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.

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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, biliary and pancreatic disease, fluid imbalance and fluid overload, and increased absorption of concomitant oral medication. Click here for additional Important 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.

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