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

Stem definitionDrug idCAS RN
human origin 5284 1582205-90-0

Description:

MoleculeDescription

Molfile

Synonyms:

  • erenumab
  • erenumab-aooe
  • aimovig
  • AMG 334
  • AMG-334
  • erenumab (genetical recombination)
Erenumab-aooe is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
2.50 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 26, 2018 EMA NOVARTIS EUROPHARM LIMITED
May 17, 2018 FDA AMGEN INC
June 23, 2021 PMDA AMGEN 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
Accidental exposure to product 13965.76 28.17 3243 33860 19814 50548207
Wrong technique in product usage process 11902.65 28.17 3413 33690 52097 50515924
Device difficult to use 4508.73 28.17 1112 35991 8774 50559247
Device issue 2565.07 28.17 835 36268 19137 50548884
Injection site pain 1765.46 28.17 1064 36039 109960 50458061
Device use error 1452.91 28.17 398 36705 4868 50563153
Incorrect dose administered by device 1411.72 28.17 357 36746 3118 50564903
Constipation 1393.77 28.17 1122 35981 184586 50383435
Injection site haemorrhage 1296.25 28.17 513 36590 20833 50547188
Product storage error 1122.79 28.17 398 36705 11826 50556195
Drug dose omission by device 1114.62 28.17 281 36822 2418 50565603
Migraine 819.61 28.17 570 36533 74710 50493311
Underdose 813.37 28.17 363 36740 19915 50548106
Occupational exposure to product 780.96 28.17 195 36908 1605 50566416
Device malfunction 768.41 28.17 320 36783 14801 50553220
Therapeutic response shortened 676.00 28.17 240 36863 7149 50560872
Therapeutic product effect incomplete 664.67 28.17 544 36559 90971 50477050
Incorrect dose administered 645.34 28.17 416 36687 47998 50520023
Injury associated with device 626.20 28.17 184 36919 2933 50565088
Incorrect disposal of product 608.43 28.17 129 36974 453 50567568
Injection site bruising 441.18 28.17 296 36807 36472 50531549
Wrong technique in device usage process 435.34 28.17 132 36971 2354 50565667
Device defective 293.59 28.17 84 37019 1211 50566810
Needle issue 287.50 28.17 129 36974 7146 50560875
Injection site swelling 273.01 28.17 234 36869 41539 50526482
Injection site indentation 208.17 28.17 43 37060 128 50567893
Injection site erythema 204.35 28.17 263 36840 74673 50493348
Injection site urticaria 145.53 28.17 98 37005 12119 50555902
Headache 143.41 28.17 740 36363 505795 50062226
Toxicity to various agents 141.27 28.17 3 37100 212496 50355525
Anaemia 132.80 28.17 15 37088 252441 50315580
Pneumonia 132.49 28.17 56 37047 378345 50189676
Acute kidney injury 129.38 28.17 10 37093 228048 50339973
Therapy non-responder 128.06 28.17 172 36931 50850 50517171
Product dose omission issue 127.17 28.17 358 36745 183480 50384541
Muscle spasms 126.25 28.17 282 36821 125271 50442750
Condition aggravated 121.11 28.17 34 37069 297024 50270997
Injection site extravasation 101.08 28.17 65 37038 7436 50560585
Inappropriate schedule of product administration 97.83 28.17 183 36920 71648 50496373
Diarrhoea 96.74 28.17 178 36925 588298 49979723
Joint swelling 96.42 28.17 30 37073 245256 50322765
Product administered at inappropriate site 95.48 28.17 43 37060 2400 50565621
Neutropenia 94.87 28.17 3 37100 147962 50420059
Incorrect dose administered by product 94.11 28.17 22 37081 132 50567889
Infusion related reaction 91.87 28.17 9 37094 169548 50398473
General physical health deterioration 90.92 28.17 3 37100 142431 50425590
Neovascularisation 89.18 28.17 32 37071 981 50567040
Rheumatoid arthritis 86.65 28.17 21 37082 202529 50365492
Arthropathy 86.55 28.17 8 37095 157898 50410123
Injection site rash 86.54 28.17 81 37022 16096 50551925
Pyrexia 85.25 28.17 92 37011 380111 50187910
Therapeutic product effect decreased 80.68 28.17 251 36852 135799 50432222
Infection 79.96 28.17 15 37088 172939 50395082
Blepharospasm 78.91 28.17 40 37063 2908 50565113
Completed suicide 77.00 28.17 5 37098 131884 50436137
Injection site pruritus 76.19 28.17 119 36984 40292 50527729
Contraindicated product administered 75.44 28.17 10 37093 148948 50419073
Urinary tract infection 72.32 28.17 37 37066 223983 50344038
Incorrect route of product administration 71.49 28.17 78 37025 18588 50549433
Death 69.33 28.17 82 37021 325297 50242724
Glossodynia 68.61 28.17 4 37099 115565 50452456
