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

Stem definition	Drug id	CAS RN
	1859	128794-94-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: linfonex RS-61443 myclausen mycophenolate mofetil mycophenolate mofetil hydrochloride myfenax mycophenolate mofetil HCl	Mycophenolate mofetil is a prodrug of mycophenolic acid, an inhibitor of inosine-5'-monophosphate dehydrogenase. MPA depletes guanosine nucleotides preferentially in T and B lymphocytes and inhibits their proliferation. Molecular weight: 433.50 Formula: C23H31NO7 CLOGP: 2.78 LIPINSKI: 0 HAC: 8 HDO: 1 TPSA: 94.53 ALOGS: -3.66 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

linfonex
RS-61443
myclausen
mycophenolate mofetil
mycophenolate mofetil hydrochloride
myfenax
mycophenolate mofetil HCl

Mycophenolate mofetil is a prodrug of mycophenolic acid, an inhibitor of inosine-5'-monophosphate dehydrogenase. MPA depletes guanosine nucleotides preferentially in T and B lymphocytes and inhibits their proliferation.

Molecular weight: 433.50
Formula: C23H31NO7
CLOGP: 2.78
LIPINSKI: 0
HAC: 8
HDO: 1
TPSA: 94.53
ALOGS: -3.66
ROTB: 10

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	47.45 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.04 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

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Date	Agency	Company
Feb. 14, 1998	EMA	Roche Registration GmbH
June 25, 2021	PMDA	CHUGAI PHARMACEUTICAL Co., Ltd
May 3, 1995	FDA	ROCHE PALO

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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
Transplant rejection	3185.11	10.81	1085	126786	9695	63351456
Cytomegalovirus infection	2651.60	10.81	1136	126735	19816	63341335
Post transplant lymphoproliferative disorder	1602.26	10.81	536	127335	4495	63356656
Off label use	1512.15	10.81	3820	124051	670642	62690509
Product use in unapproved indication	1491.66	10.81	1818	126053	177262	63183889
Transplant dysfunction	1452.66	10.81	494	127377	4378	63356773
Kidney transplant rejection	1083.83	10.81	384	127487	3887	63357264
Epstein-Barr virus infection	1029.33	10.81	440	127431	7610	63353541
Thrombotic microangiopathy	875.69	10.81	427	127444	10134	63351017
Cytomegalovirus viraemia	729.57	10.81	311	127560	5338	63355813

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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
Cytomegalovirus infection	2741.07	11.78	1484	121695	24651	34809101
Transplant rejection	2647.94	11.78	1087	122092	9224	34824528
Product use in unapproved indication	1533.11	11.78	1974	121205	115525	34718227
Post transplant lymphoproliferative disorder	1420.45	11.78	612	122567	5916	34827836
Kidney transplant rejection	1310.89	11.78	603	122576	6894	34826858
Polyomavirus-associated nephropathy	1300.76	11.78	495	122684	3349	34830403
Complications of transplanted kidney	914.48	11.78	405	122774	4204	34829548
BK virus infection	896.31	11.78	427	122752	5311	34828441
Acute graft versus host disease	770.23	11.78	401	122778	6102	34827650
Epstein-Barr virus infection	753.80	11.78	417	122762	7211	34826541

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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
Transplant rejection	5297.46	10.40	2021	226948	17416	79498003
Cytomegalovirus infection	5055.09	10.40	2460	226509	40184	79475235
Product use in unapproved indication	3166.89	10.40	3740	225229	246619	79268800
Post transplant lymphoproliferative disorder	2837.64	10.40	1112	227857	10352	79505067
Kidney transplant rejection	2053.42	10.40	854	228115	9392	79506027
Polyomavirus-associated nephropathy	2027.22	10.40	719	228250	4908	79510511
Transplant dysfunction	1934.45	10.40	742	228227	6479	79508940
Off label use	1913.56	10.40	6316	222653	900899	78614520
Epstein-Barr virus infection	1617.79	10.40	802	228167	13614	79501805
BK virus infection	1532.33	10.40	664	228305	8140	79507279

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
CHEBI has role	CHEBI:35705	immunosuppressive agents
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:53746	EC 1.1.1.205 inhibitor
CHEBI has role	CHEBI:149553	anticoronaviral drug
CHEBI has role	CHEBI:25442	mycotoxins
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:76964	Penicillium metabolites
CHEBI has role	CHEBI:78298	environmental contaminants

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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
The suppression of graft-versus-host disease in hematopoietic stem cell transplantation	indication	234646005
Prevention of Cardiac Transplant Rejection	indication
Prevention of Liver Transplant Rejection	indication
Prevention of Kidney Transplant Rejection	indication
Prevention of Lung Transplant Rejection	off-label use
Herpes zoster	contraindication	4740000	DOID:8536
Progressive multifocal leukoencephalopathy	contraindication	22255007	DOID:643
Cytomegalovirus infection	contraindication	28944009
Constitutional aplastic anemia	contraindication	28975000	DOID:1342
Gastrointestinal ulcer	contraindication	40845000

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.03	acidic
pKa2	6.33	Basic

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])	Mechanism action	Bioact source	MoA source
Inosine-5'-monophosphate dehydrogenase 1	Enzyme	P20839	IMDH1_HUMAN	INHIBITOR	Ki	7.48		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Inosine-5'-monophosphate dehydrogenase 2	Enzyme	P12268	IMDH2_HUMAN	INHIBITOR	Ki	8.16		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

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External reference:

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ID	Source
MOA	PDB_CHEM_ID
005013	NDDF
005014	NDDF
007639	NDDF
116680-01-4	SECONDARY_CAS_RN
164451	MMSL
18132	MMSL
210716	MMSL
237112	RXNORM
24280-93-1	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0259	CAPSULE	250 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0259	CAPSULE	250 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0259	CAPSULE	250 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0260	TABLET, FILM COATED	500 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0260	TABLET, FILM COATED	500 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0260	TABLET, FILM COATED	500 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0261	POWDER, FOR SUSPENSION	200 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0261	POWDER, FOR SUSPENSION	200 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0261	POWDER, FOR SUSPENSION	200 mg	ORAL	NDA	36 sections
CellCept	HUMAN PRESCRIPTION DRUG LABEL	1	0004-0298	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	36 sections

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