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

Stem definitionDrug idCAS RN
human origin 5315 1655501-53-3

Description:

MoleculeDescription

Synonyms:

  • fremanezumab
  • ajovy
  • TEV-48125
  • LBR-101
  • RN307
  • PF-04472429
  • fremanezumab-vfrm
  • fremanezumab (genetical recombination)
Fremanezumab-vfrm 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
7.50 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 28, 2019 EMA TEVA GMBH
Sept. 14, 2018 FDA TEVA PHARMS USA
June 23, 2021 PMDA OTSUKA PHARMACEUTICAL Co., Ltd.

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
Injection site erythema 272.11 32.34 117 3272 83057 63402576
Injection site pruritus 224.94 32.34 86 3303 45030 63440603
Injection site rash 186.94 32.34 60 3329 18749 63466884
Injection site swelling 168.72 32.34 71 3318 47501 63438132
Injection site reaction 167.27 32.34 75 3314 58449 63427184
Injection site pain 146.15 32.34 89 3300 129711 63355922
Accidental exposure to product 128.39 32.34 50 3339 27355 63458278
Device leakage 110.50 32.34 32 3357 7064 63478569
Incorrect dose administered by device 106.55 32.34 28 3361 4320 63481313
Injection site urticaria 81.50 32.34 30 3359 14043 63471590
Drug dose omission by device 67.46 32.34 20 3369 4781 63480852
Migraine 53.10 32.34 44 3345 103302 63382331
Injection site mass 50.28 32.34 23 3366 18633 63467000
Device malfunction 48.08 32.34 22 3367 17835 63467798
Needle issue 45.26 32.34 18 3371 10358 63475275
Urticaria 43.95 32.34 49 3340 165753 63319880
Device delivery system issue 39.57 32.34 9 3380 760 63484873
Medication overuse headache 38.86 32.34 9 3380 823 63484810
Injection site warmth 38.65 32.34 18 3371 15177 63470456
Wrong technique in device usage process 37.83 32.34 12 3377 3586 63482047
Pruritus 37.31 32.34 68 3321 361385 63124248
Device defective 35.71 32.34 10 3379 1952 63483681
Injection site extravasation 33.96 32.34 14 3375 8827 63476806
Status migrainosus 33.89 32.34 6 3383 140 63485493

FDA Adverse Event Reporting System (Male)

None

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
Injection site erythema 181.82 34.72 73 2304 78124 79663887
Injection site pruritus 181.58 34.72 62 2315 42221 79699790
Injection site swelling 134.11 34.72 51 2326 47081 79694930
Injection site rash 95.57 34.72 31 2346 17923 79724088
Injection site reaction 83.51 34.72 38 2339 54747 79687264
Injection site pain 62.32 34.72 42 2335 129796 79612215
Accidental exposure to product 54.97 34.72 24 2353 31298 79710713
Injection site urticaria 51.78 34.72 18 2359 12808 79729203
Device leakage 46.79 34.72 16 2361 10840 79731171
Drug dose omission by device 42.41 34.72 13 2364 6237 79735774
Migraine 41.21 34.72 28 2349 87465 79654546

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02CD03 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
Prevention of migraine attacks indication 408381007




🐶 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 10.30 IUPHAR DRUG LABEL

External reference:

IDSource
PF8K38CG54 UNII
C4549503 UMLSCUI
CHEMBL4297756 ChEMBL_ID
DB14041 DRUGBANK_ID
D11055 KEGG_DRUG
10299 INN_ID
C000605816 MESH_SUPPLEMENTAL_RECORD_UI
9208 IUPHAR_LIGAND_ID
017742 NDDF
781125008 SNOMEDCT_US
781150006 SNOMEDCT_US
4037844 VANDF
4037845 VANDF
2056690 RXNORM
289669 MMSL
34962 MMSL
34963 MMSL
d08897 MMSL
C000604315 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
AJOVY HUMAN PRESCRIPTION DRUG LABEL 1 51759-202 INJECTION 225 mg SUBCUTANEOUS BLA 27 sections
AJOVY HUMAN PRESCRIPTION DRUG LABEL 1 51759-202 INJECTION 225 mg SUBCUTANEOUS BLA 27 sections
AJOVY HUMAN PRESCRIPTION DRUG LABEL 1 51759-202 INJECTION 225 mg SUBCUTANEOUS BLA 27 sections
AJOVY HUMAN PRESCRIPTION DRUG LABEL 1 51759-204 INJECTION 225 mg SUBCUTANEOUS BLA 27 sections
AJOVY HUMAN PRESCRIPTION DRUG LABEL 1 51759-204 INJECTION 225 mg SUBCUTANEOUS BLA 27 sections
AJOVY HUMAN PRESCRIPTION DRUG LABEL 1 51759-204 INJECTION 225 mg SUBCUTANEOUS BLA 27 sections