Oedema peripheral 68.28 28.17 16 37087 157945 50410076
Device failure 67.40 28.17 45 37058 5483 50562538
Product use issue 66.91 28.17 14 37089 149461 50418560
Exposure during pregnancy 66.66 28.17 6 37097 121009 50447012
Drug interaction 65.89 28.17 32 37071 199589 50368432
Systemic lupus erythematosus 65.40 28.17 12 37091 140610 50427411
Wound 61.78 28.17 4 37099 105790 50462231
Fall 61.61 28.17 94 37009 334838 50233183
White blood cell count decreased 61.14 28.17 7 37096 116715 50451306
Feeling abnormal 60.55 28.17 216 36887 125276 50442745
Product supply issue 59.58 28.17 25 37078 1174 50566847
Renal failure 59.51 28.17 5 37098 106628 50461393
Swelling 59.33 28.17 37 37066 200835 50367186
Stomatitis 58.68 28.17 4 37099 101340 50466681
Dyspnoea 58.55 28.17 206 36897 547402 50020619
Sepsis 58.37 28.17 13 37090 132912 50435109
Alopecia 57.53 28.17 341 36762 244706 50323315
Hypotension 56.07 28.17 54 37049 235415 50332606
Migraine with aura 55.37 28.17 29 37074 2256 50565765
Hyponatraemia 55.07 28.17 4 37099 96135 50471886
Product dispensing error 54.38 28.17 48 37055 8843 50559178
Dehydration 54.12 28.17 22 37081 152427 50415594
Injection site mass 54.01 28.17 62 37041 15618 50552403
Product communication issue 53.80 28.17 17 37086 349 50567672
Paradoxical drug reaction 52.61 28.17 33 37070 3614 50564407
Pain 52.20 28.17 233 36870 578670 49989351
Overdose 52.18 28.17 6 37097 99721 50468300
Drug hypersensitivity 50.54 28.17 66 37037 250944 50317077
Fear of injection 49.93 28.17 39 37064 6064 50561957
Alanine aminotransferase increased 49.69 28.17 4 37099 88355 50479666
Hypokalaemia 49.44 28.17 4 37099 87988 50480033
Confusional state 47.40 28.17 40 37063 185888 50382133
Hepatic enzyme increased 46.89 28.17 21 37082 137359 50430662
Injection site injury 46.54 28.17 17 37086 549 50567472
Device delivery system issue 45.39 28.17 16 37087 465 50567556
Aspartate aminotransferase increased 45.38 28.17 3 37100 77995 50490026
Injection site reaction 45.37 28.17 108 36995 49924 50518097
Injection site discolouration 45.37 28.17 39 37064 6935 50561086
Atrial fibrillation 44.56 28.17 10 37093 101735 50466286
Taste disorder 43.22 28.17 41 37062 8283 50559738
Lower respiratory tract infection 42.41 28.17 9 37094 95192 50472829
Gastrointestinal haemorrhage 42.14 28.17 3 37100 73318 50494703
Respiratory failure 41.92 28.17 8 37095 91173 50476848
Asthenia 41.89 28.17 109 36994 318933 50249088
Abdominal discomfort 41.60 28.17 66 37037 231575 50336446
Blood creatinine increased 41.33 28.17 4 37099 76156 50491865
Product packaging issue 40.93 28.17 18 37085 949 50567072
Cardiac failure congestive 39.66 28.17 7 37096 84375 50483646
Cardiac failure 38.73 28.17 5 37098 76035 50491986
Blister 38.21 28.17 8 37095 85410 50482611
Injection site discomfort 37.18 28.17 27 37076 3763 50564258
Drug intolerance 36.96 28.17 65 37038 219039 50348982
Hemiplegic migraine 36.47 28.17 9 37094 70 50567951
Leukopenia 35.48 28.17 4 37099 67524 50500497
Head discomfort 35.33 28.17 42 37061 10977 50557044
Cellulitis 35.24 28.17 5 37098 70793 50497228
Intentional product use issue 34.82 28.17 7 37096 76911 50491110
Intentional overdose 34.67 28.17 3 37100 62501 50505520
Oxygen saturation decreased 34.59 28.17 6 37097 73242 50494779
Arthralgia 34.58 28.17 185 36918 438517 50129504
Therapeutic product effect delayed 33.54 28.17 20 37083 2001 50566020
Peripheral swelling 33.03 28.17 63 37040 205873 50362148
Rubber sensitivity 32.91 28.17 19 37084 1790 50566231
Osteoarthritis 31.57 28.17 6 37097 68600 50499421
Device leakage 30.60 28.17 29 37074 5849 50562172
Drug abuse 30.32 28.17 4 37099 59842 50508179
Cardiac arrest 29.79 28.17 12 37091 83639 50484382
Influenza like illness 29.49 28.17 101 37002 57358 50510663
Post-traumatic neck syndrome 29.37 28.17 18 37085 1892 50566129
Sinusitis 29.29 28.17 50 37053 170508 50397513
Decreased appetite 29.22 28.17 65 37038 200858 50367163
Back pain 28.98 28.17 75 37028 219955 50348066
Therapeutic response unexpected 28.78 28.17 46 37057 15869 50552152
Drug delivery system issue 28.77 28.17 6 37097 19 50568002
Lack of injection site rotation 28.49 28.17 10 37093 287 50567734
Coma 28.35 28.17 4 37099 56875 50511146
Vertigo 28.27 28.17 93 37010 51739 50516282

