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

Stem definition	Drug id	CAS RN
arabinofuranosyl derivatives	1189	75607-67-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fludarabine 5'-monophosphate fludarabine phosphate fludura fludara 2-F-ara-AMP	Molecular weight: 365.21 Formula: C10H13FN5O7P CLOGP: -3.13 LIPINSKI: 1 HAC: 12 HDO: 5 TPSA: 186.07 ALOGS: -2.09 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fludarabine 5'-monophosphate
fludarabine phosphate
fludura
fludara
2-F-ara-AMP

Molecular weight: 365.21
Formula: C10H13FN5O7P
CLOGP: -3.13
LIPINSKI: 1
HAC: 12
HDO: 5
TPSA: 186.07
ALOGS: -2.09
ROTB: 4

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
S (Water solubility)	9.20 mg/mL	Bocci G, Oprea TI, Benet LZ
BA (Bioavailability)	57.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.66 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
April 18, 1991	FDA
Jan. 26, 2007	PMDA	Nihon Schering K.K.

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
Cytokine release syndrome	2067.80	23.05	611	33920	13703	63440788
Acute graft versus host disease	1258.28	23.05	322	34209	4106	63450385
Cytomegalovirus infection	1015.52	23.05	394	34137	20558	63433933
Febrile neutropenia	841.38	23.05	615	33916	117834	63336657
Graft versus host disease	830.49	23.05	255	34276	6508	63447983
Acute graft versus host disease in skin	768.96	23.05	207	34324	3245	63451246
Chronic graft versus host disease	667.41	23.05	181	34350	2921	63451570
Adenovirus infection	660.38	23.05	185	34346	3386	63451105
Cytomegalovirus infection reactivation	654.73	23.05	188	34343	3775	63450716
Graft versus host disease in skin	632.00	23.05	171	34360	2734	63451757

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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
Cytokine release syndrome	2231.30	18.17	942	50880	21935	34883174
Acute graft versus host disease	1229.66	18.17	434	51388	6069	34899040
Cytomegalovirus infection	1063.82	18.17	592	51230	25543	34879566
Acute graft versus host disease in skin	1032.59	18.17	360	51462	4841	34900268
Hypogammaglobulinaemia	790.92	18.17	330	51492	7410	34897699
Graft versus host disease	722.98	18.17	340	51482	10229	34894880
Febrile neutropenia	663.53	18.17	910	50912	135939	34769170
Graft versus host disease in gastrointestinal tract	628.82	18.17	228	51594	3455	34901654
Chronic graft versus host disease	615.74	18.17	235	51587	4138	34900971
Adenovirus infection	608.10	18.17	245	51577	5012	34900097

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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
Cytokine release syndrome	4096.70	17.72	1489	78597	34509	79629793
Acute graft versus host disease	2378.90	17.72	725	79361	9442	79654860
Cytomegalovirus infection	2148.70	17.72	984	79102	41660	79622642
Acute graft versus host disease in skin	1761.04	17.72	539	79547	7119	79657183
Graft versus host disease	1487.97	17.72	562	79524	14464	79649838
Febrile neutropenia	1371.65	17.72	1408	78678	229591	79434711
Adenovirus infection	1263.72	17.72	429	79657	8018	79656284
Chronic graft versus host disease	1228.85	17.72	398	79688	6383	79657919
Hypogammaglobulinaemia	1151.82	17.72	448	79638	12503	79651799
Venoocclusive liver disease	1121.09	17.72	428	79658	11343	79652959

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01BB05	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ANTIMETABOLITES Purine analogues
CHEBI has role	CHEBI:22587	antiviral agents
CHEBI has role	CHEBI:35221	antimetabolite
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35705	immunosuppressive 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
MeSH PA	D000970	Antineoplastic 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
Acute myeloid leukemia, disease	indication	91861009
Chronic lymphoid leukemia, disease	indication	92814006
Low-grade B cell non-Hodgkin lymphoma	indication	118601006
Mantle cell lymphoma	indication	443487006
Acute myeloid leukemia, disease	off-label use	91861009
Waldenström macroglobulinemia	off-label use	190818004	DOID:0050747
Follicular non-Hodgkin's lymphoma	off-label use	308121000
Mycosis	contraindication	3218000	DOID:1564
Herpes zoster	contraindication	4740000	DOID:8536
Acquired hemolytic anemia	contraindication	4854004

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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	1.31	acidic
pKa2	6.36	acidic
pKa3	12.46	acidic
pKa4	13.04	acidic
pKa5	2.93	Basic
pKa6	2.33	Basic

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Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
DNA polymerase alpha catalytic subunit	Enzyme	P09884	DPOLA_HUMAN	INHIBITOR			WOMBAT-PK	DRUG LABEL
Ribonucleoside-diphosphate reductase subunit M2	Enzyme	P31350	RIR2_HUMAN	INHIBITOR	IC50	6	IUPHAR
Carbonic anhydrase 5A, mitochondrial	Enzyme	P35218	CAH5A_HUMAN		Ki	6.88	CHEMBL
Ribonucleoside-diphosphate reductase large subunit	Enzyme	P23921	RIR1_HUMAN	INHIBITOR	IC50	6	IUPHAR
Adenosine receptor A2a	GPCR		AA2AR_RAT		Ki	7.55	CHEMBL
Adenosine receptor A3	GPCR		AA3R_RAT		Ki	4.98	CHEMBL
Adenosine receptor A1	GPCR		AA1R_RAT		Ki	8.23	CHEMBL

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External reference:

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ID	Source
003618	NDDF
004817	NDDF
108763009	SNOMEDCT_US
108765002	SNOMEDCT_US
110964	MMSL
1862	MMSL
1X9VK9O1SC	UNII
21679-14-1	SECONDARY_CAS_RN
24698	RXNORM
30751	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fludarabine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-192	INJECTION, SOLUTION	25 mg	INTRAVENOUS	ANDA	14 sections
Fludarabine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0480-9772	INJECTION, SOLUTION	25 mg	INTRAVENOUS	Unapproved drug for use in drug shortage	3 sections
Fludarabine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1242	INJECTION	25 mg	INTRAVENOUS	ANDA	28 sections
FLUDARABINE PHOSPHATE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-131	INJECTION	25 mg	INTRAVENOUS	Unapproved drug for use in drug shortage	2 sections
FLUDARABINE PHOSPHATE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-131	INJECTION	25 mg	INTRAVENOUS	Unapproved drug for use in drug shortage	2 sections
fludarabine phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	24201-237	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	24 sections
fludarabine phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	24201-237	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	24 sections
Fludarabine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	25021-242	INJECTION, SOLUTION	25 mg	INTRAVENOUS	ANDA	28 sections
Fludarabine Phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	25021-242	INJECTION, SOLUTION	25 mg	INTRAVENOUS	ANDA	28 sections
Fludarabine phosphate	HUMAN PRESCRIPTION DRUG LABEL	1	45963-609	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	ANDA	21 sections

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