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

Stem definitionDrug idCAS RN
enzymes 5018 None

Description:

MoleculeDescription

Synonyms:

  • agalsidase beta
  • agalsidase beta (genetical recombination)
  • fabrazyme
recombinant protein for treatment of Fabry disease
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
5 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Aug. 3, 2001 EMA SANOFI B.V.
April 24, 2003 FDA GENZYME
Jan. 29, 2004 PMDA Genzyme Japan

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
Intentional dose omission 88.10 24.79 28 3525 8047 63477422
Product dose omission issue 85.84 24.79 84 3469 234229 63251240
Antibody test 82.62 24.79 10 3543 7 63485462
Globotriaosylsphingosine increased 70.34 24.79 8 3545 0 63485469
Globotriaosylceramide increased 70.34 24.79 8 3545 0 63485469
COVID-19 68.41 24.79 54 3499 113049 63372420
Exposure during pregnancy 57.27 24.79 56 3497 155491 63329978
Infusion site extravasation 54.89 24.79 21 3532 10405 63475064
Antibody test negative 48.52 24.79 7 3546 38 63485431
Illness 47.00 24.79 31 3522 49028 63436441
SARS-CoV-2 test positive 45.20 24.79 17 3536 8039 63477430
Malaise 45.03 24.79 82 3471 415872 63069597
Poor venous access 44.58 24.79 20 3533 14765 63470704
Cardiac disorder 38.97 24.79 28 3525 50788 63434681
Drug ineffective 36.99 24.79 7 3546 1044758 62440711
Drug specific antibody absent 36.18 24.79 6 3547 89 63485380
Pruritus 30.22 24.79 64 3489 361389 63124080
Cerebrovascular accident 29.16 24.79 33 3520 107991 63377478
Weight increased 26.34 24.79 50 3503 260742 63224727
Chest pain 25.09 24.79 44 3509 215915 63269554
Off label use 24.93 24.79 4 3549 674458 62811011

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
Chills 513.68 23.67 288 8050 80755 34867838
Infusion related reaction 257.35 23.67 159 8179 52898 34895695
Renal transplant 173.01 23.67 47 8291 1802 34946791
Drug specific antibody present 171.30 23.67 53 8285 3232 34945361
Globotriaosylceramide increased 154.19 23.67 21 8317 0 34948593
End stage renal disease 116.81 23.67 52 8286 8809 34939784
Flushing 89.97 23.67 69 8269 32351 34916242
Globotriaosylsphingosine increased 88.10 23.67 12 8326 0 34948593
Urticaria 87.21 23.67 90 8248 62287 34886306
Antibody test positive 82.01 23.67 21 8317 637 34947956
Chronic kidney disease 77.47 23.67 70 8268 41140 34907453
Pyrexia 72.67 23.67 208 8130 332805 34615788
Feeling cold 70.18 23.67 39 8299 10600 34937993
Drug ineffective 68.87 23.67 13 8325 456738 34491855
Cerebrovascular accident 63.37 23.67 89 8249 84722 34863871
Off label use 63.08 23.67 12 8326 419512 34529081
Pain 55.75 23.67 139 8199 204536 34744057
Angiokeratoma 55.19 23.67 10 8328 52 34948541
Paraesthesia 54.98 23.67 72 8266 64100 34884493
Chest discomfort 54.37 23.67 66 8272 54464 34894129
Vomiting 52.23 23.67 153 8185 247468 34701125
Illness 51.72 23.67 35 8303 13494 34935099
Body temperature increased 48.22 23.67 37 8301 17331 34931262
Throat tightness 48.02 23.67 28 8310 8330 34940263
Nausea 46.87 23.67 182 8156 339726 34608867
Pain in extremity 46.71 23.67 97 8241 126416 34822177
Drug specific antibody absent 45.18 23.67 9 8329 83 34948510
Antibody test negative 44.41 23.67 7 8331 12 34948581
Haemodialysis 42.08 23.67 28 8310 10498 34938095
Infusion site extravasation 40.26 23.67 20 8318 4324 34944269
Drug interaction 39.64 23.67 4 8334 225942 34722651
Tremor 38.61 23.67 70 8268 82517 34866076
Neutralising antibodies positive 38.24 23.67 8 8330 96 34948497
Acute kidney injury 37.58 23.67 13 8325 304975 34643618
Burning sensation 36.02 23.67 32 8306 18362 34930231
Blood immunoglobulin G increased 35.89 23.67 12 8326 936 34947657
Headache 34.84 23.67 116 8222 200519 34748074
Toxicity to various agents 33.98 23.67 4 8334 200358 34748235
Cardiac disorder 33.26 23.67 46 8292 43080 34905513
Infusion site reaction 32.78 23.67 11 8327 868 34947725
Transient ischaemic attack 30.10 23.67 35 8303 27578 34921015
Blood pressure increased 29.53 23.67 65 8273 88037 34860556
Atrial fibrillation 28.99 23.67 79 8259 122314 34826279
Peritoneal dialysis 28.39 23.67 9 8329 593 34948000
Product dose omission issue 28.08 23.67 77 8261 119634 34828959
Antibody test 27.13 23.67 4 8334 3 34948590
Feeling hot 27.10 23.67 28 8310 19344 34929249
Dialysis 27.07 23.67 22 8316 11186 34937407
Malaise 26.70 23.67 101 8237 185724 34762869
Blood pressure decreased 24.48 23.67 44 8294 51471 34897122
Chest pain 24.41 23.67 76 8262 126686 34821907
Dyspnoea 24.24 23.67 163 8175 376619 34571974
SARS-CoV-2 test positive 24.23 23.67 16 8322 5917 34942676
Anaemia 23.86 23.67 13 8325 233322 34715271

