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Namespace Prefixes

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Statements

Subject Item
n2:DB00099
rdf:type
n3:Drug
n3:description
Filgrastim is a recombinant, non-pegylated human granulocyte colony stimulating factor (G-CSF) analogue manufactured by recombinant DNA technology using a strain of E. coli. It is marketed as the brand name Neupogen by Amgen. Chemically, it consists of 175 amino acid residues. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E coli. Tbo-filgrastim, which is marketed by Sicor Biotech and FDA approved on August 29, 2012, contains the same active ingredient as Neupogen and is biologically similar, but it is formulated to be short-acting. On March 6, 2015, the FDA approved the biosimilar Zarxio (filgrastim-sndz) and is indicated for use in the same conditions as Neupogen. Zarxio is marketed by Sandoz.
n3:dosage
n4:271B451E-363D-11E5-9242-09173F13E4C5 n4:271B451F-363D-11E5-9242-09173F13E4C5 n4:271B4520-363D-11E5-9242-09173F13E4C5 n4:271B4517-363D-11E5-9242-09173F13E4C5 n4:271B4518-363D-11E5-9242-09173F13E4C5 n4:271B4519-363D-11E5-9242-09173F13E4C5 n4:271B451A-363D-11E5-9242-09173F13E4C5 n4:271B451B-363D-11E5-9242-09173F13E4C5 n4:271B451C-363D-11E5-9242-09173F13E4C5 n4:271B451D-363D-11E5-9242-09173F13E4C5
n3:generalReferences
# Wang B, Ludden TM, Cheung EN, Schwab GG, Roskos LK: Population pharmacokinetic-pharmacodynamic modeling of filgrastim (r-metHuG-CSF) in healthy volunteers. J Pharmacokinet Pharmacodyn. 2001 Aug;28(4):321-42. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/11677930 # FDA label for Neupogen and tbo-filgrastim
n3:group
approved
n3:halfLife
Elimination half-life, healthy subjects and cancer patients, Neopogen = 3.5 hours; Elimination half-life, cancer patients, tbo-filgrastim = 3.2-3.8 hours
n3:indication
Filgrastim is used in patients with acute myeloid leukemia receiving induction or consolidation chemotherapy. It is also used in cancer patients receiving bone marrow transplant. In general, filgrastim increases neutrophil counts in order to decrease the risk of infection or duration of neutropenia in the aforementioned patient populations. Infection and neutropenia are adverse events associated with chemotherapy. Furthermore, filgrastim is also indicated for patients with severe chronic neutropenia. It mobilizes hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis to allow for a more rapid engraftment. Tbo-filgrastim has a narrower indication profile than Neupogen - it is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies.
owl:sameAs
n7:DB00099 n21:DB00099
dcterms:title
Filgrastim
adms:identifier
n11:Filgrastim n12:D03235 n13:55513-209-10 n23:PA449626 n24:P09919 n26:X03438 n27:DB00099
n3:mechanismOfAction
Filgrastim binds to the G-CSF receptor and stimulates the production of neutrophils in the bone marrow. As a G-CSF analog, it controls proliferation of committed progenitor cells and influences their maturation into mature neutrophils. Filgrastim also stimulates the release of neutrophils from bone marrow storage pools and reduces their maturation time. Filgrastim acts to increase the phagocytic activity of mature neutrophils. In patients receiving cytotoxic chemotherapy, Filgrastim can accelerate neutrophil recovery, leading to a reduction in duration of the neutropenic phase
n3:packager
n16:271B4510-363D-11E5-9242-09173F13E4C5 n16:271B4511-363D-11E5-9242-09173F13E4C5
n3:patent
n18:1339071 n18:1341537
n3:routeOfElimination
Filgrastim is primarily eliminated by the kidney and neutrophils/neutrophil precursors; the latter presumably involves binding of the growth factor to the G-CSF receptor on the cell surface, internalization of the growth factor-receptor complexes via endocytosis, and subsequent degradation inside the cells.
n3:synonym
Tbo-filgrastim Granulocyte Colony Stimulating Factor G-CSF
n3:volumeOfDistribution
Vd, healthy subjects and cancer patients = 150 mL/kg
n8:hasAHFSCode
n9:20-16-00
n3:synthesisReference
Tetsuro Kuga, Hiromasa Miyaji, Moriyuki Sato, Masami Okabe, Makoto Morimoto, Seiga Itoh, Motoo Yamasaki, Yoshiharu Yokoo, Kazuo Yamaguchi, Hajime Yoshida, Yoshinori Komatsu, "Method of producing a polypeptide having human granulocyte colony stimulating factor activity." U.S. Patent US5994518, issued February, 1988.
n14:hasConcept
n15:M0028831
foaf:page
n20:filgrastim.htm n28:filgrastim.html
n3:Molecular-Formula
n5:271B4525-363D-11E5-9242-09173F13E4C5
n3:Molecular-Weight
n5:271B4524-363D-11E5-9242-09173F13E4C5
n8:hasATCCode
n22:L03AA02
n3:absorption
Absorption and clearance of Neupogen follows first-order pharmacokinetic modeling without apparent concentration dependence. When 3.45 mcg/kg and 11.5 mcg/kg of Neupogen is subcutaneously administered, the maximum serum concentration is 4 and 49 ng/mL‚ respectively‚ within 2 to 8 hours. Neupogen does not accumulate. It is estimated that when filgrastim is subcutaneously administered, the absolute bioavailability is approximately 62% and 71% for 375 mcg and 750 mcg doses respectively. When 5 mcg/kg tbo-filgrastim is subcutaneously administered, the absolute bioavailability is 33%. It takes 4-6 hours for tho-filgrastim to reach maximum concentration. Like Neupogen, accumulation was not observed.
n3:affectedOrganism
Humans and other mammals
n3:casRegistryNumber
121181-53-1
n3:category
n3:clearance
0.5 - 0.7 mL/minute/kg (SC administration of 3.45 mcg/kg and 11.5 mcg/kg in both normal subjects and cancer patients, Neupogen)
n3:containedIn
n25:271B4512-363D-11E5-9242-09173F13E4C5 n25:271B4513-363D-11E5-9242-09173F13E4C5 n25:271B4516-363D-11E5-9242-09173F13E4C5 n25:271B4514-363D-11E5-9242-09173F13E4C5 n25:271B4515-363D-11E5-9242-09173F13E4C5
n3:Hydrophobicity
n5:271B4522-363D-11E5-9242-09173F13E4C5
n3:Isoelectric-Point
n5:271B4523-363D-11E5-9242-09173F13E4C5
n3:Melting-Point
n5:271B4521-363D-11E5-9242-09173F13E4C5