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

Stem definition	Drug id	CAS RN
enzymes	4989	884604-91-5

Description:

Molecule

Description

Synonyms:

velaglucerase alfa
vpriv
EC 3.2.1.45

produced by gene activation technology in a human fibroblast cell line and has the same amino acid sequence as the naturally occurring human enzyme glucocerebrosidase

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
Aug. 26, 2010	EMA
Feb. 26, 2010	FDA	SHIRE HUMAN GENETIC

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
Inappropriate schedule of product administration	82.99	32.40	38	984	103927	63384073
Exposure during pregnancy	63.03	32.40	36	986	155511	63332489
No adverse event	42.14	32.40	18	1004	41387	63446613
Cholangiocarcinoma	40.30	32.40	8	1014	1186	63486814
Infusion related reaction	39.27	32.40	32	990	245489	63242511
Abortion spontaneous	36.73	32.40	17	1005	47178	63440822
Poor venous access	35.35	32.40	12	1010	14773	63473227

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
Inappropriate schedule of product administration	56.74	40.49	28	787	62268	34893848
Infusion related reaction	54.80	40.49	26	789	53031	34903085
COVID-19	53.74	40.49	29	786	77521	34878595
Bone pain	51.49	40.49	19	796	20667	34935449
Product dose omission issue	49.38	40.49	32	783	119679	34836437
Weight fluctuation	43.38	40.49	12	803	5173	34950943

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
Inappropriate schedule of product administration	108.35	31.03	53	1556	133575	79609204
COVID-19	67.44	31.03	41	1568	157633	79585146
Product dose omission issue	61.66	31.03	46	1563	247491	79495288
Poor venous access	52.57	31.03	18	1591	18131	79724648
Weight fluctuation	51.81	31.03	16	1593	11659	79731120
Bone pain	50.74	31.03	24	1585	55718	79687061
Infusion related reaction	49.00	31.03	39	1570	230198	79512581

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A16AB10	ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes
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
Chronic non-neuropathic Gaucher's disease	indication	62201009

🐶 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
23HYE36B0I	UNII
D09029	KEGG_DRUG
4029768	VUID
N0000180860	NUI
4029768	VANDF
C2919267	UMLSCUI
CHEMBL1201865	ChEMBL_ID
DB06720	DRUGBANK_ID
8925	INN_ID
7464	IUPHAR_LIGAND_ID
901805	RXNORM
171696	MMSL
27053	MMSL
d07588	MMSL
013387	NDDF
444773003	SNOMEDCT_US
445499001	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
VPRIV	HUMAN PRESCRIPTION DRUG LABEL	1	54092-701	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	2.50 mg	INTRAVENOUS	BLA	24 sections
VPRIV	HUMAN PRESCRIPTION DRUG LABEL	1	54092-701	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	2.50 mg	INTRAVENOUS	BLA	24 sections