Detailed dose evidence documented for Teduglutide in its monograph — reference only, not dosing recommendations.
Reference only — not a dosing recommendation.
Approved regimen
Approved labeled regimen
Product-, indication-, and jurisdiction-specific — see the monograph
The entries summarize the cited US FDA Gattex label for short bowel syndrome.
Adults: 0.05 mg/kg SC once daily.
Pediatric (≥1 yr): 0.05 mg/kg SC once daily.
Moderate and severe renal impairment and ESRD (eGFR below 60 mL/min/1.73 m²): 0.025 mg/kg SC once daily.
Rotate injection sites (abdomen, thigh, arm).
Adjust dose or discontinue if colonoscopic findings require.
Studied in trials
Studied regimens (not recommendations)
Studied in trials — not a recommended dose
0.10 mg/kg and 0.20 mg/kg studied in Phase 2 but not superior to 0.05 mg/kg.
Twice-weekly GLP-2 analog (apraglutide) is in development for SBS.
Not established
What is not established
Not indicated for Crohn's disease, ulcerative colitis, or other non-SBS intestinal disorders (studied but not approved).
Effect on mortality or long-term survival not established.
Available human pregnancy data are insufficient to evaluate a drug-associated risk; the current label describes animal data rather than an FDA pregnancy letter category.