ropeginterferon alfa-2b 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5338 1335098-50-4

Description:

MoleculeDescription

Synonyms:

  • ropeginterferon alfa-2b
  • besremi
  • ropeginterferon alfa-2b-njft
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)
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Feb. 15, 2019 EMA AOP Orphan Pharmaceuticals AG
Nov. 12, 2021 FDA PHARMA ESSENTIA CORPORATION
March 27, 2023 PMDA PharmaEssence Japan K.K

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L03AB15 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSTIMULANTS
IMMUNOSTIMULANTS
Interferons
FDA CS M0023695 Interferon alfa-2b
FDA EPC N0000193982 Interferon alfa-2b

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Interferon alpha/beta receptor Membrane receptor BINDING AGENT DRUG LABEL DRUG LABEL

External reference:

IDSource
981TME683S UNII
C4542175 UMLSCUI
CHEMBL4297819 ChEMBL_ID
86278347 PUBCHEM_CID
DB15119 DRUGBANK_ID
D11027 KEGG_DRUG
9683 INN_ID
018575 NDDF
018889 NDDF
4041000 VANDF
2587059 RXNORM
353801 MMSL
38782 MMSL
40113 MMSL
d09621 MMSL

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BESREMi HUMAN PRESCRIPTION DRUG LABEL 1 73536-500 INJECTION 500 ug SUBCUTANEOUS BLA 34 sections
BESREMi HUMAN PRESCRIPTION DRUG LABEL 1 73536-500 INJECTION 500 ug SUBCUTANEOUS BLA 34 sections