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
Accidental exposure to product 2897.72 58.44 586 3942 10167 29559832
Wrong technique in product usage process 1745.87 58.44 477 4051 30951 29539048
Device difficult to use 564.33 58.44 110 4418 1476 29568523
Device issue 473.65 58.44 128 4400 7652 29562347
Occupational exposure to product 347.40 58.44 57 4471 254 29569745
Incorrect dose administered by device 306.64 58.44 66 4462 1473 29568526
Injection site haemorrhage 269.24 58.44 84 4444 8302 29561697
Migraine 255.97 58.44 89 4439 12341 29557658
Product storage error 242.46 58.44 73 4455 6397 29563602
Therapeutic product effect incomplete 216.86 58.44 110 4418 39195 29530804
Device use error 207.47 58.44 51 4477 2071 29567928
Constipation 194.08 58.44 151 4377 114009 29455990
Injection site pain 182.34 58.44 92 4436 32354 29537645
Underdose 155.53 58.44 61 4467 11808 29558191
Injury associated with device 144.36 58.44 32 4496 819 29569180
Therapeutic response shortened 137.08 58.44 44 4484 4747 29565252
Incorrect disposal of product 101.48 58.44 20 4508 282 29569717
Incorrect dose administered 101.42 58.44 63 4465 32921 29537078
Therapeutic product effect decreased 89.88 58.44 56 4472 29395 29540604
Device malfunction 88.27 58.44 37 4491 8470 29561529
Headache 85.19 58.44 118 4410 173889 29396110
Drug dose omission by device 79.06 58.44 21 4507 1161 29568838
Therapy non-responder 61.26 58.44 45 4483 30866 29539133

