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

Stem definitionDrug idCAS RN
human origin 5316 1578199-75-3

Description:

MoleculeDescription

Synonyms:

  • galcanezumab
  • emgality
  • LY2951742
  • galcanezumab-gnlm
Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
4 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 27, 2018 FDA ELI LILLY AND CO
Jan. 22, 2021 PMDA Eli Lilly Japan K.K.

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
Underdose 804.34 28.63 228 5644 27228 63455922
Injection site pain 626.48 28.63 282 5590 129518 63353632
Accidental underdose 342.05 28.63 60 5812 743 63482407
Injection site erythema 332.22 28.63 159 5713 83015 63400135
Injection site reaction 283.60 28.63 128 5744 58396 63424754
Injection site pruritus 278.30 28.63 117 5755 44999 63438151
Injection site urticaria 226.75 28.63 74 5798 13999 63469151
Injection site swelling 214.41 28.63 99 5773 47473 63435677
Migraine 196.77 28.63 121 5751 103225 63379925
Therapeutic response shortened 138.35 28.63 49 5823 11839 63471311
Injection site rash 136.93 28.63 55 5817 18754 63464396
Injection site mass 110.22 28.63 47 5825 18609 63464541
Incorrect dose administered 103.31 28.63 66 5806 59902 63423248
Product dose omission issue 99.35 28.63 115 5757 234198 63248952
Injection site haemorrhage 92.24 28.63 45 5827 24269 63458881
Headache 80.80 28.63 179 5693 633062 62850088
Constipation 70.55 28.63 95 5777 224848 63258302
Weight increased 55.68 28.63 92 5780 260700 63222450
Urticaria 54.96 28.63 72 5800 165730 63317420
Injection site warmth 54.26 28.63 27 5845 15168 63467982
Alopecia 44.56 28.63 97 5775 337439 63145711
Injection site bruising 41.62 28.63 33 5839 41877 63441273
Incorrect product formulation administered 37.02 28.63 7 5865 134 63483016
Product storage error 29.59 28.63 18 5854 14938 63468212
Device difficult to use 29.51 28.63 17 5855 12779 63470371

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
Underdose 190.55 54.95 44 521 13736 34942630
Injection site pain 71.92 54.95 26 539 38979 34917387
Injection site erythema 67.70 54.95 20 545 15879 34940487

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
Underdose 237.47 32.74 77 3134 33074 79708103
Injection site pain 207.74 32.74 102 3109 129736 79611441
Injection site erythema 202.66 32.74 86 3125 78111 79663066
Injection site pruritus 174.08 32.74 65 3146 42218 79698959
Migraine 137.47 32.74 68 3143 87425 79653752
Accidental underdose 126.53 32.74 23 3188 839 79740338
Injection site reaction 118.10 32.74 53 3158 54732 79686445
Injection site urticaria 100.72 32.74 32 3179 12794 79728383
Injection site swelling 99.66 32.74 45 3166 47087 79694090
Injection site rash 67.97 32.74 26 3185 17928 79723249
Injection site mass 61.56 32.74 25 3186 20159 79721018
Headache 52.69 32.74 94 3117 653678 79087499
Device difficult to use 42.25 32.74 17 3194 13368 79727809
Product dose omission issue 40.85 32.74 50 3161 247487 79493690
Alopecia 40.25 32.74 48 3163 231307 79509870
Wrong technique in product usage process 40.12 32.74 29 3182 73846 79667331
Incorrect dose administered 39.17 32.74 29 3182 76601 79664576
Injection site haemorrhage 38.79 32.74 20 3191 27850 79713327
Injection site warmth 34.01 32.74 15 3196 14792 79726385
Urticaria 33.13 32.74 39 3172 185162 79556015

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02CD02 NERVOUS SYSTEM
ANALGESICS
ANTIMIGRAINE PREPARATIONS
Calcitonin gene-related peptide (CGRP) antagonists
MeSH PA D000700 Analgesics
MeSH PA D000077221 Calcitonin Gene-Related Peptide Receptor Antagonists
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

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

DiseaseRelationSNOMED_IDDOID
Migraine indication 37796009 DOID:6364




🐶 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
Calcitonin gene-related peptide 1 GPCR ANTIBODY BINDING Kd 8.70 IUPHAR DRUG LABEL

External reference:

IDSource
55KHL3P693 UNII
C4694273 UMLSCUI
CHEMBL3707328 ChEMBL_ID
DB14042 DRUGBANK_ID
D10936 KEGG_DRUG
10277 INN_ID
C000605816 MESH_SUPPLEMENTAL_RECORD_UI
8967 IUPHAR_LIGAND_ID
017757 NDDF
782371005 SNOMEDCT_US
782419003 SNOMEDCT_US
4037908 VANDF
4037909 VANDF
2058846 RXNORM
291703 MMSL
35092 MMSL
35093 MMSL
d08941 MMSL
C000628360 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
EMGALITY HUMAN PRESCRIPTION DRUG LABEL 1 0002-1436 INJECTION, SOLUTION 120 mg SUBCUTANEOUS BLA 29 sections
EMGALITY HUMAN PRESCRIPTION DRUG LABEL 1 0002-2377 INJECTION, SOLUTION 120 mg SUBCUTANEOUS BLA 29 sections
EMGALITY HUMAN PRESCRIPTION DRUG LABEL 1 0002-3115 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 29 sections