Drug Detail:Gattex (Teduglutide [ te-due-gloo-tide ])
Generic Name: teduglutide 5mg in 0.5mL
Dosage Form: injection, powder, lyophilized, for solution
Drug Class: Miscellaneous GI agents
Important Administration Information
GATTEX is for adult self-administration or caregiver administration. Self-administration in pediatric patients has not been tested.
Use of the GATTEX 5 mg kit is not recommended in pediatric patients weighing less than 10 kg.
Within 6 months prior to starting treatment with GATTEX:
- Adults: Perform a colonoscopy of the entire colon with removal of polyps [see Warnings and Precautions (5.1)].
- Pediatric patients: Perform fecal occult blood testing; if there is unexplained blood in the stool, perform colonoscopy/sigmoidoscopy [see Warnings and Precautions (5.1)].
- Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase and amylase) [see Warnings and Precautions (5.3)].
Recommended Dosage and Administration for Adults and Pediatric Patients 1 Year of Age and Older
GATTEX is for subcutaneous injection only. Not for intravenous or intramuscular administration.
The recommended dosage of GATTEX is 0.05 mg/kg once daily administered by subcutaneous injection.
If a dose is missed, that dose should be taken as soon as possible on that day. Do not take 2 doses on the same day.
Alternation of sites for subcutaneous injection is recommended, and can include the thighs, upper arms, and the abdomen.
Dosage Adjustment for Renal Impairment
The recommended dosage in adult and pediatric patients with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2) is 0.025 mg/kg once daily [see Use in Specific Populations (8.6)].
Monitoring to Assess Safety
Colonoscopy Schedule in Adults
A follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. If no polyp is found, subsequent colonoscopies should be done no less frequently than every 5 years. If a polyp is found, adherence to current polyp follow-up guidelines is recommended [see Warnings and Precautions (5.1)].
Colonoscopy Schedule in Pediatric Patients
Perform subsequent fecal occult blood testing annually in children and adolescents while they are receiving GATTEX.
Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after 1 year of treatment, every 5 years thereafter while on continuous treatment with GATTEX, and if they have new or unexplained gastrointestinal bleeding [see Warnings and Precautions (5.1)].
Discontinuation of Treatment
Discontinuation of treatment with GATTEX may result in fluid and electrolyte imbalance. Monitor fluid and electrolyte status in patients who discontinue GATTEX treatment [see Warnings and Precautions (5.4)].
Preparation Instructions
- Reconstitute each vial of GATTEX by slowly injecting the 0.5 mL of preservative-free Sterile Water for Injection provided in the prefilled syringe. A 10 mg/mL sterile solution is obtained after reconstitution.
- Allow the vial containing GATTEX and water to stand for approximately 30 seconds and then gently roll the vial between the palms for about 15 seconds. Do not shake the vial.
- Allow the mixed contents to stand for about 2 minutes. Inspect the vial for any undissolved powder. If undissolved powder is observed, gently roll the vial again until all material is dissolved. Do not shake the vial.
- Reconstituted GATTEX is a sterile, clear, colorless to light straw-colored solution, which should be free from particulates. If there is any discoloration or particulates, discard the solution.
- A maximum of 0.38 mL of the reconstituted solution, containing 3.8 mg of teduglutide, can be withdrawn from the vial for dosing.
- If the product remains undissolved after the second attempt, do not use.
