Gattex
teduglutide · KIT · Takeda Pharmaceuticals America, Inc.
Gattex (teduglutide) is an injectable medication belonging to a class of drugs called GLP-2 analogs that is used to treat short bowel syndrome, a condition where the small intestine cannot absorb enough nutrients and fluids from food. It works by helping to increase the absorption capacity of the remaining intestine.
Key Facts
- Brand Name
- Gattex
- Generic Name
- teduglutide
- NDC Code (Product)
68875-0102- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA203441
- Drug Class
- GLP-2 Analog [EPC]
- Marketing Start
- 12/21/2012
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 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 [see Warnings and Precautions ( 5.5 )] . 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.
Adverse Reactions
6 ADVERSE REACTIONS 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 …
Frequently Asked Questions
What is Gattex used for?
Gattex (teduglutide) is an injectable medication belonging to a class of drugs called GLP-2 analogs that is used to treat short bowel syndrome, a condition where the small intestine cannot absorb enough nutrients and fluids from food. It works by helping to increase the absorption capacity of the remaining intestine.
Is Gattex a controlled substance?
Gattex is not classified as a controlled substance by the DEA.
What is the generic name for Gattex?
The generic name for Gattex is teduglutide. There are no other listed brand versions of teduglutide.
What is the NDC code for Gattex ?
The NDC (National Drug Code) for Gattex is 68875-0102, listed by Takeda Pharmaceuticals America, Inc..
Other Gattex Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)