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
Chills 469.87 21.72 283 10468 159951 79573686
Globotriaosylceramide increased 189.91 21.72 24 10727 0 79733637
Drug specific antibody present 172.43 21.72 55 10696 6597 79727040
Renal transplant 160.30 21.72 42 10709 2505 79731132
Globotriaosylsphingosine increased 158.25 21.72 20 10731 0 79733637
Infusion related reaction 145.92 21.72 167 10584 230070 79503567
Product dose omission issue 103.44 21.72 146 10605 247391 79486246
Drug ineffective 99.74 21.72 14 10737 1080899 78652738
Antibody test negative 93.82 21.72 14 10737 33 79733604
Intentional dose omission 88.03 21.72 36 10715 8781 79724856
Off label use 87.86 21.72 10 10741 907205 78826432
Antibody test 83.62 21.72 11 10740 4 79733633
End stage renal disease 82.97 21.72 38 10713 12182 79721455
Urticaria 82.94 21.72 113 10638 185088 79548549
Flushing 80.76 21.72 78 10673 88190 79645447
Cerebrovascular accident 79.17 21.72 101 10650 155191 79578446
Drug specific antibody absent 77.70 21.72 15 10736 216 79733421
Pyrexia 75.34 21.72 231 10520 678478 79055159
Illness 75.20 21.72 57 10694 46454 79687183
Chronic kidney disease 73.17 21.72 65 10686 66089 79667548
Chest discomfort 66.00 21.72 87 10664 137957 79595680
Infusion site extravasation 64.15 21.72 30 10721 10078 79723559
Antibody test positive 63.85 21.72 21 10730 2771 79730866
Paraesthesia 60.62 21.72 95 10656 176228 79557409
SARS-CoV-2 test positive 59.94 21.72 30 10721 11686 79721951
Angiokeratoma 59.18 21.72 12 10739 225 79733412
COVID-19 58.48 21.72 88 10663 157586 79576051
Atrial fibrillation 56.43 21.72 98 10653 197788 79535849
Cardiac disorder 54.35 21.72 55 10696 65702 79667935
Haemodialysis 52.73 21.72 32 10719 18136 79715501
Feeling cold 50.43 21.72 37 10714 28692 79704945
Burning sensation 46.56 21.72 48 10703 58584 79675053
Throat tightness 44.65 21.72 34 10717 27873 79705764
Poor venous access 42.73 21.72 28 10723 18121 79715516
Toxicity to various agents 42.35 21.72 4 10747 421536 79312101
Drug interaction 41.55 21.72 4 10747 415179 79318458
Blood pressure decreased 40.44 21.72 58 10693 99408 79634229
Malaise 40.25 21.72 151 10600 489718 79243919
Body temperature increased 40.11 21.72 39 10712 44381 79689256
Vomiting 39.71 21.72 186 10565 665642 79067995
Chest pain 38.81 21.72 104 10647 282200 79451437
Ventricular hypertrophy 36.18 21.72 18 10733 6920 79726717
Peritoneal dialysis 34.74 21.72 10 10741 846 79732791
Neutralising antibodies positive 34.58 21.72 8 10743 283 79733354
Blood pressure increased 33.30 21.72 82 10669 211278 79522359
Nausea 32.45 21.72 230 10521 956966 78776671
Pain in extremity 32.11 21.72 115 10636 364423 79369214
Transient ischaemic attack 31.20 21.72 37 10714 52658 79680979
Infusion site reaction 30.61 21.72 13 10738 3480 79730157
Arrhythmia 29.84 21.72 39 10712 61233 79672404
Pain 29.19 21.72 178 10573 703624 79030013
Dyspnoea 27.88 21.72 204 10547 856821 78876816
Tremor 26.79 21.72 66 10685 170017 79563620
Proteinuria 26.50 21.72 27 10724 32475 79701162
Neutralising antibodies negative 26.36 21.72 4 10747 11 79733626
Dialysis 26.29 21.72 21 10730 18441 79715196
Blood immunoglobulin G increased 25.78 21.72 11 10740 2978 79730659
Mitral valve incompetence 25.64 21.72 25 10726 28540 79705097
Cerebral infarction 25.29 21.72 31 10720 45645 79687992
Acute kidney injury 25.08 21.72 20 10731 519384 79214253
Drug hypersensitivity 24.92 21.72 5 10746 298911 79434726
Heart rate increased 24.74 21.72 52 10699 120672 79612965
Headache 23.78 21.72 160 10591 653612 79080025
Lysozyme increased 23.74 21.72 3 10748 0 79733637
Cough 23.66 21.72 105 10646 366684 79366953
Inappropriate schedule of product administration 23.35 21.72 54 10697 133574 79600063
Left ventricular hypertrophy 23.30 21.72 16 10735 11175 79722462
Pruritus 23.25 21.72 110 10641 394538 79339099
Drug intolerance 22.91 21.72 4 10747 264115 79469522

