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

Stem definition	Drug id	CAS RN
enzymes	5018	None

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
5	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
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 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
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
Globotriaosylceramide increased	70.34	24.79	8	3545	0	63485469
Globotriaosylsphingosine 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 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
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 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
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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