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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

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

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
Globotriaosylsphingosine increased 567.37 26.57 65 5364 0 90623018
Globotriaosylceramide increased 226.86 26.57 26 5403 0 90623018
Illness 160.01 26.57 84 5345 81885 90541133
Weight decreased 85.19 26.57 109 5320 379801 90243217
Antibody test 81.93 26.57 10 5419 7 90623011
COVID-19 79.78 26.57 72 5357 168771 90454247
Poor venous access 78.47 26.57 33 5396 19494 90603524
Infusion site extravasation 75.64 26.57 27 5402 10301 90612717
Intentional dose omission 74.64 26.57 31 5398 17752 90605266
Weight increased 66.86 26.57 102 5327 417825 90205193
Burning sensation 62.84 26.57 42 5387 63410 90559608
Product dose omission issue 62.64 26.57 82 5347 291605 90331413
Cardiac disorder 57.17 26.57 38 5391 56834 90566184
Inappropriate schedule of product administration 50.24 26.57 53 5376 149880 90473138
Malaise 50.12 26.57 109 5320 585877 90037141
SARS-CoV-2 test positive 48.73 26.57 20 5409 11108 90611910
Antibody test negative 47.45 26.57 7 5422 42 90622976
Drug ineffective 46.29 26.57 13 5416 1384285 89238733
Cerebrovascular accident 41.96 26.57 44 5385 123489 90499529
Exposure during pregnancy 40.60 26.57 60 5369 238350 90384668
Temperature intolerance 37.48 26.57 17 5412 12013 90611005
Incorrect dose administered 35.92 26.57 33 5396 78897 90544121
Drug specific antibody present 35.09 26.57 13 5416 5501 90617517
Drug specific antibody absent 34.42 26.57 6 5423 113 90622905
Cough 34.18 26.57 71 5358 368891 90254127
Palpitations 28.59 26.57 38 5391 136690 90486328
Chest discomfort 28.23 26.57 38 5391 138327 90484691
Vein rupture 27.20 26.57 8 5421 1653 90621365
Pyrexia 27.18 26.57 94 5335 660391 89962627
Chest pain 26.69 26.57 59 5370 319586 90303432

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
Drug specific antibody present 600.06 23.87 149 10388 3857 42606941
Chills 543.81 23.87 319 10218 93747 42517051
Globotriaosylsphingosine increased 518.93 23.87 71 10466 0 42610798
Globotriaosylceramide increased 350.77 23.87 48 10489 0 42610798
Neutralising antibodies positive 267.34 23.87 43 10494 85 42610713
Infusion related reaction 263.42 23.87 172 10365 60634 42550164
Renal transplant 203.37 23.87 57 10480 2368 42608430
Illness 131.50 23.87 80 10457 24850 42585948
Antibody test positive 87.96 23.87 23 10514 731 42610067
End stage renal disease 86.93 23.87 53 10484 16505 42594293
Off label use 85.76 23.87 26 10511 638309 41972489
Drug ineffective 84.06 23.87 26 10511 630171 41980627
Flushing 83.78 23.87 71 10466 36957 42573841
Feeling cold 82.48 23.87 47 10490 12926 42597872
Weight increased 77.10 23.87 113 10424 107870 42502928
Urticaria 76.74 23.87 93 10444 73943 42536855
Pyrexia 75.71 23.87 241 10296 393801 42216997
Chronic kidney disease 74.49 23.87 74 10463 47167 42563631
Cerebrovascular accident 68.36 23.87 101 10436 97059 42513739
Angiokeratoma 63.29 23.87 11 10526 41 42610757
Chest discomfort 62.81 23.87 78 10459 63538 42547260
Pain in extremity 60.37 23.87 122 10415 150482 42460316
Pain 59.50 23.87 163 10374 244685 42366113
Burning sensation 57.42 23.87 45 10492 20968 42589830
Paraesthesia 56.96 23.87 80 10457 73379 42537419
Poor venous access 53.55 23.87 29 10508 7223 42603575
Vomiting 53.47 23.87 175 10362 289548 42321250
Malaise 52.26 23.87 142 10395 212014 42398784
Throat tightness 51.08 23.87 31 10506 9568 42601230
Weight decreased 51.03 23.87 139 10398 207809 42402989
Drug interaction 50.98 23.87 4 10533 266995 42343803
Nausea 49.31 23.87 211 10326 396588 42214210
Infusion site extravasation 49.26 23.87 25 10512 5456 42605342
Acute kidney injury 49.08 23.87 15 10522 367322 42243476
Body temperature increased 48.01 23.87 40 10497 20318 42590480
Drug specific antibody absent 45.56 23.87 9 10528 76 42610722
Cardiac disorder 45.11 23.87 58 10479 48874 42561924
Haemodialysis 44.23 23.87 29 10508 10231 42600567
Antibody test negative 42.23 23.87 7 10530 18 42610780
Toxicity to various agents 42.18 23.87 4 10533 229132 42381666
Tremor 41.77 23.87 81 10456 96848 42513950
Headache 40.04 23.87 140 10397 239229 42371569
Infusion site reaction 35.28 23.87 13 10524 1303 42609495
Atrial fibrillation 33.87 23.87 93 10444 139500 42471298
Feeling hot 33.73 23.87 35 10502 23447 42587351
Blood immunoglobulin G increased 33.28 23.87 12 10525 1130 42609668
Blood pressure increased 32.12 23.87 75 10462 101853 42508945
Chest pain 31.92 23.87 91 10446 139439 42471359
Anaemia 31.48 23.87 15 10522 280263 42330535
Dialysis 31.30 23.87 25 10512 11961 42598837
Temperature intolerance 29.49 23.87 17 10520 4771 42606027
Transient ischaemic attack 28.01 23.87 38 10499 33701 42577097
Peritoneal dialysis 27.94 23.87 9 10528 602 42610196
Inappropriate schedule of product administration 27.45 23.87 68 10469 95834 42514964
Antibody test 26.99 23.87 4 10533 3 42610795
Dyspnoea 26.86 23.87 194 10343 442427 42168371
Death 25.27 23.87 49 10488 471136 42139662
Thrombocytopenia 24.94 23.87 8 10529 190271 42420527
Heart rate increased 24.76 23.87 46 10491 53209 42557589
Cough 24.58 23.87 98 10439 178005 42432793
Blood pressure decreased 24.20 23.87 48 10489 58284 42552514
Intentional dose omission 24.01 23.87 19 10518 8967 42601831

