Gattex Generic Name & Formulations
Legal Class
Rx
General Description
Teduglutide 5mg; per vial; lyophilized pwd for SC inj after reconstitution.
Pharmacological Class
Glucagon-like peptide-2 (GLP-2) analogue.
How Supplied
One-vial kit, 30-vial kit—1 (single-use vials w. supplies)
Manufacturer
Generic Availability
NO
Gattex Indications
Indications
Short bowel syndrome (SBS) in patients who are dependent on parenteral support.
Gattex Dosage and Administration
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.
Gattex Contraindications
Not Applicable
Gattex Boxed Warnings
Not Applicable
Gattex Warnings/Precautions
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.
REMS
Gattex Pharmacokinetics
See Literature
Gattex Interactions
Interactions
Monitor concomitant oral drugs requiring titration or with a narrow therapeutic index (eg, benzodiazepines): may require dose adjustment.
Gattex Adverse Reactions
Adverse Reactions
Abdominal pain, nausea, upper respiratory tract infection, abdominal distension, inj site reactions, vomiting, fluid overload, hypersensitivity.
Gattex Clinical Trials
See Literature
Gattex Note
Not Applicable
Gattex Patient Counseling
See Literature