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

Stem definition	Drug id	CAS RN
enzymes	5101	552858-79-4

Description:

Molecule

Description

Synonyms:

galsulfase
aryplase
naglazyme
galsulfase (genetical recombination)

a recombinant form of N-acetylgalactosamine-4-sulfatase

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Jan. 24, 2006	EMA
May 31, 2005	FDA	BIOMARIN

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
Cervical cord compression	160.15	48.48	20	694	201	63488107
Spinal cord compression	145.31	48.48	27	687	4121	63484187
Cervical spinal stenosis	114.14	48.48	20	694	2188	63486120
Corneal opacity	60.95	48.48	10	704	733	63487575
Pneumonia	56.72	48.48	44	670	456723	63031585

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
Spinal cord compression	148.97	46.43	29	538	3946	34952418
Cervical cord compression	102.74	46.43	14	553	195	34956169
Cervical spinal stenosis	58.53	46.43	11	556	1223	34955141

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
Cervical cord compression	185.73	38.74	25	1027	394	79742942
Spinal cord compression	158.69	38.74	32	1020	6345	79736991
Cervical spinal stenosis	142.55	38.74	25	1027	2334	79741002
Corneal opacity	49.60	38.74	9	1043	1011	79742325

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A16AB08	ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes
FDA CS	M0000794	alpha-Glucosidases
FDA EPC	N0000175823	Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

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

Disease	Relation	SNOMED_ID	DOID
Maroteaux-Lamy syndrome	indication	69463008

🐶 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
59UA429E5G	UNII
D06565	KEGG_DRUG
4024918	VANDF
C1615657	UMLSCUI
CHEMBL1201822	ChEMBL_ID
DB01279	DRUGBANK_ID
8567	INN_ID
C508864	MESH_SUPPLEMENTAL_RECORD_UI
578033	RXNORM
20500	MMSL
71096	MMSL
d05634	MMSL
010814	NDDF
419797001	SNOMEDCT_US
420241006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
NAGLAZYME	HUMAN PRESCRIPTION DRUG LABEL	1	68135-020	SOLUTION	5 mg	INTRAVENOUS	BLA	23 sections
NAGLAZYME	HUMAN PRESCRIPTION DRUG LABEL	1	68135-020	SOLUTION	5 mg	INTRAVENOUS	BLA	23 sections