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Drug ReportsLevoleucovorin calcium
Levoleucovorin calcium
Khapzory, Levoleucovorin (levoleucovorin calcium) is a small molecule pharmaceutical. Levoleucovorin calcium was first approved as Fusilev on 2008-03-07.
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Abbreviated New Drug Application (ANDA)
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khapzoryNew Drug Application2024-12-12
levoleucovorinANDA2023-08-01
levoleucovorin calciumANDA2023-08-29
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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
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Clinical
Clinical Trials
1274 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——80268146520477
AdenocarcinomaD000230——431074018180
Pancreatic neoplasmsD010190EFO_0003860C2551953117162
NeoplasmsD009369—C8071662313145
Stomach neoplasmsD013274EFO_0003897C1623651917104
Esophageal neoplasmsD004938—C151848101370
Neoplasm metastasisD009362EFO_0009708—1237201466
Liver neoplasmsD008113EFO_1001513C22.0725131545
CholangiocarcinomaD018281—C22.151321—20
Non-small-cell lung carcinomaD002289——124—2—15
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rectal neoplasmsD012004——215425—599
Colonic neoplasmsD003110—C18173438—786
CarcinomaD002277—C80.0234323—685
LeukemiaD007938—C95164229—483
LymphomaD008223—C85.9144219—674
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.0103128—365
Lymphoid leukemiaD007945—C91102825—359
RecurrenceD012008——15237—143
Pancreatic ductal carcinomaD021441——13175—132
Hepatocellular carcinomaD006528—C22.03208—331
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Indications Phases 2
Indication
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Ontology
ICD-10
Ph 1
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Myelodysplastic syndromesD009190—D4683———10
PreleukemiaD011289——83———10
Ovarian neoplasmsD010051EFO_0003893C5646———10
SarcomaD012509——36———9
OsteosarcomaD012516——45——19
Breast neoplasmsD001943EFO_0003869C5044———8
Digestive system neoplasmsD004067——64———8
ArthritisD001168EFO_0005856M05-M1426——18
Myeloid leukemia acuteD015470—C92.071———7
Myeloid leukemiaD007951—C9262———7
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
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Ph 3
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Gastrointestinal stromal tumorsD046152EFO_0000505C49.A3————3
DiarrheaD003967—R19.71———23
Prostatic neoplasmsD011471—C612————2
InfectionsD007239EFO_0000544—2————2
Primary myelofibrosisD055728—D47.41————1
AnemiaD000740EFO_0004272D64.91————1
Leukemia myeloid chronic atypical bcr-abl negativeD054438—C92.21————1
Myeloid leukemia accelerated phaseD015465——1————1
ThrombocytosisD013922—D75.831————1
Skin neoplasmsD012878EFO_0004198C441————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
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Acquired immunodeficiency syndromeD000163EFO_0000765B20————22
AggressionD000374EFO_0003015—————11
Invasive hydatidiform moleD002820—D39.2————11
Juvenile arthritisD001171EFO_1002007M08————11
Pseudomyxoma peritoneiD011553EFO_0007456—————11
Vascular system injuriesD057772—T14.8————11
MicrobiotaD064307——————11
Immunologic deficiency syndromesD007153—D84.9————11
Healthy dietD000072001——————11
Ultrasonic therapyD014464——————11
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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
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Fusilev – Spectrum Pharmaceuticals
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Khapzory – Spectrum Pharmaceuticals
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Trends
PubMed Central
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Additional graphs summarizing 293 documents
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Safety
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4,798 adverse events reported
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