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
Globotriaosylsphingosine increased 1072.86 22.16 135 14323 0 110574841
Drug specific antibody present 633.39 22.16 159 14299 8275 110566566
Globotriaosylceramide increased 548.20 22.16 69 14389 0 110574841
Chills 512.03 22.16 315 14143 190265 110384576
Neutralising antibodies positive 247.04 22.16 43 14415 345 110574496
Illness 243.73 22.16 145 14313 82026 110492815
Renal transplant 198.68 22.16 52 14406 3186 110571655
Drug ineffective 109.31 22.16 32 14426 1520508 109054333
Infusion related reaction 105.50 22.16 183 14275 380979 110193862
Weight decreased 104.76 22.16 205 14253 467852 110106989
Off label use 100.00 22.16 36 14422 1500149 109074692
Burning sensation 97.08 22.16 77 14381 69135 110505706
Cerebrovascular accident 97.04 22.16 119 14339 181165 110393676
Poor venous access 93.39 22.16 51 14407 24471 110550370
Infusion site extravasation 92.35 22.16 40 14418 11594 110563247
Weight increased 91.68 22.16 182 14276 419462 110155379
Pyrexia 91.55 22.16 291 14167 897974 109676867
Antibody test negative 90.83 22.16 14 14444 46 110574795
Cardiac disorder 90.51 22.16 77 14381 76203 110498638
Antibody test 83.96 22.16 11 14447 4 110574837
Chest discomfort 81.74 22.16 107 14351 173741 110401100
Intentional dose omission 79.91 22.16 43 14415 20037 110554804
Inappropriate schedule of product administration 78.69 22.16 114 14344 203523 110371318
Flushing 78.62 22.16 82 14376 104654 110470187
Chronic kidney disease 78.46 22.16 71 14387 76220 110498621
Drug specific antibody absent 77.28 22.16 15 14443 230 110574611
Angiokeratoma 72.86 22.16 14 14444 203 110574638
Atrial fibrillation 72.43 22.16 117 14341 229525 110345316
Antibody test positive 70.17 22.16 23 14435 3097 110571744
COVID-19 66.83 22.16 117 14341 244943 110329898
End stage renal disease 66.48 22.16 39 14419 21434 110553407
Malaise 65.87 22.16 215 14243 671604 109903237
Product dose omission issue 60.15 22.16 131 14327 321651 110253190
Feeling cold 59.10 22.16 43 14415 33944 110540897
Haemodialysis 57.01 22.16 33 14425 17686 110557155
SARS-CoV-2 test positive 55.71 22.16 32 14426 16903 110557938
Throat tightness 55.14 22.16 41 14417 33448 110541393
Paraesthesia 54.45 22.16 115 14343 276406 110298435
Urticaria 50.92 22.16 122 14336 318735 110256106
Drug interaction 50.35 22.16 4 14454 500179 110074662
Temperature intolerance 50.32 22.16 28 14430 13922 110560919
Chest pain 49.70 22.16 134 14324 376241 110198600
Toxicity to various agents 47.93 22.16 4 14454 480551 110094290
Blood pressure decreased 45.24 22.16 65 14393 115026 110459815
Pain in extremity 43.32 22.16 151 14307 486967 110087874
Blood pressure increased 42.47 22.16 100 14358 258273 110316568
Transient ischaemic attack 39.13 22.16 45 14413 63937 110510904
Tremor 38.50 22.16 83 14375 202149 110372692
Cough 38.37 22.16 140 14318 461501 110113340
Body temperature increased 37.78 22.16 41 14417 54672 110520169
