Tox | Related Drugs | 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
70	mg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company
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 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	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 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	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 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	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:

Source	Code	Description
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

avacopan crovalimab-akkz danicopan eculizumab iptacopan pegcetacoplan pozelimab sutimlimab vilobelimab zilucoplan

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
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:

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
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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

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

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: