GATTEX KIT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GATTEX KIT (GATTEX KIT).
GATTEX (teduglutide) is a glucagon-like peptide-2 (GLP-2) analog that binds to GLP-2 receptors, promoting intestinal mucosal growth and reducing intestinal permeability. It enhances fluid and nutrient absorption by increasing villus height and crypt depth in the small intestine.
| Metabolism | Teduglutide is metabolized via catabolism to small peptides and amino acids by ubiquitous proteolytic enzymes; not significantly metabolized by CYP450 enzymes. |
| Excretion | Primarily renal excretion of metabolites and unchanged drug; <1% excreted unchanged in feces. |
| Half-life | Terminal elimination half-life is approximately 30 minutes (0.5 hours); short half-life necessitates continuous infusion or frequent dosing. |
| Protein binding | Approximately 98% bound primarily to albumin. |
| Volume of Distribution | Vd ~ 2.8 L/kg, indicating extensive distribution into tissues beyond plasma volume. |
| Bioavailability | Subcutaneous: Approximately 80% bioavailability. |
| Onset of Action | Subcutaneous: Clinical response (reduction in parenteral support volume) may be observed within 1–4 weeks of starting therapy. |
| Duration of Action | Duration of clinical effect is dependent on continued administration; effect wanes within days to weeks after discontinuation. |
0.05 mg/kg subcutaneously once daily
| Dosage form | POWDER |
| Renal impairment | No dosage adjustment required for renal impairment. Not studied in end-stage renal disease. |
| Liver impairment | No dosage adjustment required for mild to moderate hepatic impairment (Child-Pugh class A or B). Not studied in severe hepatic impairment (Child-Pugh class C). |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment recommended; use caution due to greater frequency of renal/hepatic impairment and concomitant disease or drug therapy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GATTEX KIT (GATTEX KIT).
| Breastfeeding | It is not known whether teduglutide is excreted in human milk. In lactating rats, teduglutide was present in milk at concentrations up to 2.3% of maternal plasma levels. Caution should be exercised when administered to a nursing woman. The M/P ratio in humans is unknown. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for GATTEX and any potential adverse effects on the breastfed child from teduglutide or the underlying maternal condition. |
| Teratogenic Risk | There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, teduglutide administered subcutaneously to pregnant rats during organogenesis at doses up to 100 mg/kg/day (approximately 55 times the human AUC at the recommended dose) resulted in embryofetal toxicity (increased postimplantation loss, reduced fetal body weight). In rabbits, doses up to 100 mg/kg/day (approximately 100 times the human AUC) caused maternal toxicity and reduced fetal weights. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. First trimester: limited data; avoid if possible. Second and third trimesters: consider maternal benefit versus fetal risk. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to teduglutide or any component of the formulation","History of gastrointestinal malignancy (active or suspected)"]
| Precautions | ["Risk of neoplastic growth: Avoid use in patients with active gastrointestinal malignancies; monitor for colorectal polyps, especially in patients with risk factors.","Intestinal obstruction: May cause intestinal mucosal hyperplasia; monitor for obstructive symptoms.","Gallbladder and biliary disease: Increased risk of cholecystitis, cholangitis, cholelithiasis; monitor gallbladder function.","Pancreatitis: Cases reported; discontinue if pancreatitis suspected.","Fluid overload: May cause fluid and electrolyte disturbances; adjust parenteral support accordingly."] |
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| Fetal Monitoring | Monitor for signs of fluid overload or electrolyte disturbances, as teduglutide may increase fluid absorption. Monitor for pancreatic enzyme abnormalities (lipase, amylase) due to potential pancreatitis. Monitor for biliary and pancreatic duct changes; consider imaging if symptoms suggestive of biliary obstruction or pancreatitis occur. Monitor for neoplastic changes, as teduglutide may stimulate growth of gastrointestinal epithelium. No specific fetal monitoring is mandated; but standard prenatal monitoring should be performed, including ultrasound to assess fetal growth if maternal fluid status is compromised. |
| Fertility Effects | No fertility studies in humans have been conducted. In animal studies, teduglutide had no adverse effects on male or female fertility in rats at subcutaneous doses up to 50 mg/kg/day (approximately 30 times the human AUC). However, due to the potential for hyperplastic effects, including on reproductive tissues, long-term effects on fertility cannot be excluded. Advise patients of the unknown effects. |