Proteinuria 36.78 22.16 35 14423 39983 110534858
Ventricular hypertrophy 36.44 22.16 18 14440 7027 110567814
Arrhythmia 36.09 22.16 45 14413 69530 110505311
Nausea 36.04 22.16 280 14178 1235410 109339431
Complement factor C3 increased 35.82 22.16 8 14450 249 110574592
Peritoneal dialysis 34.50 22.16 10 14448 894 110573947
Vomiting 34.50 22.16 220 14238 910455 109664386
Pain 33.93 22.16 227 14231 954728 109620113
Dyspnoea 33.46 22.16 253 14205 1106619 109468222
Heart rate increased 33.26 22.16 64 14394 143770 110431071
Incorrect dose administered 32.89 22.16 53 14405 103588 110471253
Dialysis 32.25 22.16 24 14434 19595 110555246
Anhidrosis 32.10 22.16 8 14450 402 110574439
Drug intolerance 32.03 22.16 7 14451 406505 110168336
Globotriaosylceramide 31.77 22.16 4 14454 0 110574841
Cerebral infarction 30.93 22.16 36 14422 51802 110523039
Cardiac hypertrophy 30.69 22.16 11 14447 1936 110572905
Acute kidney injury 30.66 22.16 23 14435 635407 109939434
Heart rate decreased 30 22.16 45 14413 82711 110492130
Cardiac pacemaker insertion 29.36 22.16 15 14443 6286 110568555
Mitral valve incompetence 28.47 22.16 28 14430 33301 110541540
Left ventricular hypertrophy 28.26 22.16 19 14439 13225 110561616
Condition aggravated 27.46 22.16 177 14281 734659 109840182
Alopecia 27.31 22.16 7 14451 364746 110210095
Palpitations 26.55 22.16 62 14396 159150 110415691
Neutralising antibodies negative 26.49 22.16 4 14454 11 110574830
Headache 26.22 22.16 201 14257 882176 109692665
Joint swelling 25.55 22.16 13 14445 442832 110132009
Hypoacusis 25.40 22.16 27 14431 35164 110539677
Ventricular tachycardia 25.38 22.16 32 14426 49977 110524864
Lysozyme increased 23.83 22.16 3 14455 0 110574841
Drug hypersensitivity 23.80 22.16 15 14443 454075 110120766
Thrombocytopenia 23.74 22.16 8 14450 348877 110225964
Anaemia 23.67 22.16 22 14436 547064 110027777
Throat irritation 23.65 22.16 32 14426 53520 110521321
Blood immunoglobulin G increased 23.55 22.16 11 14447 3797 110571044
Incorrect drug administration rate 22.48 22.16 12 14446 5496 110569345
Hypertrophic cardiomyopathy 22.27 22.16 10 14448 3153 110571688

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

Related Drugs by ATC class:

A16AB Enzymes 24 drugs
agalsidase alfaalglucerasealglucosidase alfaasfotase alfaavalglucosidase alfacerliponase alfacipaglucosidase alfaeladocagene exuparvovecelosulfase alfagalsulfaseidursulfaseidursulfase beta show all 24 →

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
CHEBI:753807 CHEBI
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
RZD65TSM9U UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fabrazyme HUMAN PRESCRIPTION DRUG LABEL 1 58468-0040 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5 mg INTRAVENOUS BLA 29 sections
Fabrazyme HUMAN PRESCRIPTION DRUG LABEL 1 58468-0041 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5 mg INTRAVENOUS BLA 29 sections