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

Stem definition	Drug id	CAS RN
human origin	4952	914613-48-2

Description:

Molecule	Description
Synonyms: canakinumab ilaris ACZ885	a human anti-interleukin-1beta monoclonal antibody for treatment of cryopyrin-associated periodic syndrome Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

canakinumab
ilaris
ACZ885

a human anti-interleukin-1beta monoclonal antibody for treatment of cryopyrin-associated periodic syndrome

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
2.70	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
Oct. 23, 2009	EMA
June 17, 2009	FDA	NOVARTIS PHARMS
Sept. 26, 2011	PMDA	Novartis Pharma K.K.

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
Inappropriate schedule of product administration	797.82	18.24	349	8107	103616	63376950
Haemophagocytic lymphohistiocytosis	306.55	18.24	95	8361	10532	63470034
Pyrexia	297.14	18.24	337	8119	470141	63010425
Incorrect dose administered	171.46	18.24	104	8352	59864	63420702
Serum ferritin increased	116.24	18.24	40	8416	6142	63474424
Serum amyloid A protein increased	114.42	18.24	22	8434	314	63480252
COVID-19	88.08	18.24	91	8365	113012	63367554
Illness	79.74	18.24	60	8396	48999	63431567
Clubbing	79.24	18.24	17	8439	429	63480137
Condition aggravated	70.43	18.24	161	8295	402056	63078510
Lymphadenopathy	62.41	18.24	47	8409	38411	63442155
Hepatosplenomegaly	53.39	18.24	18	8438	2596	63477970
C-reactive protein increased	51.09	18.24	63	8393	94644	63385922
Malaise	50.39	18.24	145	8311	415809	63064757
SARS-CoV-2 test positive	48.60	18.24	23	8433	8033	63472533
Symptom recurrence	47.22	18.24	15	8441	1795	63478771
Product use in unapproved indication	45.82	18.24	84	8372	178996	63301570
Concomitant disease aggravated	40.11	18.24	21	8435	9091	63471475
Drug reaction with eosinophilia and systemic symptoms	39.27	18.24	34	8422	33802	63446764
Epstein-Barr virus infection	36.71	18.24	19	8437	8031	63472535
Gastroenteritis	35.56	18.24	29	8427	26561	63454005
Product supply issue	35.50	18.24	12	8444	1743	63478823
Juvenile idiopathic arthritis	34.80	18.24	14	8442	3312	63477254
Pneumonia lipoid	34.72	18.24	7	8449	129	63480437
Blood lactate dehydrogenase increased	32.58	18.24	26	8430	23090	63457476
Tonsillitis	30.44	18.24	15	8441	5720	63474846
Blood creatine phosphokinase decreased	29.87	18.24	8	8448	525	63480041
Arthralgia	29.83	18.24	152	8304	569558	62911008
Cough	29.68	18.24	96	8360	292647	63187919
Rhinorrhoea	28.15	18.24	39	8417	65538	63415028
Oropharyngeal pain	27.59	18.24	47	8409	94440	63386126
Cellulitis staphylococcal	27.19	18.24	8	8448	740	63479826
Pharyngitis streptococcal	26.62	18.24	17	8439	10655	63469911
Influenza	25.28	18.24	49	8407	108673	63371893
Autoinflammatory disease	25.04	18.24	6	8450	251	63480315
Rash	24.18	18.24	142	8314	560729	62919837
Actinomycotic sepsis	23.96	18.24	5	8451	110	63480456
Familial cold autoinflammatory syndrome	23.77	18.24	3	8453	0	63480566
Abdominal pain	23.47	18.24	89	8367	293367	63187199
Cytopenia	22.96	18.24	16	8440	11585	63468981
Normal newborn	22.60	18.24	14	8442	8327	63472239
Infusion related reaction	22.59	18.24	3	8453	245518	63235048
Interleukin level increased	22.01	18.24	6	8450	421	63480145
Ileal ulcer	21.22	18.24	6	8450	482	63480084
Familial mediterranean fever	20.61	18.24	4	8452	60	63480506
Asteatosis	20.55	18.24	4	8452	61	63480505
Drug hypersensitivity	20.30	18.24	8	8448	310679	63169887
Focal nodular hyperplasia	20.29	18.24	6	8450	565	63480001
Drug intolerance	20.08	18.24	8	8448	308653	63171913
Amyloidosis	20.00	18.24	7	8449	1128	63479438
Syringe issue	19.82	18.24	9	8447	2860	63477706
Contraindicated product administered	19.22	18.24	3	8453	217645	63262921
Wrist deformity	19.00	18.24	8	8448	2122	63478444
Splenomegaly	18.90	18.24	14	8442	11143	63469423
Sputum abnormal	18.79	18.24	6	8450	730	63479836
Fall	18.62	18.24	15	8441	392319	63088247
Interstitial lung disease	18.33	18.24	31	8425	61877	63418689
Cryopyrin associated periodic syndrome	18.29	18.24	5	8451	355	63480211

