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

Stem definitionDrug idCAS RN
human origin 5322 1803171-55-2

Description:

MoleculeDescription

Synonyms:

  • ravulizumab
  • ravulizumab-cwvz
  • ultomiris
  • ALXN1210
  • ravulizumab (genetical recombination)
Ravulizumab-cwvz is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex [C5b-9]) and preventing the generation of the terminal complement complex C5b9. ULTOMIRIS inhibits terminal complement-mediated intravascular hemolysis in patients with PNH.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
70 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
June 18, 2019 PMDA ALEXION PHARMA GK
Dec. 21, 2018 FDA ALEXION PHARM
Feb. 7, 2019 EMA ALEXION EUROPE SAS

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
Breakthrough haemolysis 371.25 27.29 49 3449 192 90624757
Extravascular haemolysis 320.69 27.29 45 3453 302 90624647
Haemolysis 263.78 27.29 62 3436 8448 90616501
Myasthenia gravis crisis 194.65 27.29 34 3464 1030 90623919
Symptom recurrence 177.51 27.29 39 3459 3920 90621029
Death 129.35 27.29 120 3378 456431 90168518
Blood lactate dehydrogenase increased 101.39 27.29 38 3460 25894 90599055
Therapeutic response shortened 91.17 27.29 34 3464 22845 90602104
Haemoglobin decreased 89.27 27.29 63 3435 161893 90463056
Meningococcal infection 79.27 27.29 12 3486 143 90624806
Reticulocyte count increased 79.06 27.29 16 3482 1079 90623870
Haptoglobin decreased 73.88 27.29 15 3483 1028 90623921
Exposure during pregnancy 67.81 27.29 63 3435 238347 90386602
Meningococcal sepsis 53.03 27.29 8 3490 93 90624856
Haemoglobinuria 44.09 27.29 8 3490 301 90624648
Meningitis meningococcal 43.75 27.29 7 3491 122 90624827
Eyelid ptosis 34.45 27.29 13 3485 8993 90615956
Bulbar palsy 33.31 27.29 5 3493 56 90624893
Thymoma malignant 32.61 27.29 4 3494 7 90624942
Anaemia 31.51 27.29 52 3446 352750 90272199
Suspected COVID-19 31.29 27.29 9 3489 2677 90622272
Poor venous access 30.65 27.29 15 3483 19512 90605437
Thrombotic microangiopathy 30.56 27.29 14 3484 15729 90609220
Intravascular haemolysis 29.23 27.29 6 3492 434 90624515

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
Haemolysis 324.88 26.96 84 2852 9505 42608894
Breakthrough haemolysis 283.22 26.96 40 2896 141 42618258
Extravascular haemolysis 239.45 26.96 35 2901 166 42618233
Symptom recurrence 187.09 26.96 38 2898 1452 42616947
Myasthenia gravis crisis 151.29 26.96 29 2907 817 42617582
Therapeutic response shortened 134.56 26.96 46 2890 13508 42604891
Death 102.13 26.96 142 2794 471043 42147356
Eyelid ptosis 79.54 26.96 26 2910 6635 42611764
Diplopia 69.71 26.96 32 2904 20284 42598115
Meningococcal sepsis 57.27 26.96 9 2927 74 42618325
Reticulocyte count increased 52.43 26.96 12 2924 805 42617594
Meningococcal infection 48.83 26.96 7 2929 28 42618371
Neisseria infection 43.40 26.96 7 2929 69 42618330
Blood lactate dehydrogenase increased 37.51 26.96 23 2913 26058 42592341
Muscular weakness 35.93 26.96 36 2900 83462 42534937
Infection 35.37 26.96 41 2895 112027 42506372
Haemoglobin decreased 34.55 26.96 44 2892 132427 42485972
Apical granuloma 34.34 26.96 4 2932 0 42618399
Suspected COVID-19 31.75 26.96 9 2927 1421 42616978
Haptoglobin decreased 27.55 26.96 7 2929 729 42617670

