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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5338 | 1335098-50-4 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Ropeginterferon alfa-2b is a recombinant interferon alfa-2b conjugated with a two-arm methoxypolyethylene glycol (mPEG). It belongs to the class of type I interferons which exhibit their cellular effects by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR). Binding to IFNAR initiates a downstream signalling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins. Nuclear translocation of STAT proteins controls distinct gene-expression programs and exhibit various cellular effects. Interferon alfa was shown to have an inhibitory effect on the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonised the action of growth factors and other cytokines that have a role in the development of myelofibrosis. These actions may be involved in the therapeutic effects of interferon alfa in polycythaemia vera.Further, it was demonstrated that interferon alfa is able to decrease the mutated JAK2V617F allele burden in patients with polycythaemia vera (a V617F point mutation in the JAK2 kinase is a hallmark of polycythaemia vera and is present in approximately 95% of patients)
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 15, 2019 | EMA | AOP Orphan Pharmaceuticals AG | |
| Nov. 12, 2021 | FDA | PHARMA ESSENTIA CORPORATION | |
| March 27, 2023 | PMDA | PharmaEssence Japan K.K |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Fatigue | 46.45 | 42.70 | 44 | 488 | 1153979 | 89473936 |
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| Source | Code | Description |
|---|---|---|
| ATC | L03AB15 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSTIMULANTS IMMUNOSTIMULANTS Interferons |
| FDA CS | M0023695 | Interferon alfa-2b |
| FDA EPC | N0000193982 | Interferon alfa-2b |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:64951 | anti-HBV agent |
| CHEBI has role | CHEBI:233423 | antifibrotic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Polycythemia vera | indication | 109992005 | |
| Suicidal ideation | contraindication | 6471006 | |
| Immunosuppressed transplant recipients | contraindication | 7447008 | |
| Suicide attempt | contraindication | 82313006 | |
| Autoimmune disease | contraindication | 85828009 | |
| Severe depression | contraindication | 310497006 | |
| Moderate hepatic impairment | contraindication | 710066005 | |
| Severe hepatic impairment | contraindication | 710067001 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interferon alpha/beta receptor | Membrane receptor | BINDING AGENT | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 981TME683S | UNII |
| 4041000 | VANDF |
| C4542175 | UMLSCUI |
| CHEBI:757263 | CHEBI |
| CHEMBL4297819 | ChEMBL_ID |
| 86278347 | PUBCHEM_CID |
| DB15119 | DRUGBANK_ID |
| D11027 | KEGG_DRUG |
| 9683 | INN_ID |
| C000731926 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1286820000 | SNOMEDCT_US |
| 353801 | MMSL |
| 38782 | MMSL |
| 40113 | MMSL |
| d09621 | MMSL |
| 018575 | NDDF |
| 018889 | NDDF |
| 2587059 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| BESREMi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73536-500 | INJECTION | 500 ug | SUBCUTANEOUS | BLA | 34 sections |