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

Stem definition	Drug id	CAS RN
enzymes	4932	154248-97-2

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
300	U	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Nov. 17, 1997	EMA	Genzyme Europe B.V.
May 23, 1994	FDA	GENZYME

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
Exposure during pregnancy	193.94	22.31	114	3296	155433	63330179
Chitotriosidase increased	120.16	22.31	14	3396	4	63485608
Abortion spontaneous	98.98	22.31	49	3361	47146	63438466
Osteonecrosis	81.27	22.31	35	3375	24495	63461117
Bone pain	81.05	22.31	45	3365	54596	63431016
Bone infarction	65.86	22.31	12	3398	329	63485283
Splenomegaly	57.94	22.31	22	3388	11135	63474477
Seizure	54.82	22.31	50	3360	132584	63353028
Blood acid phosphatase increased	44.16	22.31	5	3405	0	63485612
Surgical procedure repeated	36.05	22.31	7	3403	272	63485340
Disease progression	33.55	22.31	37	3373	122721	63362891
Product dose omission issue	33.17	22.31	51	3359	234262	63251350
Pregnancy	33.03	22.31	22	3388	36814	63448798
Epilepsy	31.34	22.31	19	3391	27046	63458566
Bone disorder	30.04	22.31	17	3393	21309	63464303
Respiratory failure	28.34	22.31	31	3379	101827	63383785
Poor venous access	26.99	22.31	14	3396	14771	63470841
Spleen disorder	26.79	22.31	7	3403	1046	63484566
Drug ineffective	25.89	22.31	12	3398	1044753	62440859
Angiotensin converting enzyme increased	23.25	22.31	4	3406	78	63485534
Cyanosis	22.51	22.31	13	3397	16922	63468690

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
Osteonecrosis	69.77	25.81	29	2323	14861	34939718
Chitotriosidase increased	47.01	25.81	6	2346	7	34954572
Seizure	43.89	25.81	44	2308	104813	34849766
Epilepsy	42.18	25.81	23	2329	21472	34933107
Bone pain	40.21	25.81	22	2330	20664	34933915
Status epilepticus	34.86	25.81	17	2335	12597	34941982
Disease progression	32.31	25.81	38	2314	108039	34846540
Respiratory failure	32.17	25.81	38	2314	108534	34846045
Product dose omission issue	27.65	25.81	37	2315	119674	34834905
Splenomegaly	26.43	25.81	15	2337	15102	34939477

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
Exposure during pregnancy	143.20	21.69	87	5207	101045	79638049
Chitotriosidase increased	128.99	21.69	16	5278	12	79739082
Osteonecrosis	124.59	21.69	54	5240	31041	79708053
Bone pain	92.01	21.69	53	5241	55689	79683405
Abortion spontaneous	85.79	21.69	41	5253	29466	79709628
Seizure	83.11	21.69	81	5213	188753	79550341
Bone infarction	64.59	21.69	13	5281	490	79738604
Product dose omission issue	61.85	21.69	79	5215	247458	79491636
Blood acid phosphatase increased	60.35	21.69	7	5287	0	79739094
Splenomegaly	51.81	21.69	26	5268	20728	79718366
Status epilepticus	44.48	21.69	25	5269	25016	79714078
Respiratory failure	43.97	21.69	57	5237	180854	79558240
Epilepsy	42.49	21.69	29	5265	40831	79698263
Spleen disorder	38.91	21.69	11	5283	1783	79737311
Disease progression	38.56	21.69	54	5240	184308	79554786
Bone disorder	36.45	21.69	20	5274	19093	79720001
Off label use	36.34	21.69	8	5286	907207	78831887
Femur fracture	34.53	21.69	25	5269	38627	79700467
Pneumonia	32.71	21.69	107	5187	660139	79078955
Surgical procedure repeated	32.54	21.69	8	5286	756	79738338
Parkinson's disease	30.68	21.69	9	5285	1662	79737432
Pregnancy	30.17	21.69	20	5274	26831	79712263
Poor venous access	29.23	21.69	17	5277	18132	79720962
Drug ineffective	27.78	21.69	19	5275	1080894	78658200
Cyanosis	26.47	21.69	18	5276	25164	79713930
Angiotensin converting enzyme increased	25.57	21.69	5	5289	162	79738932
Myoclonic epilepsy	25.05	21.69	8	5286	1962	79737132
Device related infection	23.62	21.69	19	5275	34275	79704819
Laryngospasm	22.99	21.69	9	5285	3988	79735106

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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

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

Disease	Relation	SNOMED_ID	DOID
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:

ID	Source
D03020	KEGG_DRUG
4020874	VANDF
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
D005962	MESH_DESCRIPTOR_UI
7324	INN_ID
Q6U6J48BWY	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cerezyme	HUMAN PRESCRIPTION DRUG LABEL	1	58468-4663	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	40 U	INTRAVENOUS	BLA	25 sections
Cerezyme	HUMAN PRESCRIPTION DRUG LABEL	1	58468-4663	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	40 U	INTRAVENOUS	BLA	25 sections
Cerezyme	HUMAN PRESCRIPTION DRUG LABEL	1	58468-4663	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	40 U	INTRAVENOUS	BLA	25 sections