Teduglutide

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow and inhibit gastric acid secretion.

• GATTEX ® 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 . GATTEX ® is a glucagon-like peptide-2 (GLP-2) analog 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.

• None. None.contraindicated

Important Administration Information GATTEX is for adult self-administration or caregiver administration. Self-administration in pediatric patients has not been tested. Use of the GATTEX 5 mg kit is not recommended in pediatric patients weighing less than 10 kg. ( 2.1 ) Evaluation Testing within 6 Months Prior to Starting GATTEX Adult Patients : Perform a colonoscopy and upper GI endoscopy with removal of polyps. ( 2.1 , 5.1 ) Pediatric Patients : Perform fecal occult blood testing. If new or unexplained blood in the stool, perform colonoscopy/sigmoidoscopy and upper GI endoscopy. ( 2.1 , 5.1 ) Adult and Pediatric Patients : Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase and amylase). ( 2.1 , 5.3 ) Dosage and Administration For subcutaneous use only. ( 2.2 ) The recommended dosage of GATTEX for both adults and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection. ( 2.2 ) Alternate sites between 1 of the 4 quadrants of the abdomen, or into alternating thighs or alternating arms. ( 2.2 ) Dosage Adjustment for Renal Impairment For adult and pediatric patients with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate less than 60 mL/min/1.73 m 2 ) the recommended dosage is 0.025 mg/kg once daily. ( 2.3 ) Discontinuation When treatment is discontinued, monitor for fluid and electrolyte imbalances. ( 2.5 , 5.4 ) Preparation See full prescribing information for instructions on reconstitution.

Acceleration of Neoplastic Growth : In case of intestinal malignancy, discontinue GATTEX. The decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on benefit risk considerations. ( 5.1 ) In adult patients, colonoscopy and upper GI endoscopy (or alternate imaging) is recommended after 1 year of treatment. Perform subsequent colonoscopies and upper GI endoscopes (or alternate imaging) no less frequently than every 5 years. ( 5.1 ) In pediatric patients, perform fecal occult blood testing annually. Colonoscopy/sigmoidoscopy is recommended after 1 year of treatment and every 5 years thereafter on treatment. Consider upper GI endoscopy (or alternate imaging) during treatment with GATTEX. ( 5.1 ) Intestinal Obstruction : In patients who develop intestinal or stomal obstruction, temporarily discontinue GATTEX pending further clinical evaluation and management. ( 5.2 ) Biliary and Pancreatic Disease : Obtain bilirubin, alkaline phosphatase, lipase, amylase every 6 months. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and reassess continued GATTEX treatment. ( 5.3 ) Fluid Overload, Including Congestive Heart Failure : If fluid overload occurs, adjust parenteral support, and reassess continued GATTEX treatment. ( 5.4 ) Potential for Increased Absorption of Oral Medications : Monitor patients on concomitant oral medications (e.g., benzodiazepines) for adverse reactions related to the concomitant drug; dosage reduction of the other drug may be required.

The following serious adverse reactions are described elsewhere in the labeling: Acceleration of Neoplastic Growth [see Warnings and Precautions ( 5.1 )] Intestinal Obstruction [see Warnings and Precautions ( 5.2 )] Biliary and Pancreatic Disease [see Warnings and Precautions ( 5.3 )] Fluid Imbalance and Fluid Overload [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥10%) are: abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adults Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The rates of adverse reactions in 136 adult patients with SBS participating in two randomized, placebo-controlled, 24-week, double-blind clinical studies (Study 1 and Study 3) are summarized in Table 1 . Only those reactions with a rate of at least 5% in the GATTEX group, and greater than placebo group, are summarized in Table 1 . Table 1: Common Adverse Reactions Reported at a rate of at least 5% in the GATTEX group, and greater than the placebo group.

