imiglucerase 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
enzymes 4932 154248-97-2

Description:

MoleculeDescription

Synonyms:

  • cerezyme
  • imiglucerase
  • imiglucerase for injection
  • glucosylceramidase
  • beta-glucocerebrosidase
  • D-glucosyl-N-acylsphingosine glucohydrolase
  • acid beta-glucosidase
A glycosidase that hydrolyzes a glucosylceramide to yield free ceramide plus glucose. Deficiency of this enzyme leads to abnormally high concentrations of glucosylceramide in the brain in GAUCHER DISEASE. EC 3.2.1.45.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
300 U P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Nov. 17, 1997 EMA Genzyme Europe B.V.
May 23, 1994 FDA GENZYME

FDA Adverse Event Reporting System (Female)

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
Exposure during pregnancy 175.69 21.67 117 3923 238293 90386114
Chitotriosidase increased 131.76 21.67 15 4025 4 90624403
Bone pain 103.68 21.67 52 3988 61931 90562476
Abortion spontaneous 101.28 21.67 49 3991 54007 90570400
Osteonecrosis 88.68 21.67 36 4004 26205 90598202
Bone infarction 71.49 21.67 13 4027 427 90623980
Seizure 62.87 21.67 53 3987 152576 90471831
Splenomegaly 58.77 21.67 22 4018 12902 90611505
Weight decreased 55.47 21.67 76 3964 379834 90244573
Poor venous access 49.98 21.67 22 4018 19505 90604902
Blood acid phosphatase increased 45.10 21.67 5 4035 0 90624407
Weight increased 44.32 21.67 72 3968 417855 90206552
Respiratory failure 40.45 21.67 37 4003 118381 90506026
Disease progression 38.71 21.67 41 3999 156574 90467833
Bone disorder 37.44 21.67 19 4021 23101 90601306
Cyanosis 34.49 21.67 17 4023 19438 90604969
Surgical procedure repeated 31.03 21.67 6 4034 276 90624131
Spleen disorder 27.53 21.67 7 4033 1134 90623273
Pregnancy 26.43 21.67 22 4018 62025 90562382
Drug ineffective 24.37 21.67 16 4024 1384282 89240125
Maternal exposure during pregnancy 24.16 21.67 51 3989 360012 90264395
Product dose omission issue 24.00 21.67 45 3995 291642 90332765
Angiotensin converting enzyme increased 23.24 21.67 4 4036 95 90624312
Parkinson's disease 22.95 21.67 6 4034 1084 90623323
Basophilia 22.66 21.67 3 4037 10 90624397
Hepatomegaly 21.71 21.67 11 4029 13315 90611092

FDA Adverse Event Reporting System (Male)

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
Osteonecrosis 72.57 24.57 30 2715 15835 42602755
Chitotriosidase increased 55.23 24.57 7 2738 8 42618582
Weight increased 53.95 24.57 49 2696 107934 42510656
Seizure 51.21 24.57 50 2695 120511 42498079
Poor venous access 48.25 24.57 18 2727 7234 42611356
Bone pain 40.92 24.57 23 2722 23769 42594821
Epilepsy 38.88 24.57 23 2722 26148 42592442
Respiratory failure 33.18 24.57 41 2704 128091 42490499
Status epilepticus 32.16 24.57 17 2728 15561 42603029
Splenomegaly 30.72 24.57 17 2728 17030 42601560
Disease progression 27.99 24.57 40 2705 143616 42474974
Femur fracture 26.97 24.57 13 2732 9799 42608791

FDA Adverse Event Reporting System (Geriatric)

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
Chitotriosidase increased 157.78 21.30 19 6162 12 110583106
Osteonecrosis 139.43 21.30 57 6124 33684 110549434
Exposure during pregnancy 121.34 21.30 89 6092 167335 110415783
Bone pain 109.23 21.30 59 6122 65074 110518044
Seizure 101.52 21.30 90 6091 221095 110362023
Abortion spontaneous 86.64 21.30 41 6140 34241 110548877
Bone infarction 70.21 21.30 14 6167 600 110582518
Poor venous access 67.12 21.30 31 6150 24491 110558627
Weight increased 66.04 21.30 98 6083 419546 110163572
Blood acid phosphatase increased 61.55 21.30 7 6174 0 110583118
Respiratory failure 58.59 21.30 66 6115 215266 110367852
Splenomegaly 49.03 21.30 25 6156 24473 110558645
Bone disorder 46.45 21.30 23 6158 21169 110561949
Product dose omission issue 43.33 21.30 70 6111 321712 110261406
Status epilepticus 43.08 21.30 25 6156 31546 110551572
Weight decreased 41.61 21.30 85 6096 467972 110115146
Disease progression 41.22 21.30 59 6122 243975 110339143
Spleen disorder 39.91 21.30 11 6170 1933 110581185
Cyanosis 36.52 21.30 22 6159 29719 110553399
Femur fracture 35.24 21.30 25 6156 44444 110538674
Pneumonia 34.21 21.30 117 6064 876597 109706521
Parkinson's disease 32.95 21.30 9 6172 1530 110581588
Illness 32.85 21.30 31 6150 82140 110500978
Off label use 32.73 21.30 22 6159 1500163 109082955
Drug ineffective 32.24 21.30 23 6158 1520517 109062601
Surgical procedure repeated 28.92 21.30 7 6174 738 110582380
Pyrexia 28.38 21.30 112 6069 898153 109684965
Myoclonic epilepsy 27.98 21.30 9 6172 2682 110580436
Exposure via breast milk 26.68 21.30 7 6174 1021 110582097
Epilepsy 26.00 21.30 30 6151 100179 110482939
Angiotensin converting enzyme increased 25.73 21.30 5 6176 187 110582931
Infantile apnoea 25.23 21.30 4 6177 44 110583074
Device related infection 24.12 21.30 19 6162 39500 110543618
Laryngospasm 23.14 21.30 9 6172 4659 110578459
Hepatosplenomegaly 22.92 21.30 10 6171 6909 110576209
Pregnancy 21.82 21.30 20 6161 51047 110532071
Hip fracture 21.67 21.30 17 6164 35134 110547984
Hepatomegaly 21.64 21.30 14 6167 21400 110561718

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB02 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Enzymes
FDA CS M0009360 Glucosylceramidase
FDA EPC N0000175820 Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
CHEBI has role CHEBI:75835 anti-anaemic agent

Related Drugs by ATC class:

A16AB Enzymes 24 drugs
agalsidase alfaagalsidase betaalglucerasealglucosidase alfaasfotase alfaavalglucosidase alfacerliponase alfacipaglucosidase alfaeladocagene exuparvovecelosulfase alfagalsulfaseidursulfase show all 24 →

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

DiseaseRelationSNOMED_IDDOID
Glucosylceramide beta-glucosidase deficiency indication 190794006 DOID:1926




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D03020 KEGG_DRUG
4020874 VANDF
CHEBI:749442 CHEBI
CHEMBL1201632 ChEMBL_ID
C090568 MESH_SUPPLEMENTAL_RECORD_UI
DB00053 DRUGBANK_ID
84958 RXNORM
123 MMSL
4868 MMSL
d04096 MMSL
004477 NDDF
109090004 SNOMEDCT_US
259429006 SNOMEDCT_US
386968002 SNOMEDCT_US
C0291140 UMLSCUI
7324 INN_ID
Q6U6J48BWY UNII
D005962 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cerezyme HUMAN PRESCRIPTION DRUG LABEL 1 58468-4663 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 40 U INTRAVENOUS BLA 28 sections