Adult Dosing

Short Bowel Syndrome

• 0.05 mg/kg SC qday
• The product should be used within 3 hours after reconstitution.

Pediatric Dosing

• Safety and efficacy have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Short Bowel Syndrome (SBS) in patients who are dependent on parenteral support

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Mild impairment: Dose adjsutments not defined
• Moderate-severe impairment (CrCl <50 mL/min) and ESRD: Decrease dose by 50%

Hepatic Dose Adjustment

• Mild-Moderate impairment: No dose adjustments
• Severe impairment: Dose adjustments not defined

• Based on pharmacologic activity and animal findings, has potential to cause hyperplastic changes including neoplasia. Use cautiously in patients at increased risk for malignancy only if the benefits outweigh the risks
• Discontinue therapy in patients with active gastrointestinal malignancy (GI tract, hepatobiliary, pancreatic)
• In patients with active non-gastrointestinal malignancy, the clinical decision to continue therapy should be made based on risk-benefit considerations
• Colorectal polyps have been identified during clinical trials. Colonoscopy of the entire colon with removal of polyps should be done within 6 months prior to starting treatment; follow-up colonoscopy is recommended at the end of 1 yr of teduglutide; if no polyp is found, subsequent colonoscopies should be done no less frequently than every 5 years
• Discontinue therapy on detection of colorectal cancer
• Closely monitor patients for small bowel neoplasia. If a benign neoplasm is found, it should be removed and therapy should be discontinued
• Intestinal obstruction reported; discontinue temporarily and restart when obstruction resolves
• Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported; assess bilirubin, alkaline phosphatase, lipase and amylase within 6 months prior to starting treatment, and then every 6 months
• Fluid overload and congestive heart failure have been observed in clinical trials. If fluid overload occurs, parenteral support should be adjusted and treatment should be reassessed, especially in patients with underlying cardiovascular disease
• Teduglutide has the potential to increase absorption of concomitant oral medications; monitor and adjust dose of oral medications that require titration or have a narrow therapeutic index as necessary; altered mental status has been reported in patients taking benzodiazepines or phenothiazines

Pregnancy Category:B

Breastfeeding: Safety unknown. Because of the potential for possible serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

• CNS: Sleep disturbances, headaches
• GI: Abdominal pain, nausea, abdominal distension, vomiting, fluid overload, flatulence
• RESP: Upper respiratory tract infection, cough
• DERM: Skin hemorrhage
• HYPERSENSITIVITY: hypersensitivity reactions, injection site reactions
• METABOLIC: Appetite disorders

• Glucagon-like peptide-2 (GLP-2) analog; binds to the GLP-2R receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts, and enteric neurons of the submucosal and myenteric plexus and increases intestinal and portal blood flow, and inhibits gastric acid secretion
• Bioavailability: 88%
• Metabolism: Expected to be metabolized into small peptides and amino acids via catabolic pathways
• Excreted primarily in urine
• Half-life: 1.3 hr (SBS); Approximately 2 hours (healthy subjects)

US Trade Name(s)

• Gattex

US Availability

Gattex

• PWDR for INJ: 5 mg vial, 0.5 mL Sterile Water prefilled syringe (reconstituted solution 10 mg/mL); provides 3.8 mg teduglutide/0.38 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Gastrointestinal

Other GI Agents