Gattex Injection Dosage

Generic name: teduglutide 5mg in 0.5mL
Dosage form: injection, powder, lyophilized, for solution
Drug class: Miscellaneous GI agents

Medically reviewed by Drugs.com. Last updated on Sep 27, 2024.

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.

Evaluation and testing prior to starting treatment with GATTEX:

Within 6 months prior to treatment:

Adult patients

Perform a colonoscopy and an upper gastrointestinal (GI) endoscopy with removal of polyps.
Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase and amylase).

Pediatric patients

Perform fecal occult blood testing; if there is new or unexplained blood in the stool, perform colonoscopy/sigmoidoscopy and an upper GI endoscopy.
Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase and amylase).

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.

Monitoring to Assess Safety

Colonoscopy and Upper GI Endoscopy in Adults

A follow-up colonoscopy and upper GI endoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. If no polyp is found, subsequent colonoscopies and upper GI endoscopies (or alternate imaging) should be done no less frequently than every 5 years. If a polyp is found, adherence to current polyp follow-up guidelines is recommended.

Colonoscopy and Upper GI Endoscopy in Pediatric Patients

Perform subsequent fecal occult blood testing annually in pediatric patients while they are receiving GATTEX. If there is new or unexplained blood in the stool, perform colonoscopy/sigmoidoscopy and an upper GI endoscopy.
Colonoscopy/sigmoidoscopy is recommended for all pediatric patients after 1 year of treatment and every 5 years thereafter while on continuous treatment with GATTEX.
Consider upper GI endoscopy (or alternate other imaging) during treatment with GATTEX.

Laboratory Testing

Laboratory assessments are recommended every 6 months. If any clinically meaningful elevation is seen, further diagnostic workup is recommended as clinically indicated (i.e., imaging of the biliary tract, liver, or pancreas).

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.

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.

Storage of the reconstituted solution