All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
enzymes	5030	420784-05-0

Description:

Molecule	Description
Synonyms: alglucosidase alfa alglucosidase alfa (genetical recombination) myozyme rhGAA lumizyme	Defects in the gene for this protein cause glycogen storage disease II, also known as Pompe disease, RefSeq NM_000152 Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
0.10	g	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 29, 2006	EMA
April 28, 2006	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
Drug specific antibody present	105.25	31.50	25	2034	4234	63482729
Respiratory failure	76.26	31.50	45	2014	101813	63385150
Inappropriate schedule of product administration	67.67	31.50	42	2017	103923	63383040
Blood immunoglobulin G increased	53.51	31.50	13	2046	2414	63484549
Drug specific antibody absent	47.11	31.50	7	2052	88	63486875
Disease progression	40.98	31.50	33	2026	122725	63364238
Pyrexia	39.31	31.50	61	1998	470417	63016546
Antibody test positive	37.47	31.50	10	2049	2697	63484266
Respiratory disorder	36.53	31.50	20	2039	39062	63447901
Respiratory distress	33.46	31.50	18	2041	33933	63453030
Oxygen saturation decreased	32.08	31.50	25	2034	88560	63398403

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
Drug specific antibody present	102.35	35.81	26	1988	3259	34951658
Inappropriate schedule of product administration	67.76	35.81	43	1971	62253	34892664
Respiratory failure	52.43	35.81	46	1968	108526	34846391
Antibody test positive	51.44	35.81	11	2003	647	34954270
Urticaria	48.51	35.81	35	1979	62342	34892575
Pyrexia	44.47	35.81	73	1941	332940	34621977
Drug specific antibody absent	43.32	35.81	7	2007	85	34954832
Heart rate increased	40.63	35.81	28	1986	46315	34908602
Respiratory distress	39.65	35.81	25	1989	35640	34919277

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
Drug specific antibody present	215.32	32.54	52	3644	6600	79734092
Inappropriate schedule of product administration	118.89	32.54	75	3621	133553	79607139
Respiratory failure	109.53	32.54	80	3616	180831	79559861
Drug specific antibody absent	93.72	32.54	15	3681	216	79740476
Urinary hexose tetrasaccharide increased	71.84	32.54	8	3688	0	79740692
Antibody test positive	71.01	32.54	18	3678	2774	79737918
Pyrexia	70.49	32.54	118	3578	678591	79062101
Respiratory distress	67.97	32.54	39	3657	58300	79682392
Urticaria	65.61	32.54	60	3636	185141	79555551
Disease progression	61.96	32.54	58	3638	184304	79556388
Respiratory disorder	54.96	32.54	31	3665	44825	79695867
Hypotonia	54.44	32.54	21	3675	12849	79727843
Oxygen saturation decreased	52.00	32.54	45	3651	129002	79611690
Blood immunoglobulin G increased	50.78	32.54	14	3682	2975	79737717
Pneumonia	41.51	32.54	93	3603	660153	79080539
Respiratory tract infection	37.45	32.54	25	3671	48664	79692028
Product dose omission issue	36.77	32.54	51	3645	247486	79493206
Muscular weakness	36.53	32.54	41	3655	160688	79580004
Product preparation issue	35.40	32.54	9	3687	1401	79739291
Glycogen storage disease type II	33.15	32.54	4	3692	4	79740688

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A16AB07	ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes
FDA CS	M0000794	alpha-Glucosidases
FDA EPC	N0000175821	Hydrolytic Lysosomal Glycogen-specific Enzyme

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

Disease	Relation	SNOMED_ID	DOID
Lysosomal alpha-1,4-glucosidase deficiency - infantile onset	indication	237968007

🐶 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
DTI67O9503	UNII
4025286	VUID
N0000171827	NUI
4025286	VANDF
C1695579	UMLSCUI
CHEMBL1201824	ChEMBL_ID
D03207	KEGG_DRUG
DB01272	DRUGBANK_ID
8475	INN_ID
C509951	MESH_SUPPLEMENTAL_RECORD_UI
7561	IUPHAR_LIGAND_ID
629565	RXNORM
173607	MMSL
21354	MMSL
81670	MMSL
d05787	MMSL
011335	NDDF
703393008	SNOMEDCT_US
714623006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Lumizyme	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0160	INJECTION, POWDER, FOR SOLUTION	5 mg	INTRAVENOUS	BLA	27 sections
Lumizyme	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0160	INJECTION, POWDER, FOR SOLUTION	5 mg	INTRAVENOUS	BLA	27 sections
Lumizyme	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0160	INJECTION, POWDER, FOR SOLUTION	5 mg	INTRAVENOUS	BLA	27 sections