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB04 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Enzymes
FDA CS M0000794 alpha-Glucosidases
FDA EPC N0000175822 Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme

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

DiseaseRelationSNOMED_IDDOID
Fabry's disease indication 16652001 DOID:14499




🐶 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
D03228 KEGG_DRUG
4021388 VUID
N0000148806 NUI
104138-64-9 SECONDARY_CAS_RN
4021388 VANDF
CHEMBL2108888 ChEMBL_ID
C459420 MESH_SUPPLEMENTAL_RECORD_UI
DB00103 DRUGBANK_ID
338817 RXNORM
17231 MMSL
46683 MMSL
d04866 MMSL
009873 NDDF
391653003 SNOMEDCT_US
424725004 SNOMEDCT_US
C1137427 UMLSCUI
8119 INN_ID
52918379 PUBCHEM_CID
RZD65TSM9U UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fabrazyme HUMAN PRESCRIPTION DRUG LABEL 1 58468-0040 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5 mg INTRAVENOUS BLA 28 sections
Fabrazyme HUMAN PRESCRIPTION DRUG LABEL 1 58468-0040 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5 mg INTRAVENOUS BLA 28 sections
Fabrazyme HUMAN PRESCRIPTION DRUG LABEL 1 58468-0041 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5 mg INTRAVENOUS BLA 28 sections
Fabrazyme HUMAN PRESCRIPTION DRUG LABEL 1 58468-0041 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5 mg INTRAVENOUS BLA 28 sections