Molecule
Teduglutide is a 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. MedsAcross supplies Teduglutide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
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. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
Source: US FDA prescribing information
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. Evaluation Testing within 6 Months Prior to Starting GATTEX Adult Patients: Perform a colonoscopy and upper GI endoscopy with removal of polyps. Pediatric Patients: Perform fecal occult blood testing. If new or unexplained blood in the stool, perform colonoscopy/sigmoidoscopy and upper GI endoscopy. Adult and Pediatric Patients: Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase and amylase). Dosage and Administration For subcutaneous use only. The recommended dosage of GATTEX for both adults and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
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. 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. 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. Intestinal Obstruction: In patients who develop intestinal or stomal obstruction, temporarily discontinue GATTEX pending further clinical evaluation and management.
Source: US FDA prescribing information
The following serious adverse reactions are described elsewhere in the labeling: Acceleration of Neoplastic Growth Intestinal Obstruction Biliary and Pancreatic Disease Fluid Imbalance and Fluid Overload Most common adverse reactions (≥10%) are: abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.
Source: US FDA prescribing information
Potential for Increased Absorption of Oral Medications Based upon the pharmacodynamic effect of GATTEX, there is a potential for increased absorption of concomitant oral medications. Altered mental status has been observed in patients taking GATTEX and benzodiazepines in the adult clinical studies. Monitor patients on concomitant oral drugs requiring titration or with a narrow therapeutic index for adverse reactions related to the concomitant drug while on GATTEX. The concomitant drug may require a reduction in dosage.
Source: US FDA prescribing information
Store GATTEX 5 mg Strength one-vial kits refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. After Dispensing by the Pharmacist: Store GATTEX 5 mg Strength one-vial kits at room temperature up to 25°C (77°F). Do not freeze. Do not freeze. Store the Carton of Ancillary Supplies at room temperature up to 25°C (77°F). After Dispensing by the Pharmacist: Store GATTEX 5 mg Strength 30-vial kits at room temperature up to 25°C (77°F). Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Teduglutide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Gattex kit Cold chain | Takeda Pharmaceuticals | US FDA | Available on request |
| Gattex 5 mg/0.5 mL powder for injectionSubcutaneous Cold chain | Takeda Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Teduglutide in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Teduglutide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Teduglutide, including Gattex.
Yes. The US FDA first approved Teduglutide on 21 December 2012, according to Drugs@FDA.
Yes. Teduglutide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Teduglutide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Teduglutide is classified under ATC code A16AX08 (Teduglutide).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.