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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
1239 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——80250140420454
Rectal neoplasmsD012004——39914715171
Colonic neoplasmsD003110—C1839765717162
Pancreatic neoplasmsD010190EFO_0003860C2553903317160
AdenocarcinomaD000230——21742016111
Stomach neoplasmsD013274EFO_0003897C1624631915101
Neoplasm metastasisD009362EFO_0009708—1739151471
Esophageal neoplasmsD004938—C15153641249
Liver neoplasmsD008113EFO_1001513C22.071891436
CholangiocarcinomaD018281—C22.141621—22
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80626325—4139
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.0143324—367
LymphomaD008223—C85.983714—659
CarcinomaD002277—C80.082714—448
LeukemiaD007938—C9542816—247
Pancreatic ductal carcinomaD021441——15195—135
Hepatocellular carcinomaD006528—C22.07188—232
Burkitt lymphomaD002051—C83.75158——27
Non-hodgkin lymphomaD008228—C85.9797—224
Hiv infectionsD015658EFO_0000764B20528—924
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
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Total
Myeloid leukemia acuteD015470—C92.093———11
Ovarian neoplasmsD010051EFO_0003893C5656———11
Myelodysplastic syndromesD009190—D4683———10
Mantle-cell lymphomaD020522—C83.137———10
Hodgkin diseaseD006689—C8164———9
SarcomaD012509——36———9
OsteosarcomaD012516——35——18
B-cell chronic lymphocytic leukemiaD015451—C91.143———7
Rheumatoid arthritisD001172EFO_0000685M06.926———7
Breast neoplasmsD001943EFO_0003869C5024———6
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
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Gastrointestinal stromal tumorsD046152EFO_0000505C49.A4————4
Immunoblastic lymphadenopathyD007119EFO_1001350C86.52———13
DiarrheaD003967—R19.71———12
Sezary syndromeD012751—C84.11———12
T-cell lymphoma cutaneousD016410—C84.A1———12
Pseudomyxoma peritoneiD011553EFO_0007456—1———12
Prostatic neoplasmsD011471—C611————1
AnemiaD000740EFO_0004272D64.91————1
ThrombocytosisD013922—D75.831————1
Skin neoplasmsD012878EFO_0004198C441————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
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AggressionD000374EFO_0003015—————11
Invasive hydatidiform moleD002820—D39.2————11
Juvenile arthritisD001171EFO_1002007M08————11
BehaviorD001519GO_0007610STY/T053————11
MicrobiotaD064307——————11
Healthy dietD000072001——————11
Ultrasonic therapyD014464——————11
Multiple primary neoplasmsD009378——————11
OverweightD050177—E66.3————11
Liver cirrhosisD008103EFO_0001422K74.0————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
No data
Variants
No data
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Fusilev – Spectrum Pharmaceuticals
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Khapzory – Spectrum Pharmaceuticals
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 207 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,892 adverse events reported
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