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
Accidental exposure to product 15242.07 32.35 3383 32092 22981 64440276
Wrong technique in product usage process 13747.26 32.35 3710 31765 61264 64401993
Device difficult to use 5009.33 32.35 1144 34331 8654 64454603
Device issue 3031.85 32.35 913 34562 21735 64441522
Injection site pain 1934.16 32.35 1024 34451 110384 64352873
Incorrect dose administered by device 1681.29 32.35 401 35074 3696 64459561
Device use error 1628.06 32.35 428 35047 6043 64457214
Injection site haemorrhage 1549.85 32.35 560 34915 23718 64439539
Product storage error 1241.74 32.35 408 35067 12910 64450347
Drug dose omission by device 1201.27 32.35 296 35179 3161 64460096
Underdose 981.67 32.35 409 35066 25420 64437837
Migraine 945.31 32.35 526 34949 62151 64401106
Constipation 911.07 32.35 853 34622 228484 64234773
Device malfunction 884.19 32.35 341 35134 17292 64445965
Incorrect dose administered 774.24 32.35 457 35018 60308 64402949
Therapeutic product effect incomplete 762.52 32.35 552 34923 102930 64360327
Injury associated with device 752.31 32.35 196 35279 2657 64460600
Incorrect disposal of product 631.69 32.35 135 35340 708 64462549
Therapeutic response shortened 550.28 32.35 208 35267 9962 64453295
Wrong technique in device usage process 480.24 32.35 138 35337 2744 64460513
Injection site bruising 450.93 32.35 269 35206 36104 64427153
Device defective 342.33 32.35 89 35386 1194 64462063
Needle issue 319.19 32.35 137 35338 9135 64454122
Injection site indentation 265.41 32.35 50 35425 116 64463141
Injection site swelling 245.00 32.35 194 35281 41159 64422098
Occupational exposure to product 235.35 32.35 57 35418 561 64462696
Injection site erythema 210.86 32.35 226 35249 70574 64392683
Headache 210.19 32.35 703 34772 528764 63934493
Product dose omission issue 206.82 32.35 378 35097 194369 64268888
Acute kidney injury 202.65 32.35 11 35464 449229 64014028
Toxicity to various agents 184.89 32.35 3 35472 363510 64099747
Pneumonia 173.41 32.35 47 35428 559529 63903728
Anaemia 154.34 32.35 15 35460 378665 64084592
Therapy non-responder 141.81 32.35 178 35297 65721 64397536
Therapeutic product effect decreased 133.96 32.35 233 35242 115118 64348139
Incorrect dose administered by product 127.21 32.35 27 35448 136 64463121
Injection site urticaria 121.31 32.35 76 35399 11105 64452152
Inappropriate schedule of product administration 118.51 32.35 195 35280 92091 64371166
Pyrexia 116.34 32.35 83 35392 558561 63904696
Drug interaction 114.68 32.35 29 35446 362054 64101203
Neutropenia 114.05 32.35 4 35471 239620 64223637
Injection site extravasation 108.50 32.35 63 35412 8023 64455234
Condition aggravated 106.65 32.35 36 35439 372390 64090867
Muscle spasms 96.81 32.35 229 35246 140794 64322463
Completed suicide 96.53 32.35 7 35468 224407 64238850
Neovascularisation 95.52 32.35 32 35443 1071 64462186
Drug ineffective 95.08 32.35 786 34689 839461 63623796
Product administered at inappropriate site 94.17 32.35 42 35433 3068 64460189
Death 93.69 32.35 77 35398 482628 63980629
Diarrhoea 93.62 32.35 159 35316 722545 63740712
Sepsis 86.59 32.35 12 35463 230329 64232928
Device failure 86.20 32.35 48 35427 5644 64457613
Renal failure 83.19 32.35 4 35471 181684 64281573
Feeling abnormal 80.08 32.35 206 35269 133396 64329861
Platelet count decreased 79.08 32.35 3 35472 167708 64295549
Hypotension 78.66 32.35 57 35418 380917 64082340
Incorrect route of product administration 75.75 32.35 78 35397 23220 64440037
Oedema peripheral 74.41 32.35 13 35462 210304 64252953
Infusion related reaction 74.09 32.35 4 35471 164463 64298794
Blepharospasm 72.61 32.35 36 35439 3339 64459918
Atrial fibrillation 69.02 32.35 7 35468 171082 64292175
White blood cell count decreased 67.64 32.35 5 35470 157832 64305425
Dyspnoea 65.96 32.35 191 35284 718483 63744774
Injection site mass 65.73 32.35 63 35412 17207 64446050
Hyponatraemia 65.61 32.35 4 35471 148335 64314922
Alanine aminotransferase increased 63.83 32.35 3 35472 139028 64324229
Overdose 60.69 32.35 8 35467 159558 64303699
Drug abuse 60.31 32.35 3 35472 132371 64330886
Urinary tract infection 60.21 32.35 26 35449 231570 64231687
Dehydration 60.18 32.35 22 35453 216741 64246516
Infection 60.04 32.35 14 35461 184866 64278391
Injection site rash 59.11 32.35 57 35418 15685 64447572
Blood creatinine increased 59.04 32.35 4 35471 135778 64327479
Product communication issue 58.01 32.35 18 35457 469 64462788
Alopecia 57.48 32.35 211 35264 165479 64297778
Cardiac failure 57.27 32.35 4 35471 132369 64330888
Gastrointestinal haemorrhage 57.24 32.35 4 35471 132308 64330949
Respiratory failure 56.92 32.35 10 35465 161173 64302084
Injection site pruritus 56.91 32.35 86 35389 37740 64425517
Product supply issue 56.24 32.35 23 35452 1356 64461901
Hypokalaemia 54.79 32.35 3 35472 121900 64341357
Product dispensing error 53.79 32.35 47 35428 11403 64451854
Aspartate aminotransferase increased 53.67 32.35 3 35472 119785 64343472
Fall 53.52 32.35 92 35383 416734 64046523
Device delivery system issue 52.58 32.35 16 35459 390 64462867
Injection site discomfort 51.54 32.35 31 35444 4210 64459047
Injection site discolouration 51.19 32.35 37 35438 6838 64456419
Cardiac arrest 49.36 32.35 12 35463 154052 64309205
Joint swelling 48.76 32.35 29 35446 215353 64247904
Cardiac failure congestive 48.58 32.35 7 35468 130573 64332684
Therapeutic product effect delayed 48.34 32.35 25 35450 2534 64460723
Stomatitis 48.33 32.35 3 35472 109602 64353655
Migraine with aura 47.79 32.35 24 35451 2288 64460969
Rheumatoid arthritis 46.74 32.35 16 35459 164278 64298979
Fear of injection 46.74 32.35 33 35442 5879 64457378
Asthenia 45.89 32.35 105 35370 427939 64035318
Paradoxical drug reaction 45.71 32.35 33 35442 6087 64457170
Product packaging issue 45.69 32.35 18 35457 962 64462295
Multiple organ dysfunction syndrome 44.05 32.35 3 35472 101410 64361847
Arthropathy 43.82 32.35 7 35468 120960 64342297
Confusional state 43.15 32.35 48 35427 261096 64202161
Leukopenia 41.19 32.35 4 35471 101238 64362019
Product use issue 41.08 32.35 16 35459 151699 64311558
Intentional product use issue 40.90 32.35 3 35472 95361 64367896
Taste disorder 40.89 32.35 37 35438 9396 64453861
Septic shock 40.78 32.35 5 35470 105432 64357825
Head discomfort 39.15 32.35 40 35435 11794 64451463
Injection site injury 37.60 32.35 14 35461 641 64462616
Oxygen saturation decreased 37.07 32.35 7 35468 107169 64356088
C-reactive protein increased 35.50 32.35 5 35470 94904 64368353
Decreased appetite 35.23 32.35 63 35412 281226 64182031
Cellulitis 34.88 32.35 5 35470 93652 64369605
Influenza like illness 34.74 32.35 93 35382 61609 64401648
Post-traumatic neck syndrome 34.27 32.35 18 35457 1884 64461373
Therapeutic response unexpected 33.51 32.35 44 35431 16957 64446300
Hypoglycaemia 33.01 32.35 5 35470 89887 64373370
Swelling 32.96 32.35 24 35451 160194 64303063
Electrocardiogram QT prolonged 32.69 32.35 3 35472 79445 64383812

