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

Stem definition	Drug id	CAS RN
enzymes	4997	210589-09-6

Description:

Molecule	Description
Synonyms: laronidase aldurazyme laronidase (genetical recombination)	Laronidase is a polymorphic variant of the human enzyme alpha‑l‑iduronidase that is produced by recombinant DNA technology which catalyzes the hydrolysis of terminal alpha-l-iduronic acid residues of dermatan sulfate and heparan sulfate. Reduced or absent alpha-L-iduronidase activity results in the accumulation of the glycosaminoglycans (GAG) substrates, dermatan sulfate and heparan sulfate, throughout the body and leads to widespread cellular, tissue, and organ dysfunction. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

laronidase
aldurazyme
laronidase (genetical recombination)

Laronidase is a polymorphic variant of the human enzyme alpha‑l‑iduronidase that is produced by recombinant DNA technology which catalyzes the hydrolysis of terminal alpha-l-iduronic acid residues of dermatan sulfate and heparan sulfate. Reduced or absent alpha-L-iduronidase activity results in the accumulation of the glycosaminoglycans (GAG) substrates, dermatan sulfate and heparan sulfate, throughout the body and leads to widespread cellular, tissue, and organ dysfunction.

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

Drug dosage:

Dose	Unit	Route
1	TU	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 10, 2003	EMA
April 30, 2003	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
Stem cell transplant	44.46	28.47	10	1504	1812	63485696
Pyrexia	44.30	28.47	55	1459	470423	63017085
Urinary glycosaminoglycans increased	38.58	28.47	4	1510	0	63487508
Cyanosis	36.11	28.47	14	1500	16921	63470587
Hydrocephalus	33.87	28.47	10	1504	5290	63482218
Respiratory failure	31.27	28.47	23	1491	101835	63385673
Pneumonia	30.12	28.47	45	1469	456722	63030786
Respiratory distress	29.67	28.47	15	1499	33936	63453572

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
Urticaria	62.32	40.67	35	1281	62342	34893273

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
Respiratory distress	62.41	31.15	34	2885	58305	79683164
Cyanosis	61.86	31.15	26	2893	25156	79716313
Pyrexia	60.88	31.15	97	2822	678612	79062857
Respiratory failure	56.00	31.15	49	2870	180862	79560607
Stem cell transplant	55.77	31.15	15	2904	3689	79737780
Bone marrow transplant	53.15	31.15	12	2907	1436	79740033
Urticaria	53.03	31.15	48	2871	185153	79556316
Hydrocephalus	50.60	31.15	17	2902	8883	79732586
Urinary glycosaminoglycans increased	46.08	31.15	5	2914	0	79741469
Poor venous access	45.44	31.15	19	2900	18130	79723339
Oxygen saturation decreased	44.06	31.15	37	2882	129010	79612459
Corneal transplant	37.21	31.15	7	2912	340	79741129
Infusion related reaction	35.71	31.15	43	2876	230194	79511275
Spinal cord compression	35.54	31.15	12	2907	6365	79735104
Pneumonia	32.28	31.15	73	2846	660173	79081296
Tachycardia	32.24	31.15	36	2883	177732	79563737
Pallor	32.11	31.15	21	2898	50041	79691428
Graft versus host disease	31.90	31.15	14	2905	15012	79726457

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A16AB05	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
Mucopolysaccharidosis, MPS-I	indication	75610003	DOID:12802

🐶 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
D04670	KEGG_DRUG
4021389	VUID
N0000148807	NUI
4021389	VANDF
CHEMBL1201595	ChEMBL_ID
DB00090	DRUGBANK_ID
392509	RXNORM
17247	MMSL
46700	MMSL
d04867	MMSL
009982	NDDF
398789008	SNOMEDCT_US
409264006	SNOMEDCT_US
C1302054	UMLSCUI
8015	INN_ID
WP58SVM6R4	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ALDURAZYME	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0070	INJECTION, SOLUTION, CONCENTRATE	2.90 mg	INTRAVENOUS	BLA	25 sections
ALDURAZYME	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0070	INJECTION, SOLUTION, CONCENTRATE	2.90 mg	INTRAVENOUS	BLA	25 sections