Difference between revisions of "Filgrastim (Neupogen)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m (Text replacement - "[[Category:Drugs FDA" to "[[Category:FDA")
m (Text replacement - "chemocare.com/chemotherapy/drug-info" to "chemocare.com/druginfo")
(11 intermediate revisions by 3 users not shown)
Line 1: Line 1:
 
==General information==
 
==General information==
−
Class/mechanism: Recombinant human granulocyte colony-stimulating factor (G-CSF). Binds to cell surface receptors on hematopoietic cells and stimulates proliferation‚ differentiation, and some end-cell functional activation.<ref name="insert">[http://pi.amgen.com/united_states/neupogen/neupogen_pi_hcp_english.pdf Filgrastim (Neupogen) package insert]</ref><ref>[[Media:Filgrastim.pdf | Filgrastim (Neupogen) package insert (locally hosted backup)]]</ref><ref>[http://www.neupogen.com/ Neupogen manufacturer's website]</ref>
+
Class/mechanism: Recombinant human granulocyte colony-stimulating factor (G-CSF). Binds to cell surface receptors on hematopoietic cells and stimulates proliferation, differentiation, and some end-cell functional activation.<ref name="insert">[http://pi.amgen.com/united_states/neupogen/neupogen_pi_hcp_english.pdf Filgrastim (Neupogen) package insert]</ref><ref>[[:File:Filgrastim.pdf | Filgrastim (Neupogen) package insert (locally hosted backup)]]</ref><ref>[http://www.neupogen.com/ Neupogen manufacturer's website]</ref>
 
<br>Route: SC, IV
 
<br>Route: SC, IV
 
<br>Extravasation: no known issues
 
<br>Extravasation: no known issues
Line 10: Line 10:
  
 
*[[Acute myeloid leukemia]]
 
*[[Acute myeloid leukemia]]
 +
*[[B-cell acute lymphoblastic leukemia]]
 +
*[[Neuroblastoma]]
  
 
==Patient drug information==
 
==Patient drug information==
 
*[http://pi.amgen.com/united_states/neupogen/neupogen_pi_hcp_english.pdf Filgrastim (Neupogen) package insert]<ref name="insert"></ref>
 
*[http://pi.amgen.com/united_states/neupogen/neupogen_pi_hcp_english.pdf Filgrastim (Neupogen) package insert]<ref name="insert"></ref>
−
*[http://chemocare.com/chemotherapy/drug-info/filgrastim.aspx Filgrastim (Neupogen) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/filgrastim.aspx Filgrastim (Neupogen) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/filgrastim.aspx Filgrastim (Neupogen) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/filgrastim.aspx Filgrastim (Neupogen) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/filgrastim-patient-drug-information Filgrastim (Neupogen) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/filgrastim-patient-drug-information Filgrastim (Neupogen) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/filgrastim-patient-drug-information Filgrastim (Neupogen) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/filgrastim-patient-drug-information Filgrastim (Neupogen) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*2/20/1991: Initial FDA approval.
+
*1991-02-20: Initial approval.
−
*Currently approved to:
+
*Uncertain date: Approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.
−
**"Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever"
+
*Uncertain date: Approved to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
−
**"Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)"
+
*Uncertain date: Approved to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
−
**"Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)"
+
*Uncertain date: Approved to mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
−
**"Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis"
+
*Uncertain date: Approved to reduce the incidence and duration of sequelae of severe neutropenia (e.g.,fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
−
**"Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia"
+
==History of changes in PMDA indication==
 +
*2021-06-23: New indication and a new dosage for the enhancement of an antitumor effect of dinutuximab (genetical recombination) for [[neuroblastoma]].
 +
*2022-06-20: New indication and a new dosage for use as an adjunctive therapy with antineoplastic agents for the treatment of relapsed or refractory [[acute myeloid leukemia]].
  
