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

Stem definitionDrug idCAS RN
enzymes 5049 1174277-80-5

Description:

MoleculeDescription

Synonyms:

  • asfotase alpha
  • asfotase alfa
  • ALXN1215
  • ENB-0040
  • alkaline phosphatase
  • strensiq
  • ALXN-1215
An enzyme that catalyzes the conversion of an orthophosphoric monoester and water to an alcohol and orthophosphate. EC 3.1.3.1.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Aug. 28, 2015 EMA Alexion Europe SAS
Oct. 23, 2015 FDA ALEXION PHARM

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
Vitamin B6 decreased 342.67 24.97 40 4595 15 90623797
Injection site pain 251.25 24.97 138 4497 173561 90450251
Injection site reaction 236.19 24.97 108 4527 91972 90531840
Injection site erythema 160.92 24.97 85 4550 98417 90525395
Blood alkaline phosphatase decreased 130.54 24.97 27 4608 1526 90622286
Injection site atrophy 127.80 24.97 24 4611 820 90622992
Vitamin B6 increased 124.68 24.97 17 4618 63 90623749
Bone pain 102.55 24.97 54 4581 61929 90561883
Injection site discolouration 90.70 24.97 29 4606 9291 90614521
Arthralgia 86.08 24.97 147 4488 778375 89845437
Myalgia 77.15 24.97 67 4568 175058 90448754
Injection site swelling 73.87 24.97 43 4592 59796 90564016
Injection site bruising 71.02 24.97 40 4595 52267 90571545
Nephrocalcinosis 67.18 24.97 15 4620 1217 90622595
Nephrolithiasis 59.85 24.97 35 4600 49050 90574762
Injection site hypertrophy 58.09 24.97 9 4626 93 90623719
Injection site mass 56.74 24.97 26 4609 22064 90601748
Rickets 52.54 24.97 8 4627 73 90623739
Calcinosis 50.85 24.97 14 4621 2681 90621131
Fatigue 49.84 24.97 150 4485 1153873 89469939
Tooth loss 47.75 24.97 17 4618 7537 90616275
Pain in extremity 46.80 24.97 83 4552 450446 90173366
Injection site pruritus 42.11 24.97 29 4606 53805 90570007
Vitamin D decreased 40.14 24.97 17 4618 11962 90611850
Back pain 38.94 24.97 63 4572 317112 90306700
Pain 36.92 24.97 123 4512 996218 89627594
Injection site urticaria 36.46 24.97 18 4617 17993 90605819
Hypermobility syndrome 33.37 24.97 8 4627 886 90622926
Craniosynostosis 33.06 24.97 6 4629 169 90623643
Fracture 33.00 24.97 18 4617 22058 90601754
Injection site nodule 31.84 24.97 11 4624 4462 90619350
Injection site warmth 31.04 24.97 16 4619 17499 90606313
Loose tooth 29.76 24.97 10 4625 3733 90620079
Muscular weakness 29.44 24.97 44 4591 206622 90417190
Blood phosphorus increased 28.36 24.97 10 4625 4308 90619504
Foot fracture 27.32 24.97 17 4618 26589 90597223
Injection site rash 26.23 24.97 16 4619 24157 90599655
Injection site induration 25.87 24.97 12 4623 10456 90613356
Walking distance test abnormal 25.76 24.97 6 4629 587 90623225

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
Injection site atrophy 191.71 48.21 23 983 64 42620265
Vitamin B6 increased 154.59 48.21 16 990 0 42620329
Injection site reaction 134.33 48.21 37 969 15684 42604645
Injection site erythema 95.18 48.21 30 976 20165 42600164
Injection site pain 93.84 48.21 39 967 57759 42562570
Injection site swelling 87.44 48.21 27 979 16946 42603383
Injection site bruising 53.71 48.21 17 989 11508 42608821
Tooth loss 50.72 48.21 13 993 4141 42616188
Vitamin B6 decreased 49.63 48.21 6 1000 18 42620311
Injection site discolouration 49.48 48.21 11 995 1915 42618414

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
Vitamin B6 increased 178.84 30.15 21 3410 29 110585839
Vitamin B6 decreased 176.84 30.15 21 3410 34 110585834
Injection site atrophy 145.08 30.15 23 3408 476 110585392
Injection site reaction 134.14 30.15 62 3369 89008 110496860
Injection site pain 126.91 30.15 75 3356 177847 110408021
Injection site erythema 115.69 30.15 57 3374 94119 110491749
Arthralgia 77.31 30.15 107 3324 779525 109806343
Injection site swelling 74.62 30.15 37 3394 61753 110524115
Bone pain 69.87 30.15 36 3395 65097 110520771
Injection site discolouration 69.83 30.15 21 3410 9082 110576786
Myalgia 66.41 30.15 55 3376 222326 110363542
Injection site bruising 65.78 30.15 32 3399 51231 110534637
Tooth loss 63.50 30.15 19 3412 8077 110577791
Nephrocalcinosis 57.83 30.15 13 3418 1801 110584067
Injection site hypertrophy 54.31 30.15 8 3423 99 110585769
Fatigue 54.09 30.15 117 3314 1215841 109370027
Blood alkaline phosphatase decreased 53.93 30.15 13 3418 2440 110583428
Vitamin D decreased 51.92 30.15 18 3413 12197 110573671
Craniosynostosis 47.72 30.15 7 3424 84 110585784
Pain in extremity 43.84 30.15 64 3367 487054 110098814
Calcinosis 37.38 30.15 10 3421 2842 110583026
Nephrolithiasis 37.12 30.15 24 3407 66188 110519680
Injection site pruritus 34.84 30.15 21 3410 51237 110534631
Rickets 32.03 30.15 5 3426 93 110585775
Loose tooth 31.53 30.15 9 3422 3244 110582624
Pain 31.51 30.15 82 3349 954873 109630995
Injection site induration 30.68 30.15 12 3419 11371 110574497

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB13 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Enzymes
FDA CS M0000712 Alkaline Phosphatase
FDA EPC N0000191865 Tissue-nonspecific Alkaline Phosphatase

Related Drugs by ATC class:

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

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

DiseaseRelationSNOMED_IDDOID
Hypophosphatasia indication 190859005 DOID:14213




🐶 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
Z633861EIM UNII
D10595 KEGG_DRUG
4035009 VANDF
C3490795 UMLSCUI
CHEBI:753299 CHEBI
CHEMBL2108311 ChEMBL_ID
DB09105 DRUGBANK_ID
9269 INN_ID
C570710 MESH_SUPPLEMENTAL_RECORD_UI
DB05768 DRUGBANK_ID
1720259 RXNORM
236660 MMSL
31258 MMSL
d08390 MMSL
016528 NDDF
57056007 SNOMEDCT_US
715255009 SNOMEDCT_US
715617005 SNOMEDCT_US
D000469 MESH_DESCRIPTOR_UI
18985873 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
STRENSIQ HUMAN PRESCRIPTION DRUG LABEL 1 25682-010 SOLUTION 18 mg SUBCUTANEOUS BLA 32 sections
STRENSIQ HUMAN PRESCRIPTION DRUG LABEL 1 25682-013 SOLUTION 28 mg SUBCUTANEOUS BLA 32 sections
STRENSIQ HUMAN PRESCRIPTION DRUG LABEL 1 25682-016 SOLUTION 40 mg SUBCUTANEOUS BLA 32 sections
STRENSIQ HUMAN PRESCRIPTION DRUG LABEL 1 25682-019 SOLUTION 80 mg SUBCUTANEOUS BLA 32 sections