Colorectal disorders:

Indications for GATTEX:

Treatment of short bowel syndrome (SBS) in patients who are dependent on parenteral support.

Adults and Children:

<1yr: not established. Administer by SC inj only; alternate sites between 1 of the 4 quadrants of the abdomen, or into alternating thighs or arms. ≥1yr: 0.05mg/kg once daily. Do not take 2 doses on the same day. Moderate-to-severe renal impairment (CrCl <60mL/min) and ESRD: 0.025mg/kg daily.

Warnings/Precautions:

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 in adults; repeat at end of 1yr therapy and every 5yrs or more as needed. Perform fecal occult blood testing before starting in children/adolescents and repeat annually; if unexplained blood in stool, perform colonoscopy/sigmoidoscopy (see full labeling). 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. Monitor fluid and electrolytes when therapy discontinued. Severe hepatic impairment: not studied. Pregnancy. Nursing mothers: not recommended.

Pharmacologic Class:

Glucagon-like peptide-2 (GLP-2) analogue.

Interactions:

Monitor concomitant oral drugs requiring titration or with a narrow therapeutic index (eg, benzodiazepines): may require dose adjustment.

Adverse Reactions:

Abdominal pain, nausea, upper respiratory tract infection, abdominal distension, inj site reactions, vomiting, fluid overload, hypersensitivity.

REMS:

YES

Generic Availability:

NO

How Supplied:

One-vial kit, 30-vial kit—1 (single-use vials w. supplies)