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

Stem definitionDrug idCAS RN
enzymes 5030 420784-05-0

Description:

MoleculeDescription

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:

DoseUnitRoute
0.10 g P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 29, 2006 EMA
April 28, 2006 FDA GENZYME

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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