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Gattex
Overview
What is Gattex?
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 modified by recombinant DNA technology. The chemical composition 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:
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 Up to 0.38 mL of the reconstituted solution which contains 3.8 mg of teduglutide can be withdrawn for subcutaneous injection upon reconstitution.
What does Gattex look like?
What are the available doses of Gattex?
For Injection: Each single-use glass vial contains a dose of 5 mg teduglutide as a lyophilized powder that upon reconstitution with the 0.5 mL Sterile Water for Injection provided in the prefilled syringe delivers a maximum of 0.38 mL of the reconstituted sterile solution which contains 3.8 mg of teduglutide.
What should I talk to my health care provider before I take Gattex?
The safety and efficacy of GATTEX in pediatric patients have not been established. ()
How should I use Gattex?
GATTEX (teduglutide [rDNA origin]) for injection is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support
The recommended daily dose of GATTEX is 0.05 mg/kg body weight administered by subcutaneous injection once daily. Alternation of sites for subcutaneous injection is recommended, and can include the thighs, arms, and the quadrants of the abdomen. GATTEX should be administered intravenously or intramuscularly. 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.
What interacts with Gattex?
Sorry No Records found
What are the warnings of Gattex?
Sorry No Records found
What are the precautions of Gattex?
Sorry No Records found
What are the side effects of Gattex?
Sorry No records found
What should I look out for while using Gattex?
None.
What might happen if I take too much Gattex?
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.
How should I store and handle Gattex?
Prior to Dispensing: Store refrigerated at 2°C to 8°C (36°F to 46°F) for and the . Do not freeze. Do not use beyond the expiration date on the label. Store at room temperature up to 25°C (77°F) for the .Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].Citalopram tablets, USP 10 mg are Peach colored, round, biconvex, film coated tablets with “c” debossed on one side and plain on the other side available as follows:Bottle of 100 NDC 57664-507-88Bottle of 500 NDC 57664-507-13Citalopram tablets, USP 20 mg are Pink colored, oval, biconvex, film coated tablets with “508” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-508-88Bottle of 500 NDC 57664-508-13Bottle of 1000 NDC 57664-508-18Citalopram tablets, USP 40 mg are White colored, oval, biconvex, film coated tablets with “509” debossed on one side and scored on the other side available as follows:Bottle of 100 NDC 57664-509-88Bottle of 500 NDC 57664-509-13Bottle of 1000 NDC 57664-509-18Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
Non-Clinical Toxicology
None.Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible pediatric patients.
Preliminary animal and human studies have shown that small quantities of systemically administered leucovorin enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered methotrexate.
Leucovorin may enhance the toxicity of 5-fluorouracil (see ).
Based on the pharmacologic activity and findings in animals, GATTEX has the potential to cause hyperplastic changes including neoplasia. In patients at increased risk for malignancy, the clinical decision to use GATTEX should be considered only if the benefits outweigh the risks. In patients with active gastrointestinal malignancy (GI tract, hepatobiliary, pancreatic), GATTEX therapy should be discontinued. In patients with active non-gastrointestinal malignancy, the clinical decision to continue GATTEX should be made based on risk-benefit considerations .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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