ty shown for teduglutide in rats, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. [see Nonclinical Toxicology (13.1)]
Pediatric Use
Safety and efficacy in pediatric patients have not been established.
Geriatric Use
No dose adjustment is necessary in patients above the age of 65 years. Of the 566 subjects treated with teduglutide, 43 subjects were 65 years or older, whereas 6 subjects were 75 years of age or older. In the SBS studies, no overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. [see Clinical Pharmacology (12.3)]
Renal Impairment
Reduce the dose of GATTEX by 50% in patients with moderate and severe renal impairment (creatinine clearance less than 50 mL/min) and end-stage renal disease (ESRD). [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]
Hepatic Impairment
GATTEX has not been formally studied in subjects with severe hepatic impairment. No dosage adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects. [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]
Overdosage
The maximum dose of GATTEX studied during clinical development was 80 mg/day for 8 days. In the event of overdose, the patient should be carefully monitored by the medical professional.
Gattex Injection Description
The active ingredient in GATTEX (teduglutide [rDNA origin]) for injection is teduglutide (rDNA origin), which is a 33 amino acid glucagon-like peptide-2 (GLP-2) analog manufactured using a strain of Escherichia coli modified by recombinant DNA technology. The chemical name of teduglutide is L - histidyl - L - glycyl - L - aspartyl - L - glycyl - L - seryl - L - phenylalanyl - L - seryl - L - aspartyl - L - glutamyl - L - methionyl - L - asparaginyl - L - threonyl - L - isoleucyl - L - leucyl - L - aspartyl - L - asparaginyl - L - leucyl - L - alanyl - L - alanyl - L - arginyl - L - aspartyl - L - phenylalanyl - L - isoleucyl - L - asparaginyl - L - tryptophanyl - L - leucyl - L - isoleucyl - L - glutaminyl - L - threonyl - L - lysyl - L - isoleucyl - L - threonyl - L - aspartic acid. The structural formula is:
Figure 1: Structural formula of teduglutide
Teduglutide has a molecular weight of 3752 Daltons. Teduglutide drug substance is a clear, colorless to light-straw–colored liquid.
Each single-use vial of GATTEX contains 5 mg of teduglutide as a white lyophilized powder for solution for subcutaneous injection. In addition to the active pharmaceutical ingredient (teduglutide), each vial of GATTEX contains 3.88 mg L-histidine, 15 mg mannitol, 0.644 mg monobasic sodium phosphate monohydrate, 3.434 mg dibasic sodium phosphate heptahydrate as excipients. No preservatives are present.
At the time of administration the lyophilized powder is reconstituted with 0.5 mL of Sterile Water for Injection, which is provided in a prefilled syringe. A 10 mg/mL sterile solution is obtained after reconstitution. Up to 0.38 mL of the reconstituted solution which contains 3.8 mg of teduglutide can be withdrawn for subcutaneous injection upon reconstitution.
Gattex Injection - Clinical Pharmacology
Mechanism of Action
Teduglutid
