Generic Name and Formulations:
Teduglutide 5mg; per vial; lyophilized pwd for SC inj after reconstitution.
Shire US, Inc.
Indications for GATTEX:
Treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support.
Administer by SC inj only; alternate sites between 1 of the 4 quadrants of the abdomen, or into alternating thighs or arms. 0.05mg/kg once daily. Do not take 2 doses on the same day. Moderate-to-severe renal impairment (CrCl <50mL/min) and ESRD: reduce dose by 50%.
Risk of neoplastic growth acceleration. Discontinue in active GI malignancy (eg, GI tract, hepatobiliary, pancreatic), colorectal or small bowel cancer. Perform colonoscopy with removal of polyps within 6 months before starting; repeat at end of 1yr therapy and every 5yrs or more as needed. Temporarily discontinue if intestinal or stomal obstruction develops; may restart if resolves. Monitor for biliary and pancreatic disease; assess bilirubin, alkaline phosphatase, lipase, amylase within 6 months before starting and at least every 6 months during treatment, or more if needed. Risk of fluid overload; if occurs, adjust parenteral support and reassess treatment (esp. in underlying cardiovascular disease). Reevaluate treatment if significant cardiac deterioration develops. Pregnancy (Cat.B). Nursing mothers: not recommended.
Concomitant oral drugs requiring titration or with a narrow therapeutic index (eg, benzodiazepines, phenothiazines): may require dose adjustment and monitor.
Glucagon-like peptide-2 (GLP-2) analogue.
Abdominal pain, inj site reactions, nausea, headaches, abdominal distension, upper respiratory tract infection, vomiting, fluid overload.
One-vial kit, 30-vial kit—1 (single-use vials w. supplies)