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Eflapegrastim
Rolvedon (eflapegrastim) is a protein pharmaceutical. Eflapegrastim was first approved as Rolvedon on 2022-09-09.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Rolvedon
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)
Eflapegrastim
Tradename
Proper name
Company
Number
Date
Products
Rolvedoneflapegrastim-xnstSpectrum PharmaceuticalsN-761148 RX2022-09-09
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
rolvedonBiologic Licensing Application2022-09-23
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeutropeniaD009503D70112——4
Breast neoplasmsD001943EFO_0003869C502—2——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80—1———1
LymphomaD008223C85.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
PharmacokineticsD0105991————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEFLAPEGRASTIM
INNeflapegrastim
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.
Classification
Protein
Drug classFc 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-ID1384099-30-2
RxCUI—
ChEMBL IDCHEMBL3833384
ChEBI ID—
PubChem CID—
DrugBankDB15001
UNII IDUT99UG9QJX (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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