Claim-by-claim evidence
Pharmacokinetics
GATTEX subcutaneous teduglutide: mean terminal half-life is approximately two hours in healthy subjects and 1.3 hours in adults with short bowel syndrome. Pediatric model estimates were about 0.7 hours at ages 1–11 and 1.0 hour at ages 12–17. Renal impairment increases exposure; these are population-specific estimates, not dose-selection rules.
Named U.S. product only; label revision 20250905. Educational extraction, not complete clinical review.
Clinical Pharmacology / 12.3
Contraindications
GATTEX lists no formal contraindications in section 4. This does not remove warnings about neoplastic growth, intestinal obstruction, fluid overload, biliary/pancreatic disease or enhanced absorption of oral medicines.
Named U.S. product only; label revision 20250905. Educational extraction, not complete clinical review.
Contraindications / 4; warnings / 5 where distinguished
Storage
GATTEX 5 mg kits/vials: before dispensing, refrigerate at 2–8°C. After pharmacist dispensing, store up to 25°C with a 90-day use-by date; do not freeze or exceed expiry. Reconstituted solution must be used within three hours and unused solution discarded. These limits are presentation-specific.
Named U.S. product only; label revision 20250905. Educational extraction, not complete clinical review.
How Supplied / Storage and Handling / 16; preparation / 2
Preparation
Use the supplied GATTEX diluent and the exact kit instructions. After reconstitution, use within three hours, then discard any unused portion. This does not authorize a stored multidose research-vial preparation.
Named U.S. product only; label revision 20250905. Educational extraction, not complete clinical review.
Dosage and Administration / 2; interactions / 7
Adverseeffects
GATTEX can increase absorption of oral medicines, including benzodiazepines. Its monitoring requirements address gastrointestinal neoplasia/polyps, obstruction, biliary/pancreatic disease and fluid overload. Review sections 5–7 before use.
Named U.S. product only; label revision 20250905. Educational extraction, not complete clinical review.
Warnings / 5 and Drug Interactions / 7