Difference between revisions of "Ropeginterferon alfa-2b (Besremi)"
m |
Warner-admin (talk | contribs) m (Text replacement - "http://www.cancer.gov" to "https://www.cancer.gov") |
||
| (3 intermediate revisions by one other user not shown) | |||
| Line 1: | Line 1: | ||
==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 | ||
| Line 14: | Line 14: | ||
*2023-03-27: Initial approval | *2023-03-27: Initial approval | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' AOP-2014 |
*'''Generic name:''' ropeginterferon alfa-2b-njft | *'''Generic name:''' ropeginterferon alfa-2b-njft | ||
*'''Brand name:''' Besremi | *'''Brand name:''' Besremi | ||
| Line 20: | Line 20: | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Subcutaneous medications]] | [[Category:Subcutaneous medications]] | ||
| + | [[Category:Pegylated medications]] | ||
| − | [[Category: | + | [[Category:Interferon alfas]] |
[[Category:Polycythemia vera medications]] | [[Category:Polycythemia vera medications]] | ||
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