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02CD01 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 receptor GPCR ANTIBODY BINDING Ki 10.70 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
I5I8VB78VT UNII
C4542165 UMLSCUI
CHEMBL3833329 ChEMBL_ID
DB14039 DRUGBANK_ID
D10928 KEGG_DRUG
9250 IUPHAR_LIGAND_ID
2045613 RXNORM
279240 MMSL
34247 MMSL
d08796 MMSL
771590007 SNOMEDCT_US
771675000 SNOMEDCT_US
4037572 VANDF
017547 NDDF
C000605816 MESH_SUPPLEMENTAL_RECORD_UI
10296 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
AIMOVIG HUMAN PRESCRIPTION DRUG LABEL 1 55513-840 INJECTION 70 mg SUBCUTANEOUS BLA 30 sections
AIMOVIG HUMAN PRESCRIPTION DRUG LABEL 1 55513-840 INJECTION 70 mg SUBCUTANEOUS BLA 30 sections
AIMOVIG HUMAN PRESCRIPTION DRUG LABEL 1 55513-841 INJECTION 70 mg SUBCUTANEOUS BLA 30 sections
AIMOVIG HUMAN PRESCRIPTION DRUG LABEL 1 55513-841 INJECTION 70 mg SUBCUTANEOUS BLA 30 sections
AIMOVIG HUMAN PRESCRIPTION DRUG LABEL 1 55513-842 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 30 sections
AIMOVIG HUMAN PRESCRIPTION DRUG LABEL 1 55513-842 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 30 sections
AIMOVIG HUMAN PRESCRIPTION DRUG LABEL 1 55513-843 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 30 sections
AIMOVIG HUMAN PRESCRIPTION DRUG LABEL 1 55513-843 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 30 sections