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Namespace Prefixes

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Statements

Subject Item
n2:DB08900
rdf:type
n3:Drug
n3:description
Teduglutide is a glucagon-like peptide-2 (GLP-2) analogue. It is made up of 33 amino acids and is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. Teduglutide differs from GLP-2 by one amino acid (alanine is substituted by glycine). The significance of this substitution is that teduglutide is longer acting than endogenous GLP-2 as it is more resistant to proteolysis from dipeptidyl peptidase-4. FDA approved on December 21, 2012.
n3:dosage
n21:271B5B98-363D-11E5-9242-09173F13E4C5 n21:271B5B99-363D-11E5-9242-09173F13E4C5
n3:generalReferences
# Burness CB, McCormack PL: Teduglutide: A Review of its Use in the Treatment of Patients with Short Bowel Syndrome. Drugs. 2013 Jun 1. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/23729002 # Semrad CE: The Long Road to a New Short-Bowel Therapy: Teduglutide for Clinical Use. Clin Gastroenterol Hepatol. 2013 Apr 13. pii: S1542-3565(13)00471-0. doi: 10.1016/j.cgh.2013.03.030. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/23591284 # Jeppesen PB: Teduglutide, a novel glucagon-like peptide 2 analog, in the treatment of patients with short bowel syndrome. Therap Adv Gastroenterol. 2012 May;5(3):159-71. doi: 10.1177/1756283X11436318. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/22570676
n3:group
approved
n3:halfLife
Terminal half-life, healthy subjects = 2 hours; Terminal half-life, SBS patients = 1.3 hours
n3:indication
Treatment of short bowel syndrome (SBS), malabsorption associated with the removal of the intestine, in adults patients who are dependent on parenteral support.
owl:sameAs
n14:DB08900
dcterms:title
Teduglutide
adms:identifier
n9:68875-0101-2 n10:Teduglutide n11:C16049 n12:D06053 n15:72305 n17:DB08900
n3:mechanismOfAction
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine in response to meals. GLP-2 increases intestinal and portal blood flow and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. This causes the release of insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). These growth factors may contribute to the increase in crypt cell growth and surface area of the gastric mucosa. Ultimately, absorption through the intestine is enhanced.
n3:patent
n5:7056886 n5:7847061 n5:5789379
n3:routeOfElimination
Urine
n3:synonym
His-gly-asp-gly-ser-phe-ser-asp-glu-met-asn-thr-ile-leu-asp-asn-leu-ala-ala-arg-asp-phe-ile-asn-trp-leu-ile-gln-thr-lys-ile-thr-asp Teduglutide Recombinant Glucagon-like peptide ii (2-glycine) (human) Teduglutide [rDNA origin] (Gly2)glp-2 HGDGSFSDEMNTILDNLAARDFINWLIQTKITD Gly(2)-glp-2 Gattex ALX 0600 ALX-0600
n3:toxicity
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%.
n3:volumeOfDistribution
Vd, healthy subjects = 103 mL/kg
n6:hasAHFSCode
n16:56-92
foaf:page
n19:gattex-drug.htm n22:teduglutide.html
n3:Molecular-Formula
n20:271B5B9B-363D-11E5-9242-09173F13E4C5
n3:Molecular-Weight
n20:271B5B9A-363D-11E5-9242-09173F13E4C5
n6:hasATCCode
n7:A16AX08
n3:absorption
The pharmacokinetic profile of teduglutide (when administered subcutaneously) is described by a one-compartment model with first order absorption in the abdomen, arm, and thigh. With escalating doses, teduglutide demonstrates linear pharmacokinetics. Absolute bioavailability, SubQ = 88%; Tmax, SubQ = 3-5 hours; Cmax, 0.05 mg/kg SubQ, SBS patients = 36 ng/mL; AUC, 0.05 mg/kg SubQ, SBS patients = 0.15 µg•hr/mL; Teduglutide does not accumulate following multiple subcutaneous administrations.
n3:affectedOrganism
Humans and other mammals
n3:casRegistryNumber
197922-42-2
n3:clearance
Plasma clearance, healthy subjects = 123 mL/hr/kg; This value indicates that teduglutide is primarily cleared by the kidney.