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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Aug. 23, 2018 FDA DYAX CORP
Nov. 22, 2018 EMA SHIRE PHARMACEUTICALS IRELAND LTD
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 2486.89 31.15 421 3872 8944 90615210
Product dose omission issue 231 31.15 153 4140 291534 90332620
Insurance issue 183.78 31.15 51 4242 10907 90613247
Inappropriate schedule of product administration 180.64 31.15 103 4190 149830 90474324
Injection site pain 141.60 31.15 93 4200 173606 90450548
Weight increased 132.09 31.15 128 4165 417799 90206355
Weight decreased 115.53 31.15 114 4179 379796 90244358
Product availability issue 108.40 31.15 31 4262 7373 90616781
No adverse event 74.46 31.15 44 4249 67938 90556216
Stress 72.10 31.15 46 4247 81349 90542805
Illness 62.06 31.15 42 4251 81927 90542227
COVID-19 57.38 31.15 54 4239 168789 90455365
Poor venous access 48.70 31.15 22 4271 19505 90604649
Pharyngeal swelling 48.08 31.15 18 4275 9926 90614228
Product distribution issue 43.16 31.15 13 4280 3692 90620462
Injection site erythema 40.30 31.15 35 4258 98467 90525687
Injection site bruising 37.66 31.15 26 4267 52281 90571873
Laryngeal oedema 35.26 31.15 13 4280 6868 90617286

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 701.88 46.06 99 825 1382 42619029
Product dose omission issue 100.94 46.06 54 870 154311 42466100
Weight increased 82.47 46.06 42 882 107941 42512470
Inappropriate schedule of product administration 63.65 46.06 34 890 95868 42524543
Weight decreased 54.76 46.06 41 883 207907 42412504
Injection site pain 48.40 46.06 24 900 57774 42562637

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 2307.48 35.06 368 3801 6746 110578384
Product dose omission issue 283.31 35.06 166 4003 321616 110263514
Weight increased 189.61 35.06 143 4026 419501 110165629
Inappropriate schedule of product administration 175.85 35.06 104 4065 203533 110381597
Insurance issue 172.91 35.06 46 4123 10566 110574564
Injection site pain 167.14 35.06 96 4073 177826 110407304
Weight decreased 161.09 35.06 136 4033 467921 110117209
Product availability issue 118.12 35.06 32 4137 7858 110577272
Stress 68.41 35.06 45 4124 105303 110479827
COVID-19 67.53 35.06 63 4106 244997 110340133
Product distribution issue 66.79 35.06 18 4151 4328 110580802
Illness 58.01 35.06 37 4132 82134 110502996
Injection site erythema 48.76 35.06 35 4134 94141 110490989
Pharyngeal swelling 48.75 35.06 18 4151 12014 110573116
Injection site bruising 46.21 35.06 27 4142 51236 110533894
Poor venous access 39.40 35.06 19 4150 24503 110560627
No adverse event 37.20 35.06 27 4142 73812 110511318
Weight fluctuation 35.10 35.06 17 4152 22128 110563002

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
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:73336 vulnerary

Related Drugs by ATC class:

B06AC Drugs used in hereditary angioedema 7 drugs
berotralstatconestat alfadonidalorsenecallantidegaradacimabicatibantsebetralstat

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
4037795 VANDF
C4505508 UMLSCUI
CHEBI:755504 CHEBI
CHEMBL3545189 ChEMBL_ID
DB14597 DRUGBANK_ID
D11094 KEGG_DRUG
10265 INN_ID
C000596550 MESH_SUPPLEMENTAL_RECORD_UI
9094 IUPHAR_LIGAND_ID
773956002 SNOMEDCT_US
773961000 SNOMEDCT_US
288339 MMSL
34817 MMSL
d08864 MMSL
2055641 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TAKHZYRO HUMAN PRESCRIPTION DRUG LABEL 1 47783-644 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 29 sections
TAKHZYRO HUMAN PRESCRIPTION DRUG LABEL 1 47783-645 SOLUTION 150 mg SUBCUTANEOUS BLA 29 sections
TAKHZYRO HUMAN PRESCRIPTION DRUG LABEL 1 47783-646 SOLUTION 300 mg SUBCUTANEOUS BLA 29 sections