alglucosidase alfa 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

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

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 208.47 30.46 45 2634 5469 90620299
Inappropriate schedule of product administration 183.76 30.46 89 2590 149844 90475924
Respiratory failure 84.20 30.46 49 2630 118369 90507399
Blood immunoglobulin G increased 52.08 30.46 13 2666 2959 90622809
Pyrexia 50.21 30.46 78 2601 660407 89965361
Disease progression 40.60 30.46 35 2644 156580 90469188
Drug specific antibody absent 38.66 30.46 6 2673 113 90625655
Oxygen saturation decreased 38.43 30.46 29 2650 107454 90518314
Respiratory distress 38.32 30.46 20 2659 38926 90586842
Antibody test positive 37.40 30.46 10 2669 2979 90622789
Respiratory disorder 36.16 30.46 23 2656 64793 90560975
Urinary hexose tetrasaccharide increased 34.05 30.46 4 2675 6 90625762
Poor venous access 31.25 30.46 14 2665 19513 90606255
Pneumonia 31.00 30.46 62 2617 637997 89987771
Device related infection 30.49 30.46 15 2664 25771 90599997

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 191.86 34.17 45 2469 3961 42614860
Inappropriate schedule of product administration 152.26 34.17 85 2429 95817 42523004
Respiratory failure 52.39 34.17 50 2464 128082 42490739
Pyrexia 51.90 34.17 87 2427 393955 42224866
Antibody test positive 49.69 34.17 11 2503 743 42618078
Oxygen saturation decreased 48.82 34.17 36 2478 64651 42554170
Urticaria 48.81 34.17 38 2476 73998 42544823
Respiratory distress 45.08 34.17 29 2485 41791 42577030
Respiratory disorder 44.43 34.17 23 2491 22062 42596759
Drug specific antibody absent 43.71 34.17 7 2507 78 42618743
Heart rate increased 43.27 34.17 31 2483 53224 42565597
Urinary hexose tetrasaccharide increased 40.23 34.17 5 2509 5 42618816
Hypotonia 34.91 34.17 15 2499 9484 42609337

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 387.43 31.14 86 4561 8348 110576304
Inappropriate schedule of product administration 293.22 31.14 151 4496 203486 110381166
Respiratory failure 121.90 31.14 88 4559 215244 110369408
Urinary hexose tetrasaccharide increased 93.29 31.14 11 4636 9 110584643
Drug specific antibody absent 87.04 31.14 14 4633 231 110584421
Pyrexia 86.43 31.14 143 4504 898122 109686530
Respiratory distress 78.82 31.14 44 4603 68830 110515822
Oxygen saturation decreased 72.79 31.14 57 4590 156925 110427727
Antibody test positive 70.76 31.14 18 4629 3102 110581550
Hypotonia 59.33 31.14 23 4624 15722 110568930
Respiratory disorder 59.09 31.14 37 4610 71345 110513307
Disease progression 58.31 31.14 61 4586 243973 110340679
Pneumonia 51.12 31.14 113 4534 876601 109708051
Urticaria 49.76 31.14 64 4583 318793 110265859
Blood immunoglobulin G increased 48.78 31.14 14 4633 3794 110580858
Illness 47.32 31.14 34 4613 82137 110502515
Poor venous access 46.42 31.14 22 4625 24500 110560152
Central venous catheterisation 44.23 31.14 13 4634 3829 110580823
Respiratory tract infection 42.07 31.14 30 4617 71587 110513065
Cyanosis 39.55 31.14 21 4626 29720 110554932
Heart rate increased 38.02 31.14 38 4609 143796 110440856
Product preparation issue 34.63 31.14 10 4637 2769 110581883
Muscular weakness 34.29 31.14 47 4600 248421 110336231
Incorrect dose administered 34.27 31.14 31 4616 103610 110481042
Device related infection 33.99 31.14 21 4626 39498 110545154
Infusion site extravasation 33.48 31.14 14 4633 11620 110573032
Dyspnoea 32.52 31.14 111 4536 1106761 109477891

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

Related Drugs by ATC class:

A16AB Enzymes 24 drugs
agalsidase alfaagalsidase betaalgluceraseasfotase alfaavalglucosidase alfacerliponase alfacipaglucosidase alfaeladocagene exuparvovecelosulfase alfagalsulfaseidursulfaseidursulfase beta show all 24 →

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
CHEBI:749600 CHEBI
CHEMBL1201824 ChEMBL_ID
D03207 KEGG_DRUG
DB01272 DRUGBANK_ID
8475 INN_ID
C000731976 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 29 sections