Difference between revisions of "Filgrastim-sndz (Zarxio)"
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==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. | + | 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. The formulation of Filgrastim-sndz (Zarxio) differs from that of [[Filgrastim (Neupogen)]] in one inactive component.<ref name="insert">[http://zarxio.com/assets/pdf/zarxio-pi.pdf Filgrastim-sndz (Zarxio) package insert]</ref><ref>[[Media:Filgrastim-sndz.pdf | Filgrastim-sndz (Zarxio) package insert (locally hosted backup)]]</ref><ref>[http://zarxio.com/ Zarxio manufacturer's website]</ref><ref>[http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436953.htm 3/6/2015 FDA approval announcement for Filgrastim-sndz (Zarxio)]</ref> |
<br>Route: SC | <br>Route: SC | ||
<br>Extravasation: no known issues | <br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information. | + | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | ''Note that colony stimulating factors | + | ''Note that colony stimulating factors may be used for their adjuvant effect e.g. removing leukemia stem cells from their protective niches; but they are not thought to have inherent anti-cancer activity.'' |
==Patient drug information== | ==Patient drug information== | ||
| − | + | *Brief patient counseling information is contained within the [http://zarxio.com/assets/pdf/zarxio-pi.pdf Filgrastim-sndz (Zarxio) package insert]<ref name="insert"></ref> | |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *3/6/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436953.htm FDA Approved as a biosimilar] to US-licensed [[Filgrastim (Neupogen)|Neupogen]] for the five indications for which US-licensed [[Filgrastim (Neupogen)|Neupogen]] is approved. | + | *3/6/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436953.htm FDA Approved as a biosimilar] to US-licensed [[Filgrastim (Neupogen)|Neupogen]] for the five indications for which US-licensed [[Filgrastim (Neupogen)|Neupogen]] is approved: |
| + | **"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" | ||
| + | **"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 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)" | ||
| + | **"Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis" | ||
| + | **"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" | ||
==References== | ==References== | ||
Revision as of 13:13, 7 March 2015
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. The formulation of Filgrastim-sndz (Zarxio) differs from that of Filgrastim (Neupogen) in one inactive component.[1][2][3][4]
Route: SC
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 may be used for their adjuvant effect e.g. removing leukemia stem cells from their protective niches; but they are not thought to have inherent anti-cancer activity.
Patient drug information
- Brief patient counseling information is contained within the Filgrastim-sndz (Zarxio) package insert[1]
History of changes in FDA indication
- 3/6/2015: FDA Approved as a biosimilar to US-licensed Neupogen for the five indications for which US-licensed Neupogen is approved:
- "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"
- "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 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)"
- "Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis"
- "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"