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

Stem definition	Drug id	CAS RN
human origin	5322	1803171-55-2

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
58.90	mg	P

ADMET properties:

None

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Breakthrough haemolysis	111.74	40.82	11	393	14	63488604
Haemolysis	97.19	40.82	19	385	6749	63481869
Extravascular haemolysis	66.62	40.82	8	396	105	63488513
Suspected COVID-19	41.66	40.82	8	396	2554	63486064
Exposure during pregnancy	41.57	40.82	20	384	155527	63333091

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Haemolysis	122.13	43.79	26	365	8068	34948472
Breakthrough haemolysis	105.54	43.79	11	380	14	34956526
Suspected COVID-19	49.40	43.79	9	382	1230	34955310

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Haemolysis	148.43	48.71	30	474	12782	79731102
Breakthrough haemolysis	101.49	48.71	10	494	13	79743871
Suspected COVID-19	58.66	48.71	11	493	3122	79740762

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AA43	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
MeSH PA	D051056	Complement Inactivating Agents
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents
FDA EPC	N0000175575	Complement Inhibitor
FDA MoA	N0000175974	Complement Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
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
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Complement C5	Secreted	P01031	CO5_HUMAN	ANTIBODY BINDING	Kd	9.36		SCIENTIFIC LITERATURE	DRUG LABEL

External reference:

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

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-022	SOLUTION, CONCENTRATE	300 mg	INTRAVENOUS	BLA	32 sections
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-022	SOLUTION, CONCENTRATE	300 mg	INTRAVENOUS	BLA	32 sections
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-022	SOLUTION, CONCENTRATE	300 mg	INTRAVENOUS	BLA	32 sections
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-025	SOLUTION, CONCENTRATE	300 mg	INTRAVENOUS	BLA	32 sections
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-025	SOLUTION, CONCENTRATE	300 mg	INTRAVENOUS	BLA	32 sections
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-025	SOLUTION, CONCENTRATE	300 mg	INTRAVENOUS	BLA	32 sections
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-028	SOLUTION, CONCENTRATE	1100 mg	INTRAVENOUS	BLA	32 sections
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-028	SOLUTION, CONCENTRATE	1100 mg	INTRAVENOUS	BLA	32 sections
Ultomiris	HUMAN PRESCRIPTION DRUG LABEL	1	25682-028	SOLUTION, CONCENTRATE	1100 mg	INTRAVENOUS	BLA	32 sections