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Levoleucovorin
Fusilev, Khapzory (levoleucovorin) is a small molecule pharmaceutical. Levoleucovorin was first approved as Fusilev on 2008-03-07.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Fusilev, Khapzory (generic drugs available since 2015-03-09)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levoleucovorin
Tradename
Company
Number
Date
Products
KHAPZORYAcrotech BiopharmaN-211226 RX2018-10-19
2 products, RLD, RS
Levoleucovorin calcium
Tradename
Company
Number
Date
Products
FUSILEVAcrotech BiopharmaN-020140 RX2008-03-07
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
fusilevNew Drug Application2020-11-24
khapzoryNew Drug Application2023-06-02
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Levoleucovorin, Khapzory, Acrotech Biopharma
115410122039-03-25DP
ATC Codes
V: Various drug classes in atc
V03: All other therapeutic products
V03A: All other therapeutic products
V03AF: Detoxifying agents for antineoplastic treatment
V03AF04: Calcium levofolinate
HCPCS
Code
Description
J0641
Injection, levoleucovorin, not otherwise specified, 0.5 mg
J0642
Injection, levoleucovorin (khapzory), 0.5 mg
Clinical
Clinical Trials
152 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic rhinitis seasonalD006255EFO_0003956J306411526
Allergic rhinitisD065631J30.93611222
Healthy volunteers/patients1211216
Allergic rhinitis perennialD012221EFO_1001417J30.897815
RhinitisD012220EFO_0008521J313132211
HypersensitivityD006967EFO_0003785T78.40639
UrticariaD014581EFO_0005531L503418
Chronic urticariaD000080223L50.8358
AsthmaD001249EFO_0000270J451336
PruritusD011537HP_0000989L291315
Show 10 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic conjunctivitisD003233EFO_0007141H10.44155
DermatitisD003872HP_0011123L30.9112
Vasomotor rhinitisD012223EFO_0007533J30.0112
Breast neoplasmsD001943EFO_0003869C5011
Ovarian neoplasmsD010051EFO_0003893C5611
Endometrial neoplasmsD016889EFO_000423011
Head and neck neoplasmsD00625811
Esophageal neoplasmsD004938C1511
Lung neoplasmsD008175C34.9011
Uterine cervical neoplasmsD00258311
Show 2 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD01517911
Neuromyelitis opticaD009471EFO_0004256G36.0111
CoughD003371HP_0012735R0511
Diabetic nephropathiesD003928EFO_000040111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ProstatitisD011472EFO_0003830N4111
Migraine disordersD008881EFO_0003821G4311
FastingD005215EFO_000275611
Larva migransD007815EFO_0007391B76.911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CognitionD003071EFO_000392511
Actinic keratosisD055623L57.011
SinusitisD012852EFO_0007486J3211
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLEVOLEUCOVORIN
INNcalcium levofolinate
Description
Folinic acid, also known as leucovorin, is a medication used to decrease the toxic effects of methotrexate and pyrimethamine. It is also used in combination with 5-fluorouracil to treat colorectal cancer and pancreatic cancer, may be used to treat folate deficiency that results in anemia, and methanol poisoning. It is taken by mouth, injection into a muscle, or injection into a vein.
Classification
Small molecule
Drug class
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Nc1nc(=O)c2c([nH]1)NC[C@H](CNc1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1)N2C=O
Identifiers
PDB
CAS-ID68538-85-2
RxCUI
ChEMBL IDCHEMBL1908841
ChEBI ID63606
PubChem CID6006
DrugBankDB00650
UNII ID778XL6VBS8 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Fusilev - Spectrum Pharmaceuticals
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 142 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,319 adverse events reported
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