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

Stem definitionDrug idCAS RN
human origin 5309 1426055-14-2

Description:

MoleculeDescription

Synonyms:

  • lanadelumab
  • DX-2930
  • Lanadelumab-fyo
  • SHP 643
  • takhzyro
  • lanadelumab (genetical recombination)
Lanadelumab-flyo is a fully human monoclonal antibody (IgG1/kappa-light chain) that binds plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE.In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Lanadelumab-flyo decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
21.40 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Nov. 22, 2018 EMA SHIRE PHARMACEUTICALS IRELAND LTD
Aug. 23, 2018 FDA DYAX CORP
March 28, 2022 PMDA Takeda Pharmaceutical Company Limited

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
Hereditary angioedema 2065.07 34.29 352 2908 7210 63478552
Product dose omission issue 290.76 34.29 168 3092 234145 63251617
Inappropriate schedule of product administration 188.00 34.29 96 3164 103869 63381893
Product availability issue 149.33 34.29 36 3224 4085 63481677
COVID-19 123.42 34.29 75 3185 113028 63372734
Injection site pain 118.85 34.29 77 3183 129723 63356039
Insurance issue 84.82 34.29 25 3235 6096 63479666
Weight increased 66.46 34.29 74 3186 260718 63225044
Weight decreased 66.23 34.29 76 3184 276722 63209040
Stress 64.16 34.29 41 3219 67126 63418636
No adverse event 49.02 34.29 29 3231 41376 63444386
Product distribution issue 39.33 34.29 10 3250 1406 63484356

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
Hereditary angioedema 580.34 54.20 79 587 968 34955297
Product dose omission issue 121.23 54.20 54 612 119657 34836608
Inappropriate schedule of product administration 72.01 54.20 31 635 62265 34894000
Product availability issue 63.74 54.20 13 653 1874 34954391
Weight increased 54.39 54.20 29 637 93004 34863261

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
Hereditary angioedema 1877.02 42.18 296 2723 5039 79736330
Product dose omission issue 351.26 42.18 175 2844 247362 79494007
Product availability issue 200.93 42.18 43 2976 3904 79737465
Inappropriate schedule of product administration 184.12 42.18 93 2926 133535 79607834
Injection site pain 140.64 42.18 77 2942 129761 79611608
COVID-19 134.52 42.18 80 2939 157594 79583775
Weight increased 104.18 42.18 85 2934 277301 79464068
Weight decreased 101.36 42.18 93 2926 355105 79386264
Insurance issue 79.91 42.18 22 2997 5711 79735658
Product distribution issue 69.99 42.18 15 3004 1365 79740004
Stress 58.99 42.18 37 2982 79575 79661794
Weight fluctuation 45.53 42.18 17 3002 11658 79729711

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B06AC05 BLOOD AND BLOOD FORMING ORGANS
OTHER HEMATOLOGICAL AGENTS
OTHER HEMATOLOGICAL AGENTS
Drugs used in hereditary angioedema
FDA MoA N0000184151 Kallikrein Inhibitors
FDA EPC N0000192750 Plasma Kallikrein Inhibitor

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

DiseaseRelationSNOMED_IDDOID
Hereditary angioneurotic edema indication 82966003 DOID:14735




🐶 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Plasma kallikrein Enzyme ANTIBODY BINDING IC50 10.05 IUPHAR DRUG LABEL

External reference:

IDSource
2372V1TKXK UNII
C4505508 UMLSCUI
CHEMBL3545189 ChEMBL_ID
DB14597 DRUGBANK_ID
D11094 KEGG_DRUG
10265 INN_ID
9094 IUPHAR_LIGAND_ID
773956002 SNOMEDCT_US
773961000 SNOMEDCT_US
4037795 VANDF
2055641 RXNORM
288339 MMSL
34817 MMSL
d08864 MMSL
C000596550 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TAKHZYRO HUMAN PRESCRIPTION DRUG LABEL 1 47783-644 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 30 sections
TAKHZYRO HUMAN PRESCRIPTION DRUG LABEL 1 47783-644 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 30 sections
TAKHZYRO HUMAN PRESCRIPTION DRUG LABEL 1 47783-645 SOLUTION 150 mg SUBCUTANEOUS BLA 30 sections
TAKHZYRO HUMAN PRESCRIPTION DRUG LABEL 1 47783-646 SOLUTION 300 mg SUBCUTANEOUS BLA 30 sections
TAKHZYRO HUMAN PRESCRIPTION DRUG LABEL 1 47783-646 SOLUTION 300 mg SUBCUTANEOUS BLA 30 sections