Teduglutide (1 brand name, 1 dosage form, 1 route)
Available dosage forms: POWDER.
Routes of administration: SUBCUTANEOUS.
Brand Names
- GATTEX KIT
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.
Contraindications
None.
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)]
Mechanism of Action
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).
Overdosage
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.