 
==Also known as==
 
==Also known as==
−
{| border="1" style="text-align:center;"
+
*'''Generic names:''' filgrastim, GCSF, G-CSF, granulocyte colony stimulating factor
 +
*'''Brand names:'''
 +
{| class="wikitable" style="text-align:center;"
 
!colspan="8" align="center" style="background-color:#0066FF"| '''Synonyms'''
 
!colspan="8" align="center" style="background-color:#0066FF"| '''Synonyms'''
 
|-
 
|-
−
|BAO LI JIN
 
 
|Biocilin
 
|Biocilin
 
|Biofigran
 
|Biofigran
Line 36: Line 41:
 
|Filatil
 
|Filatil
 
|Filgen
 
|Filgen
−
|Filgrastim
 
−
|-
 
 
|Filgrastima
 
|Filgrastima
−
|GCSF
 
−
|G-CSF
 
 
|Gran
 
|Gran
−
|Gran Kirin
+
|-
−
|Gran Sankyo
 
−
|Granulocyte Colony Stimulating Factor
 
 
|Granulokine
 
|Granulokine
−
|-
 
 
|Grasalva
 
|Grasalva
 
|Grasin
 
|Grasin
Line 54: Line 52:
 
|Leucin
 
|Leucin
 
|Leucocim
 
|Leucocim
 +
|-
 
|Leucokain
 
|Leucokain
−
|-
 
 
|Leucostim
 
|Leucostim
 
|Leukokine
 
|Leukokine
 
|Leumostin
 
|Leumostin
 
|Lioplim
 
|Lioplim
−
|LI Sheng SU
 
 
|Mielastra
 
|Mielastra
 
|Myelostim
 
|Myelostim
Line 68: Line 65:
 
|Neukine
 
|Neukine
 
|Neupogen
 
|Neupogen
−
|Neupogen Amgen 48
 
−
|Neupogen Novum
 
−
|Neupogen Singleject
 
 
|Nevkine
 
|Nevkine
−
|Nivestim
+
|Topneuter
 +
|
 +
|
 +
|
 
|-
 
|-
−
|RUI BAI
 
−
|TE ER JIN
 
−
|Topneuter
 
−
|XIN LI Sheng
 
 
|}
 
|}
  
Line 89: Line 82:
  
 
[[Category:Acute myeloid leukemia medications]]
 
[[Category:Acute myeloid leukemia medications]]
 +
[[Category:B-cell acute lymphoblastic leukemia medications]]
 +
[[Category:Neuroblastoma medications]]
  
 
[[Category:FDA approved in 1991]]
 
[[Category:FDA approved in 1991]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Revision as of 23:30, 2 September 2023

General information

Class/mechanism: Recombinant human granulocyte colony-stimulating factor (G-CSF). Binds to cell surface receptors on hematopoietic cells and stimulates proliferation, differentiation, and some end-cell functional activation.[1][2][3]
Route: SC, IV
Extravasation: no known issues

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Note that colony stimulating factors are used for their adjuvant effect e.g. removing leukemia stem cells from their protective niches; they are not thought to have inherent anti-cancer activity.

Patient drug information

History of changes in FDA indication

  • 1991-02-20: Initial approval.
  • Uncertain date: Approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.
  • Uncertain date: Approved to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
  • Uncertain date: Approved to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
  • Uncertain date: Approved to mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
  • Uncertain date: Approved to reduce the incidence and duration of sequelae of severe neutropenia (e.g.,fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.

History of changes in PMDA indication

  • 2021-06-23: New indication and a new dosage for the enhancement of an antitumor effect of dinutuximab (genetical recombination) for neuroblastoma.
  • 2022-06-20: New indication and a new dosage for use as an adjunctive therapy with antineoplastic agents for the treatment of relapsed or refractory acute myeloid leukemia.

Also known as

  • Generic names: filgrastim, GCSF, G-CSF, granulocyte colony stimulating factor
  • Brand names:
Synonyms
Biocilin Biofigran Biofilgran Euprotin Filatil Filgen Filgrastima Gran
Granulokine Grasalva Grasin Grastim Leicita Leubene Leucin Leucocim
Leucokain Leucostim Leukokine Leumostin Lioplim Mielastra Myelostim Neipogen
Neitrostim Neukine Neupogen Nevkine Topneuter

References

  1. ↑ 1.0 1.1 1.2 Filgrastim (Neupogen) package insert
  2. ↑ Filgrastim (Neupogen) package insert (locally hosted backup)
  3. ↑ Neupogen manufacturer's website
  4. ↑ Filgrastim (Neupogen) patient drug information (Chemocare)
  5. ↑ Filgrastim (Neupogen) patient drug information (UpToDate)
Retrieved from "https://hemonc.org/w/index.php?title=Filgrastim_(Neupogen)&oldid=77138"