mycophenolate mofetil indications/contra

Stem definitionDrug idCAS RN
1859 128794-94-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • linfonex
  • RS-61443
  • myclausen
  • mycophenolate mofetil
  • mycophenolate mofetil hydrochloride
  • myfenax
  • mycophenolate mofetil HCl
  • Molecular weight: 433.50
  • Formula: C23H31NO7
  • CLOGP: 2.98
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 94.53
  • ALOGS: -3.66
  • ROTB: 10

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
May 3, 1995 FDA ROCHE PALO

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytomegalovirus infection 4313.23 34.27 921 15396 3586 3365956
Transplant rejection 4053.68 34.27 771 15546 1340 3368202
Kidney transplant rejection 1919.04 34.27 397 15920 1246 3368296
Pyrexia 1602.72 34.27 885 15432 80230 3289312
Off label use 1577.96 34.27 767 15550 53210 3316332
Diarrhoea 1471.80 34.27 915 15402 103433 3266109
Sepsis 1393.98 34.27 603 15714 31770 3337772
Leukopenia 1350.20 34.27 484 15833 15339 3354203
Polyomavirus-associated nephropathy 1335.05 34.27 236 16081 190 3369352
Post transplant lymphoproliferative disorder 1269.39 34.27 248 16069 520 3369022
Blood creatinine increased 1251.02 34.27 499 15818 21319 3348223
Multiple organ dysfunction syndrome 1162.25 34.27 423 15894 13987 3355555
Renal impairment 1092.84 34.27 431 15886 17830 3351712
Transplant dysfunction 1084.04 34.27 201 16116 271 3369271
Complications of transplanted kidney 1024.30 34.27 209 16108 595 3368947
Pneumonia 1014.81 34.27 627 15690 69516 3300026
Epstein-Barr virus infection 930.91 34.27 221 16096 1477 3368065
BK virus infection 926.33 34.27 180 16137 361 3369181
Cytomegalovirus viraemia 877.17 34.27 182 16135 577 3368965
Anaemia 854.69 34.27 513 15804 53820 3315722
Respiratory failure 839.51 34.27 383 15934 22758 3346784
Pancytopenia 806.01 34.27 350 15967 18470 3351072
Septic shock 786.09 34.27 304 16013 11880 3357662
Graft versus host disease 784.54 34.27 209 16108 2338 3367204
Infection 771.82 34.27 372 15945 25030 3344512
Agranulocytosis 747.15 34.27 237 16080 5075 3364467
Urinary tract infection 743.56 34.27 388 15929 30940 3338602
Neutropenia 734.39 34.27 393 15924 32993 3336549
Acute kidney injury 716.36 34.27 444 15873 49239 3320303
Aspergillus infection 619.04 34.27 161 16156 1626 3367916

Pharmacologic Action:

None

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Prevention of Cardiac Transplant Rejection indication
Prevention of Kidney Transplant Rejection indication
Prevention of Liver Transplant Rejection indication
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
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Acute infectious disease contraindication 63171007
Gastrointestinal hemorrhage contraindication 74474003
Herpes simplex contraindication 88594005 DOID:8566
Malignant lymphoma contraindication 118600007 DOID:0060058
Deficiency of hypoxanthine phosphoribosyltransferase contraindication 124275001 DOID:1919
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Primary malignant neoplasm contraindication 372087000
Malignant neoplasm of skin contraindication 372130007 DOID:4159
Breastfeeding (mother) contraindication 413712001
BK Polyomavirus Reactivation Nephropathy contraindication
Opportunistic Fungal Infection contraindication
Prevention of Lung Transplant Rejection off-label use

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (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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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Inosine-5'-monophosphate dehydrogenase 2 Enzyme INHIBITOR Ki 8.15 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Inosine-5'-monophosphate dehydrogenase 1 Enzyme INHIBITOR Ki 7.48 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE

External reference:

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IDSource
4020921 VUID
N0000148406 NUI
C0209368 UMLSCUI
6831 IUPHAR_LIGAND_ID
D00752 KEGG_DRUG
DB00688 DRUGBANK_ID
164451 MMSL
N0000148406 NDFRT
005014 NDDF
d03839 MMSL
5141 MMSL
68149 RXNORM
109131004 SNOMEDCT_US
386976000 SNOMEDCT_US
4020921 VANDF
N0000005137 NDFRT
9242ECW6R0 UNII
CHEMBL1456 ChEMBL_ID
5281078 PUBCHEM_CID
CHEMBL1200955 ChEMBL_ID
116680-01-4 SECONDARY_CAS_RN
DB01024 DRUGBANK_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
CellCept HUMAN PRESCRIPTION DRUG LABEL 1 0004-0259 CAPSULE 250 mg ORAL NDA 15 sections
CellCept HUMAN PRESCRIPTION DRUG LABEL 1 0004-0260 TABLET, FILM COATED 500 mg ORAL NDA 15 sections
CellCept HUMAN PRESCRIPTION DRUG LABEL 1 0004-0261 POWDER, FOR SUSPENSION 200 mg ORAL NDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 0054-0163 CAPSULE 250 mg ORAL ANDA 16 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 0054-0166 TABLET 500 mg ORAL ANDA 16 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 0093-7334 CAPSULE 250 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 0093-7477 TABLET, FILM COATED 500 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-2250 CAPSULE 250 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-4472 TABLET, FILM COATED 500 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 0781-2067 CAPSULE 250 mg ORAL ANDA 16 sections
Mycophenolate mofetil HUMAN PRESCRIPTION DRUG LABEL 1 0781-5175 TABLET 500 mg ORAL ANDA 13 sections
mycophenolate mofetil HUMAN PRESCRIPTION DRUG LABEL 1 16729-019 TABLET 500 mg ORAL ANDA 15 sections
mycophenolate mofetil HUMAN PRESCRIPTION DRUG LABEL 1 16729-094 CAPSULE 250 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 17478-422 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 17478-957 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 15 sections
CellCept HUMAN PRESCRIPTION DRUG LABEL 1 21695-171 CAPSULE 250 mg ORAL NDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 42023-172 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 14 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 42658-101 TABLET, FILM COATED 500 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 42658-501 CAPSULE 250 mg ORAL ANDA 15 sections
CellCept HUMAN PRESCRIPTION DRUG LABEL 1 49999-936 CAPSULE 250 mg ORAL NDA 15 sections
CellCept HUMAN PRESCRIPTION DRUG LABEL 1 49999-937 TABLET, FILM COATED 500 mg ORAL NDA 15 sections
Mycophenolate mofetil HUMAN PRESCRIPTION DRUG LABEL 1 50090-2246 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
Mycophenolate mofetil HUMAN PRESCRIPTION DRUG LABEL 1 50268-581 TABLET, FILM COATED 500 mg ORAL ANDA 20 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 51079-379 TABLET, FILM COATED 500 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 51079-721 CAPSULE 250 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 55154-5382 TABLET, FILM COATED 500 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 55154-6262 CAPSULE 250 mg ORAL ANDA 15 sections
mycophenolate mofetil HUMAN PRESCRIPTION DRUG LABEL 1 59762-0703 CAPSULE 250 mg ORAL ANDA 13 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 60429-059 CAPSULE 250 mg ORAL ANDA 15 sections
Mycophenolate Mofetil HUMAN PRESCRIPTION DRUG LABEL 1 60429-070 TABLET, FILM COATED 500 mg ORAL ANDA 15 sections