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

Stem definition	Drug id	CAS RN
arabinofuranosyl derivatives	1892	121032-29-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nelarabine arranon nelzarabine atriance	prodrug of ara-G Molecular weight: 297.27 Formula: C11H15N5O5 CLOGP: -0.39 LIPINSKI: 0 HAC: 10 HDO: 4 TPSA: 148.77 ALOGS: -1.33 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

nelarabine
arranon
nelzarabine
atriance

prodrug of ara-G

Molecular weight: 297.27
Formula: C11H15N5O5
CLOGP: -0.39
LIPINSKI: 0
HAC: 10
HDO: 4
TPSA: 148.77
ALOGS: -1.33
ROTB: 3

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
CL (Clearance)	81 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	6.60 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	4.90 L/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.23 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	2.97 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability)	11 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma)	0.80 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.50 hours	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Aug. 22, 2007	EMA	Sandoz Pharmaceuticals d.d.
Oct. 28, 2005	FDA	NOVARTIS PHARMS CORP

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
Subacute combined cord degeneration	94.41	46.91	12	461	218	63488331
Myelopathy	90.43	46.91	16	457	2810	63485739
Peripheral motor neuropathy	50.30	46.91	9	464	1672	63486877
Sepsis	47.74	46.91	23	450	153100	63335449

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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
Myelopathy	80.88	40.26	19	1384	2478	34953050
Neuropathy peripheral	55.71	40.26	37	1366	83226	34872302
Peripheral sensory neuropathy	53.71	40.26	17	1386	6743	34948785
Leukoencephalopathy	48.06	40.26	14	1389	4201	34951327
Guillain-Barre syndrome	47.08	40.26	15	1388	6072	34949456
Polyneuropathy	43.99	40.26	18	1385	14878	34940650
West Nile viral infection	42.40	40.26	9	1394	738	34954790
Ataxia	41.80	40.26	17	1386	13836	34941692
Febrile neutropenia	41.37	40.26	38	1365	136811	34818717

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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
Myelopathy	164.55	41.38	34	1691	4599	79738064
Subacute combined cord degeneration	91.74	41.38	14	1711	327	79742336
Peripheral sensory neuropathy	83.11	41.38	24	1701	13009	79729654
Febrile neutropenia	73.09	41.38	51	1674	230948	79511715
Neurotoxicity	68.75	41.38	26	1699	32492	79710171
Neuropathy peripheral	66.32	41.38	40	1685	141265	79601398
Muscular weakness	54.30	41.38	37	1688	160692	79581971
Polyneuropathy	49.90	41.38	19	1706	24132	79718531
Peripheral motor neuropathy	49.37	41.38	12	1713	3355	79739308
West Nile viral infection	45.31	41.38	9	1716	993	79741670

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01BB07	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ANTIMETABOLITES Purine analogues
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:59517	DNA synthesis inhibitors
FDA EPC	N0000175595	Nucleoside Metabolic Inhibitor
FDA MoA	N0000000233	Nucleic Acid Synthesis Inhibitors

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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
T-cell acute lymphoblastic leukemia	indication	277575008
Precursor T-cell lymphoblastic lymphoma	indication	421246008
Hyperbilirubinemia	contraindication	14783006	DOID:2741
Peripheral demyelinating neuropathy	contraindication	23414001	DOID:5214
Demyelination	contraindication	32693004
Dehydration	contraindication	34095006
Mental handicap	contraindication	47437004
Hepatic failure	contraindication	59927004
Seizure disorder	contraindication	128613002
Intrathecal injection of chemotherapeutic agent	contraindication	171765004

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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	11.67	acidic
pKa2	12.33	acidic
pKa3	13.34	acidic
pKa4	3.39	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
011068	NDDF
0Z99WX0GPF	UNII
135499520	PUBCHEM_CID
20608	MMSL
274771	RXNORM
3011155	PUBCHEM_CID
354214	MMSL
38819-10-2	SECONDARY_CAS_RN
4025093	VUID
4025093	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Arranon	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0683	INJECTION	5 mg	INTRAVENOUS	NDA	31 sections
Arranon	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0683	INJECTION	5 mg	INTRAVENOUS	NDA	31 sections
Nelarabine	HUMAN PRESCRIPTION DRUG LABEL	1	43598-142	INJECTION	5 mg	INTRAVENOUS	ANDA	28 sections
Nelarabine	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1743	INJECTION	5 mg	INTRAVENOUS	ANDA	28 sections
Nelarabine	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1726	INJECTION	5 mg	INTRAVENOUS	ANDA	26 sections
Nelarabine	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1726	INJECTION	5 mg	INTRAVENOUS	ANDA	26 sections
Nelarabine	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1839	INJECTION	5 mg	INTRAVENOUS	ANDA	26 sections
Nelarabine	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1685	INJECTION	5 mg	INTRAVENOUS	ANDA	1 sections
Nelarabine	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1685	INJECTION	5 mg	INTRAVENOUS	ANDA	1 sections
Nelarabine	HUMAN PRESCRIPTION DRUG LABEL	1	71288-165	INJECTION	5 mg	INTRAVENOUS	ANDA	28 sections

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