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
Haemolysis 362.96 24.73 88 3680 15551 110569980
Breakthrough haemolysis 360.26 24.73 48 3720 239 110585292
Extravascular haemolysis 291.07 24.73 42 3726 404 110585127
Myasthenia gravis crisis 174.46 24.73 33 3735 1781 110583750
Meningococcal infection 114.32 24.73 17 3751 204 110585327
Meningococcal sepsis 93.76 24.73 14 3754 173 110585358
Death 80.06 24.73 108 3660 698761 109886770
Reticulocyte count increased 74.94 24.73 16 3752 1590 110583941
Blood lactate dehydrogenase increased 70.42 24.73 33 3735 44301 110541230
Therapeutic response shortened 62.87 24.73 27 3741 29556 110555975
Eyelid ptosis 56.21 24.73 20 3748 13307 110572224
Meningitis meningococcal 54.92 24.73 9 3759 209 110585322
Haemoglobin decreased 54.75 24.73 54 3714 248673 110336858
Haptoglobin decreased 51.80 24.73 12 3756 1729 110583802
Neisseria infection 47.98 24.73 8 3760 207 110585324
Suspected COVID-19 38.93 24.73 11 3757 3482 110582049
Symptom recurrence 35.54 24.73 11 3757 4761 110580770
Type III immune complex mediated reaction 35.30 24.73 8 3760 1045 110584486
COVID-19 34.35 24.73 42 3726 245018 110340513
Anaemia 32.63 24.73 63 3705 547023 110038508
Marasmus 31.53 24.73 8 3760 1683 110583848
Thymoma malignant 29.66 24.73 4 3764 22 110585509
Mean cell volume increased 29.53 24.73 11 3757 8319 110577212
Homocystinuria 27.86 24.73 3 3765 0 110585531
Thrombotic microangiopathy 26.74 24.73 15 3753 29134 110556397
Diplopia 26.58 24.73 17 3751 41877 110543654
Haemoglobinuria 25.85 24.73 6 3762 871 110584660
Gonococcal infection 25.65 24.73 4 3764 67 110585464
Apical granuloma 25.59 24.73 4 3764 68 110585463
Endothelial dysfunction 25.17 24.73 5 3763 348 110585183
Total complement activity increased 24.92 24.73 3 3765 5 110585526
Intravascular haemolysis 24.91 24.73 6 3762 1021 110584510

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AJ02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Complement inhibitors
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D051056 Complement Inactivating Agents
FDA EPC N0000175575 Complement Inhibitor
FDA MoA N0000175974 Complement Inhibitors
CHEBI has role CHEBI:22587 antiviral agent

Related Drugs by ATC class:

L04AJ Complement inhibitors 10 drugs
avacopancrovalimab-akkzdanicopaneculizumabiptacopanpegcetacoplanpozelimabsutimlimabvilobelimabzilucoplan

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

DiseaseRelationSNOMED_IDDOID
Paroxysmal nocturnal hemoglobinuria indication 1963002 DOID:0060284
Myasthenia gravis indication 91637004 DOID:437
Generalized myasthenia gravis indication 91637004 DOID:437
Atypical hemolytic uremic syndrome (aHUS) indication 789660001
Prevention of relapse of neuromyelitis optica spectrum disorder indication
Meningococcal infectious disease contraindication 23511006




🐶 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
Complement C5 Secreted ANTIBODY BINDING Kd 9.36 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
C3VX249T6L UNII
4038091 VANDF
4038096 VANDF
C4550350 UMLSCUI
CHEBI:756469 CHEBI
CHEMBL3989986 ChEMBL_ID
DB11580 DRUGBANK_ID
D11054 KEGG_DRUG
10659 INN_ID
C000629409 MESH_SUPPLEMENTAL_RECORD_UI
10168 IUPHAR_LIGAND_ID
783439006 SNOMEDCT_US
783573003 SNOMEDCT_US
303377 MMSL
35825 MMSL
35826 MMSL
d09107 MMSL
017866 NDDF
2107301 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ultomiris HUMAN PRESCRIPTION DRUG LABEL 1 25682-022 SOLUTION, CONCENTRATE 300 mg INTRAVENOUS BLA 31 sections
Ultomiris HUMAN PRESCRIPTION DRUG LABEL 1 25682-022 SOLUTION, CONCENTRATE 300 mg INTRAVENOUS BLA 31 sections
Ultomiris HUMAN PRESCRIPTION DRUG LABEL 1 25682-025 SOLUTION, CONCENTRATE 300 mg INTRAVENOUS BLA 31 sections
Ultomiris HUMAN PRESCRIPTION DRUG LABEL 1 25682-025 SOLUTION, CONCENTRATE 300 mg INTRAVENOUS BLA 31 sections
Ultomiris HUMAN PRESCRIPTION DRUG LABEL 1 25682-028 SOLUTION, CONCENTRATE 1100 mg INTRAVENOUS BLA 31 sections
Ultomiris HUMAN PRESCRIPTION DRUG LABEL 1 25682-028 SOLUTION, CONCENTRATE 1100 mg INTRAVENOUS BLA 31 sections