Lactation : Breastfeeding not recommended. ( 8.2 ) 8.1 Pregnancy Risk Summary Available data from case reports with GATTEX use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant women with short bowel syndrome are at risk for malnutrition, which is associated with adverse maternal and fetal outcomes (see Clinical Considerations ) . In animal reproduction studies, no effects on embryo-fetal development were observed with the subcutaneous administration of teduglutide to pregnant rats and rabbits during organogenesis at exposures up to 686 and 657 times, respectively, the clinical exposure at the recommended human dose (based on AUC) ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with short bowel syndrome are at risk for malnutrition.

Metabolism

Absorption In healthy subjects, GATTEX administered subcutaneously had an absolute bioavailability of 88% and reached maximum plasma teduglutide concentrations at 3 to 5 hours after administration. Following a 0.05 mg/kg subcutaneous dose in SBS subjects, the median peak teduglutide concentration (C max ) was 36 ng/mL and the median area under the curve at steady state (AUC tau ) was 0.15 µg∙hr/mL.

The maximum dose of GATTEX studied during clinical development was 80 mg/day for 8 days. No unexpected systemic adverse reactions were seen. In the event of overdose, the patient should be carefully monitored by the medical professional.

• Dec 21, 2012NDANDA203441Takeda Pharms Usa

1. 1Weight Decreased1,2429.4%
2. 2Vascular Device Infection1,1518.7%
3. 3Nausea1,0828.2%
4. 4Abdominal Pain1,0457.9%
5. 5Product Dose Omission Issue1,0447.9%
6. 6Diarrhoea1,0317.8%
7. 7Dehydration8686.6%
8. 8Weight Increased8606.5%
9. 9Vomiting8346.3%
10. 10Death7715.8%
11. 11Abdominal Distension7085.4%
12. 12Pyrexia6154.7%
13. 13Hospitalisation5914.5%
14. 14Inappropriate Schedule Of Product Administration5374.1%
15. 15Decreased Appetite5183.9%

The 10 most recently updated of 50 ClinicalTrials.gov registrations naming Teduglutide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
  Not yet recruiting · Phase 2 · Interventional · 55 enrolled · International Centre for Diarrhoeal Disease Research, Bangladesh
  NCT07537686updated 2026-04-17
• A Study of Teduglutide in Japanese People With Short Bowel Syndrome
  Active not recruiting · Observational · 250 enrolled · Takeda
  NCT05023382updated 2026-04-13
• A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
  Recruiting · Observational · 12 enrolled · Takeda
  NCT07319832updated 2026-03-13
• TED_ORG: Study on Short Bowel Syndrome
  Recruiting · Interventional · 50 enrolled · Meyer Children's Hospital IRCCS
  NCT07400783updated 2026-02-10
• A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)
  Recruiting · Observational · 600 enrolled · Takeda
  NCT05561647updated 2026-01-26
• Registry for Participants With Short Bowel Syndrome
  Active not recruiting · Observational · 1,806 enrolled · Shire
  NCT01990040updated 2025-10-10
• Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
  Completed · Phase 4 · Interventional · 25 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT03562130updated 2025-09-11
• A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
  Recruiting · Phase 3 · Interventional · 13 enrolled · Takeda
  NCT06973304updated 2025-07-09
• A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada
  Completed · Observational · 52 enrolled · Takeda
  NCT05371028updated 2025-04-06
• Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
  Completed · Phase 3 · Interventional · 61 enrolled · Shire
  NCT02954458updated 2025-03-28

Frequently asked questions

How does Teduglutide work?

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow and inhibit gastric acid secretion.

What is Teduglutide used for?

According to FDA labeling, Teduglutide carries indications including: GATTEX ® 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 . GATTEX ® is a glucagon-like peptide-2 (GLP-2) analog 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Teduglutide?

Teduglutide is classified as Various alimentary tract and metabolism products, GLP-2 Analog, Glucagon-like Peptide-2 (GLP-2) Agonists.

What are the brand names for Teduglutide?

Teduglutide is marketed under brand names including Gattex.

What are the contraindications for Teduglutide?

Teduglutide labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.