HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX.
GATTEX (teduglutide [rDNA origin]), for injection, for subcutaneous use
Initial U.S. Approval: 2012
INDICATIONS AND USAGE
GATTEX® (teduglutide [rDNA origin]) for injection is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. (1)
DOSAGE AND ADMINISTRATION
The recommended once daily dose of GATTEX is 0.05 mg/kg. (2.1)
Administer by subcutaneous injection; alternate sites between 1 of the 4 quadrants of the abdomen, or into alternating thighs or alternating arms. (2.1)
For subcutaneous injection only. (2.1)
For single-use only. Use within 3 hours after reconstitution, discard any unused portion. (2.5)
50% dosage reduction recommended in patients with moderate to severe renal impairment. (2.3) (8.6) (12.3)
DOSAGE FORMS AND STRENGTHS
For injection: Each single-use glass vial containing 5 mg of teduglutide as a white, lyophilized powder for reconstitution with 0.5 mL Sterile Water for Injection provided in a prefilled syringe. (3)
Reconstitution with the 0.5 mL Sterile Water for Injection provided in the prefilled syringe results in a 10 mg/mL solution. A maximum of 0.38 mL of reconstituted solution which contains 3.8 mg of teduglutide can then be withdrawn from the vial. (3) (16.1)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Neoplastic growth. There is a risk for acceleration of neoplastic growth. Colonoscopy of the entire colon with removal of polyps should be done before initiating treatment with GATTEX and is recommended after 1 year. Subsequent colonoscopies should be done as needed, but no less frequently than every 5 years. In case of intestinal malignancy discontinue GATTEX. The clinical decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on risk and benefit considerations. (5.1)
Intestinal obstruction. In patients who develop obstruction, GATTEX should be temporarily discontinued pending further clinical eva luation and management. (5.2)
Biliary and pancreatic disease. Patients should undergo laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) before starting GATTEX. Subsequent laboratory tests should be done every 6 months. If clinically meaningful changes are seen, further eva luation is recommended including imaging, and continued treatment with GATTEX should be reassessed. (5.3)
Fluid overload. There is a potential for fluid overload while on GATTEX. If fluid overload occurs, especially in patients with cardiovascular disease, parenteral support should be appropriately adjusted, and GATTEX treatment reassessed. (5.4)
ADVERSE REACTIONS
The most common adverse reactions (≥ 10%) across all studies with GATTEX are abdominal pain, injection site reactions, nausea, headaches, abdominal distension, upper respiratory tract infection. In addition, vomiting and fluid overload were reported in the SBS studies (1 and 3) at rates ≥ 10%. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact NPS Pharmaceuticals at 1-855-5GATTEX (1-855-542-8839) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
GATTEX has the potential to increase absorption of concomitant oral medications. Careful monitoring an |
