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AboutPricing
Drug ReportsLevoleucovorin calcium
Levoleucovorin calcium
Fusilev, Khapzory, Levoleucovorin (levoleucovorin calcium) is a small molecule pharmaceutical. Levoleucovorin calcium was first approved as Fusilev on 2008-03-07.
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Commercial
Therapeutic Areas
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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
1 products, RLD, RS
Show 1 discontinued
Levoleucovorin calcium
Tradename
Company
Number
Date
Products
FUSILEVAcrotech BiopharmaN-020140 RX2008-03-07
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
No data
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
No data
Clinical
Clinical Trials
606 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——271157918220
Stomach neoplasmsD013274EFO_0003897C16142871247
AdenocarcinomaD000230——720101134
ToxoplasmosisD014123EFO_0007517B581——1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80282310——58
Pancreatic neoplasmsD010190EFO_0003860C2520298—149
Rectal neoplasmsD012004——13188—240
LymphomaD008223—C85.952010—337
Colonic neoplasmsD003110—C18101413—135
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.051615—234
LeukemiaD007938—C9522010—234
Hiv infectionsD015658EFO_0000764B20528—823
Esophageal neoplasmsD004938—C158152—123
Pneumocystis pneumoniaD011020EFO_0007448B592—6—513
Show 34 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509——35———8
Cerebral toxoplasmosisD016781EFO_0007200B58.222——15
Renal cell carcinomaD002292EFO_0000376—33———5
Central nervous system neoplasmsD016543——13——15
Ovarian neoplasmsD010051EFO_0003893C5622———4
Acinar cell carcinomaD018267——22———4
OsteosarcomaD012516——13——14
Myelodysplastic syndromesD009190—D4622———4
Bile duct neoplasmsD001650——12———3
Biphenotypic leukemia acuteD015456—C95.013———3
Show 38 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A3————3
Non-small-cell lung carcinomaD002289——3————3
Lung neoplasmsD008175HP_0100526C34.903————3
Triple negative breast neoplasmsD064726——2————2
Fallopian tube neoplasmsD005185——2————2
Hepatitis cD006526—B19.22————2
GlioblastomaD005909EFO_0000515—2————2
Myeloid leukemia acuteD015470—C92.01————1
Squamous cell carcinoma of head and neckD000077195——1————1
Peritoneal neoplasmsD010534——1————1
Show 12 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Juvenile arthritisD001171EFO_1002007M08————11
ObesityD009765EFO_0001073E66.9————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Appetitive behaviorD001070——————11
Healthy dietD000072001——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLevoleucovorin calcium
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—
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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.[Ca+2]
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1908361
ChEBI ID—
PubChem CID6006
DrugBankDB00650
UNII ID778XL6VBS8 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
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Khapzory – Spectrum Pharmaceuticals
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Fusilev – Spectrum Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 240 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,583 adverse events reported
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