Eflapegrastim
Rolvedon (eflapegrastim) is a protein pharmaceutical. Eflapegrastim was first approved as Rolvedon on 2022-09-09.
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Commercial
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Rolvedon
Drug Products
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Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Eflapegrastim
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Rolvedon | eflapegrastim-xnst | Spectrum Pharmaceuticals | N-761148 RX | 2022-09-09 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rolvedon | Biologic Licensing Application | 2023-11-08 |
Indications
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Agency Specific
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Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | D009503 | — | D70 | 1 | 1 | 2 | 1 | — | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | 2 | 1 | — | 5 |
Indications Phases 3
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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 | — | — | — | 2 | — | — | — | — | 2 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Eflapegrastim |
| INN | eflapegrastim |
| Description | Eflapegrastim, sold under the brand names Rolvedon among others, is a long-acting G-CSF analog developed by Hanmi Pharmaceutical and licensed to Spectrum Pharmaceuticals. Eflapegrastim is a leukocyte growth factor. It is used to reduce the risk of febrile neutropenia in people with non-myeloid malignancies receiving myelosuppressive anti-cancer agents.
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| Classification | Protein |
| Drug class | Fc fusion protein; colony-stimulating factors: granulocyte colony-stimulating factors (G-CSF); PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3833384 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | UT99UG9QJX (ChemIDplus, GSRS) |
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Rolvedon – Assertio Therapeutics
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Trends
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Additional graphs summarizing 30 documents
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Safety
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14 adverse events reported
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