Difference between revisions of "Ropeginterferon alfa-2b (Besremi)"
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==General information== | ==General information== | ||
− | Class/mechanism per [ | + | Class/mechanism per [https://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=753252 NCI Drug Dictionary]: A long-acting formulation of recombinant interferon alpha subtype 2b (IFN-a2b) protein, in which IFN-a2b is coupled, via proline, to polyethylene glycol (PEG), with antiviral, immunomodulating and antineoplastic activities. Upon subcutaneous administration, IFN-a2b binds to specific interferon cell-surface receptors. This activates interferon-mediated signal transduction pathways and induces the transcription and translation of genes with interferon-specific response elements (ISREs); the protein products mediate antiviral, antiproliferative, anticancer, and immune-modulating effects. The PEG moiety inhibits proteolytic breakdown and clearance of IFN-a2b, which prolongs its half-life, extends the duration of its therapeutic effects and allows less frequent dosing. The proline linker facilitates the synthesis of a predominant (90%) positional isomer which allows for further increases in stability and a longer half-life than previous PEG conjugates. |
<br>Route: SC | <br>Route: SC | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
− | == | + | ==Diseases for which it is used== |
+ | *[[Polycythemia vera]] | ||
+ | ==History of changes in FDA indication== | ||
+ | *2021-11-12: Initial approval for adults with [[polycythemia vera]]. ''(Based on PEGINVERA)'' | ||
+ | ==History of changes in EMA indication== | ||
+ | *2019-02-15: Initial authorization | ||
− | === | + | ==History of changes in PMDA indication== |
− | + | *2023-03-27: Initial approval | |
+ | ==Also known as== | ||
+ | *'''Code name:''' AOP-2014 | ||
+ | *'''Generic name:''' ropeginterferon alfa-2b-njft | ||
+ | *'''Brand name:''' Besremi | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Subcutaneous medications]] | [[Category:Subcutaneous medications]] | ||
− | [[Category: | + | [[Category:Pegylated medications]] |
− | [[Category: | + | |
+ | [[Category:Interferon alfas]] | ||
[[Category:Polycythemia vera medications]] | [[Category:Polycythemia vera medications]] | ||
− | [[Category: | + | [[Category:EMA approved in 2019]] |
+ | [[Category:FDA approved in 2021]] | ||
+ | [[Category:PMDA approved in 2023]] |
Latest revision as of 20:19, 27 June 2024
General information
Class/mechanism per NCI Drug Dictionary: A long-acting formulation of recombinant interferon alpha subtype 2b (IFN-a2b) protein, in which IFN-a2b is coupled, via proline, to polyethylene glycol (PEG), with antiviral, immunomodulating and antineoplastic activities. Upon subcutaneous administration, IFN-a2b binds to specific interferon cell-surface receptors. This activates interferon-mediated signal transduction pathways and induces the transcription and translation of genes with interferon-specific response elements (ISREs); the protein products mediate antiviral, antiproliferative, anticancer, and immune-modulating effects. The PEG moiety inhibits proteolytic breakdown and clearance of IFN-a2b, which prolongs its half-life, extends the duration of its therapeutic effects and allows less frequent dosing. The proline linker facilitates the synthesis of a predominant (90%) positional isomer which allows for further increases in stability and a longer half-life than previous PEG conjugates.
Route: SC
Extravasation: n/a
Diseases for which it is used
History of changes in FDA indication
- 2021-11-12: Initial approval for adults with polycythemia vera. (Based on PEGINVERA)
History of changes in EMA indication
- 2019-02-15: Initial authorization
History of changes in PMDA indication
- 2023-03-27: Initial approval
Also known as
- Code name: AOP-2014
- Generic name: ropeginterferon alfa-2b-njft
- Brand name: Besremi