levofolinic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4384	80433-71-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: levoleucovorin calcium pentahydrate levoleucovorin calcium levofolinate levoleucovorin calcium levofolene L-Folinic acid levofolinic acid sodium levofolinate calcium levofolinate hydrate	A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN. Molecular weight: 473.45 Formula: C20H23N7O7 CLOGP: -1.98 LIPINSKI: 2 HAC: 14 HDO: 7 TPSA: 215.55 ALOGS: -3.20 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

levoleucovorin calcium pentahydrate
levoleucovorin
calcium levofolinate
levoleucovorin calcium
levofolene
L-Folinic acid
levofolinic acid
sodium levofolinate
calcium levofolinate hydrate

A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN.

Molecular weight: 473.45
Formula: C20H23N7O7
CLOGP: -1.98
LIPINSKI: 2
HAC: 14
HDO: 7
TPSA: 215.55
ALOGS: -3.20
ROTB: 9

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
30	mg	O
30	mg	P
30	mg	P

ADMET properties:

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Property	Value	Reference
CL (Clearance)	4.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	11.43 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	100 mg/mL	Bocci G, Oprea TI, Benet LZ
t_half (Half-life)	1.10 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
Vd (Volume of distribution)	0.27 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
March 7, 2008	FDA	SPECTRUM PHARMS
Sept. 21, 2018	PMDA	Pfizer Japan Inc.

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Neutrophil count decreased	251.82	29.87	115	5505	56291	63427111
Dermatitis acneiform	240.30	29.87	61	5559	4935	63478467
Paronychia	191.01	29.87	52	5568	5513	63477889
Neutropenia	138.02	29.87	118	5502	174887	63308515
Decreased appetite	128.29	29.87	133	5487	250919	63232483
Peripheral sensory neuropathy	116.83	29.87	38	5582	7413	63475989
Stomatitis	98.10	29.87	88	5532	138637	63344765
Hyperammonaemia	91.51	29.87	29	5591	5203	63478199
Diarrhoea	79.10	29.87	186	5434	715180	62768222
Mucosal inflammation	73.79	29.87	48	5572	46880	63436522

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Dermatitis acneiform	450.04	27.65	131	8808	6058	34941934
Paronychia	385.31	27.65	102	8837	3303	34944689
Interstitial lung disease	300.32	27.65	194	8745	65088	34882904
Neutrophil count decreased	245.05	27.65	156	8783	50948	34897044
Peripheral sensory neuropathy	240.44	27.65	83	8856	6677	34941315
Stomatitis	206.75	27.65	131	8808	42383	34905609
Neuropathy peripheral	179.01	27.65	157	8782	83106	34864886
Decreased appetite	162.97	27.65	206	8733	166186	34781806
Neutropenia	136.10	27.65	183	8756	156595	34791397
Hypomagnesaemia	133.50	27.65	78	8861	21773	34926219

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Dermatitis acneiform	643.51	25.19	178	14114	9815	79720281
Paronychia	511.48	25.19	141	14151	7667	79722429
Neutrophil count decreased	459.54	25.19	256	14036	93703	79636393
Interstitial lung disease	324.75	25.19	219	14073	112381	79617715
Peripheral sensory neuropathy	316.48	25.19	110	14182	12923	79717173
Neutropenia	289.17	25.19	304	13988	287406	79442690
Decreased appetite	280.58	25.19	325	13967	342093	79388003
Neuropathy peripheral	260.74	25.19	210	14082	141095	79589001
Stomatitis	249.59	25.19	208	14084	146549	79583547
Hyperammonaemia	185.02	25.19	71	14221	11022	79719074

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	V03AF04	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Detoxifying agents for antineoplastic treatment
ATC	V03AF10	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Detoxifying agents for antineoplastic treatment
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:35610	antineoplastic agents
FDA CS	M0008658	Folic Acid
FDA EPC	N0000178369	Folate Analog
MeSH PA	D000931	Antidotes
MeSH PA	D020011	Protective Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Megaloblastic anemia	indication	53165003	DOID:13382
Folic acid deficiency	indication	190633005
Malignant tumor of stomach	indication	363349007	DOID:10534
Small intestine cancer	indication	363509000	DOID:10154
Methotrexate Toxicity	indication
Adjunct to Fluorouracil Treatment of Colorectal Cancer	indication
Pyrimethamine Toxicity	indication
Trimethoprim Toxicity	indication
Sulfadiazine Toxicity	indication
Trimetrexate Toxicity	indication

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.61	acidic
pKa2	5.29	acidic
pKa3	10.26	acidic
pKa4	12.96	acidic
pKa5	4.59	Basic
pKa6	2.23	Basic

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Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

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ID	Source
005532	NDDF
005533	NDDF
132962	MMSL
135398559	PUBCHEM_CID
1648126	RXNORM
21723	MMSL
25218	MMSL
35726	MMSL
395769006	SNOMEDCT_US
4028507	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Biopar delta-FORTE	HUMAN PRESCRIPTION DRUG LABEL	6	64661-793	CAPSULE	2.50 mg	ORAL	unapproved drug other	11 sections
Biopar delta-FORTE	HUMAN PRESCRIPTION DRUG LABEL	6	64661-793	CAPSULE	2.50 mg	ORAL	unapproved drug other	11 sections
Biopar delta-FORTE	HUMAN PRESCRIPTION DRUG LABEL	6	64661-793	CAPSULE	2.50 mg	ORAL	unapproved drug other	11 sections
Fusilev	Human Prescription Drug Label	1	72893-009	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	NDA	23 sections
Fusilev	Human Prescription Drug Label	1	72893-009	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	NDA	23 sections
Levoleucovorin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9558	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	ANDA	23 sections
Levoleucovorin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3201	INJECTION, SOLUTION	175 mg	INTRAVENOUS	ANDA	23 sections
LEVOLEUCOVORIN	HUMAN PRESCRIPTION DRUG LABEL	1	16714-890	INJECTION, SOLUTION	175 mg	INTRAVENOUS	ANDA	25 sections
LEVOLEUCOVORIN	HUMAN PRESCRIPTION DRUG LABEL	1	16714-915	INJECTION, SOLUTION	250 mg	INTRAVENOUS	ANDA	25 sections
LEVOLEUCOVORIN	HUMAN PRESCRIPTION DRUG LABEL	1	43598-771	INJECTION, SOLUTION	175 mg	INTRAVENOUS	ANDA	25 sections

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