Pegintron(peginterferon alfa-2b)
PegIntron, PegIntron/ Rebetol Combo Pack, Sylatron, ViraferonPeg (peginterferon alfa-2b) is a protein pharmaceutical. Peginterferon alfa-2b was first approved as Pegintron on 2000-05-24. It is used to treat brain neoplasms, chronic hepatitis c, colorectal neoplasms, cryoglobulinemia, and essential thrombocythemia amongst others in the USA. It has been approved in Europe to treat chronic hepatitis c. The pharmaceutical is active against interferon alpha/beta receptor 1.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| neoplasms | D009369 |
| digestive system diseases | D004066 |
| nervous system diseases | D009422 |
| eye diseases | D005128 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| hemic and lymphatic diseases | D006425 |
| skin and connective tissue diseases | D017437 |
| immune system diseases | D007154 |
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Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Peginterferon alfa-2b
Peginterferon alfa-2b
+
Ribavirin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | Merck Sharp & Dohme | N-125196 DISCN | 2008-06-13 | 4 products |
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| brain neoplasms | EFO_0003833 | D001932 | C71 |
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
| colorectal neoplasms | — | D015179 | — |
| cryoglobulinemia | EFO_0005846 | D003449 | D89.1 |
| essential thrombocythemia | — | D013920 | D47.3 |
| hairy cell leukemia | — | D007943 | C91.4 |
| hemangioma | — | D006391 | D18.0 |
| hepatitis d | EFO_0007304 | D003699 | — |
| hepatocellular carcinoma | — | D006528 | C22.0 |
| hypereosinophilic syndrome | EFO_1001467 | D017681 | D72.11 |
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
333 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 3 | 28 | 53 | 27 | 37 | 141 |
| Hepatitis c | D006526 | B19.2 | 4 | 15 | 25 | 11 | 20 | 68 | |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 1 | 6 | 13 | 8 | 5 | 32 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 5 | 12 | 6 | 3 | 2 | 24 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 9 | 1 | 3 | 13 |
| Hepacivirus | D016174 | — | 3 | 3 | 2 | 6 | 12 | ||
| Neoplasms | D009369 | C80 | 4 | 1 | — | 1 | — | 6 | |
| Hepatitis b | D006509 | — | 1 | 1 | 1 | 3 | 6 | ||
| Fibrosis | D005355 | — | 1 | 1 | 1 | 1 | 4 | ||
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | 1 | 3 | 1 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | 8 | 9 | 4 | — | — | 18 | ||
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | 6 | 5 | — | — | 10 | |
| Polycythemia vera | D011087 | D45 | — | 1 | 4 | — | — | 5 | |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | — | — | 3 | |
| Chronic hepatitis | D006521 | K73.9 | 1 | 2 | 1 | — | — | 3 | |
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | 1 | — | — | 2 | |
| Renal cell carcinoma | D002292 | 1 | 2 | 1 | — | — | 2 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | 1 | 2 |
| Coinfection | D060085 | — | — | 2 | — | — | 2 | ||
| Osteosarcoma | D012516 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 3 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 1 | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | 2 | 1 | — | — | — | 2 | ||
| Squamous cell carcinoma | D002294 | — | 1 | — | — | — | 1 | ||
| Squamous cell neoplasms | D018307 | — | 1 | — | — | — | 1 | ||
| Neurofibromatosis 1 | D009456 | Q85.01 | — | 1 | — | — | — | 1 | |
| Myeloid leukemia chronic-phase | D015466 | — | 1 | — | — | — | 1 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | 1 | — | — | — | 1 |
| Leukemia | D007938 | C95 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intravenous substance abuse | D015819 | — | — | — | — | 1 | 1 | ||
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 1 | 1 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | — | — | — | — | 1 | 1 | |
| Ascites | D001201 | HP_0001541 | R18 | — | — | — | — | 1 | 1 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PEGINTERFERON ALFA-2B |
| INN | peginterferon alfa-2b |
| Description | Interferon alpha-2 precursor (Interferon alpha-A) (LeIF A) |
| Classification | Protein |
| Drug class | PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 215647-85-1 |
| RxCUI | 253453 |
| ChEMBL ID | CHEMBL1201561 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00022 |
| UNII ID | G8RGG88B68 (ChemIDplus, GSRS) |
Target
Agency Approved
IFNAR1
IFNAR1
Organism
Homo sapiens
Gene name
IFNAR1
Gene synonyms
IFNAR
NCBI Gene ID
Protein name
interferon alpha/beta receptor 1
Protein synonyms
alpha-type antiviral protein, beta-type antiviral protein, CRF2-1, Cytokine receptor class-II member 1, Cytokine receptor family 2 member 1, IFN-alpha/beta receptor 1, IFN-R-1, IFNalpha/beta receptor 1, interferon (alpha, beta and omega) receptor 1, interferon receptor 1, interferon-alpha/beta receptor alpha chain, interferon-beta receptor 1, Type I interferon receptor 1
Uniprot ID
Mouse ortholog
Ifnar1 (15975)
interferon alpha/beta receptor 1 (Q80UJ3)
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000225949 | IFNL4, 151-152G>A | drug response | 2021-03-24 | 1A |
| VCV000226027 | IFNL3 | drug response | 2021-03-29 | 1B |
| VCV000375658 | IFNL3, 259-126T>C | drug response | 2021-03-24 | 2A |
| VCV000014747 | ITPA, 124+21A>C | drug response | 2021-03-24 | 2B |
| VCV000014746 | ITPA, 94C>A, Pro32Thr | drug response | 2021-03-24 | 2B |
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 490 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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51,186 adverse events reported
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