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
Apparent death	1011.78	27.66	227	9215	3417	34944072
Diverticulitis	701.81	27.66	246	9196	19758	34927731
Joint swelling	481.41	27.66	260	9182	59630	34887859
Deep vein thrombosis	396.50	27.66	236	9206	65012	34882477
Inappropriate schedule of product administration	390.74	27.66	230	9212	62066	34885423
Pulmonary thrombosis	386.38	27.66	123	9319	7284	34940205
Red blood cell sedimentation rate increased	372.49	27.66	126	9316	9036	34938453
Pulmonary embolism	360.33	27.66	250	9192	89496	34857993
Terminal state	302.13	27.66	88	9354	3846	34943643
Renal failure	269.49	27.66	246	9196	130311	34817178
Pain	259.05	27.66	296	9146	204379	34743110
C-reactive protein abnormal	244.41	27.66	91	9351	8619	34938870
Thrombosis	182.10	27.66	132	9310	50326	34897163
C-reactive protein increased	178.31	27.66	134	9308	53964	34893525
Photosensitivity reaction	163.34	27.66	72	9370	10522	34936967
Intestinal sepsis	154.74	27.66	36	9406	635	34946854
Joint arthroplasty	154.67	27.66	38	9404	853	34946636
Haemophagocytic lymphohistiocytosis	146.37	27.66	71	9371	12902	34934587
Drug ineffective	132.67	27.66	342	9100	456409	34491080
Contraindicated product administered	112.85	27.66	71	9371	21410	34926079
Sepsis	104.52	27.66	172	9270	166389	34781100
Intentional product use issue	98.82	27.66	100	9342	59716	34887773
Herpes zoster	97.50	27.66	78	9364	34321	34913168
Arthropathy	89.28	27.66	67	9375	26840	34920649
Stent placement	86.35	27.66	37	9405	5041	34942448
Stomatitis	85.08	27.66	79	9363	42435	34905054
Interstitial lung disease	82.94	27.66	95	9347	65187	34882302
Pyrexia	80.79	27.66	234	9208	332779	34614710
Knee arthroplasty	75.77	27.66	38	9404	7406	34940083
Feeling abnormal	73.62	27.66	88	9354	63147	34884342
Incorrect dose administered	72.90	27.66	71	9371	40444	34907045
Serum amyloid A protein increased	72.72	27.66	13	9429	53	34947436
Illness	71.73	27.66	45	9397	13484	34934005
Urticaria	69.66	27.66	85	9357	62292	34885197
Drug intolerance	66.23	27.66	81	9361	59489	34888000
Drug interaction	46.30	27.66	4	9438	225942	34721547
Myocardial infarction	44.71	27.66	100	9342	120985	34826504
Juvenile idiopathic arthritis	43.06	27.66	17	9425	1880	34945609
Off label use	41.25	27.66	222	9220	419302	34528187
Toxicity to various agents	39.83	27.66	4	9438	200358	34747131
Drug hypersensitivity	38.50	27.66	74	9368	80455	34867034
Tonsillitis	35.86	27.66	16	9426	2400	34945089
Nausea	33.24	27.66	26	9416	339882	34607607
Dyspnoea	33.01	27.66	32	9410	376750	34570739
Hypotension	30.36	27.66	11	9431	221638	34725851
Concomitant disease aggravated	30.30	27.66	19	9423	5682	34941807

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
Inappropriate schedule of product administration	594.72	20.03	337	13372	133291	79597388
Apparent death	421.57	20.03	98	13611	2767	79727912
Pulmonary thrombosis	308.63	20.03	105	13604	12066	79718613
Haemophagocytic lymphohistiocytosis	306.97	20.03	122	13587	21715	79708964
Terminal state	280.98	20.03	79	13630	4810	79725869
Pyrexia	276.85	20.03	449	13260	678260	79052419
Red blood cell sedimentation rate increased	223.09	20.03	123	13586	45819	79684860
Diverticulitis	212.15	20.03	119	13590	45817	79684862
Incorrect dose administered	188.21	20.03	133	13576	76497	79654182
C-reactive protein increased	179.03	20.03	160	13549	128867	79601812
Serum amyloid A protein increased	161.29	20.03	31	13678	335	79730344
C-reactive protein abnormal	130.54	20.03	89	13620	48278	79682401
Thrombosis	130.05	20.03	111	13598	83989	79646690
Intestinal sepsis	128.24	20.03	30	13679	869	79729810
Photosensitivity reaction	114.84	20.03	61	13648	21066	79709613
Illness	101.05	20.03	75	13634	46436	79684243
Pulmonary embolism	95.64	20.03	132	13577	171522	79559157
Sepsis	95.32	20.03	168	13541	269260	79461419
Joint arthroplasty	95.12	20.03	30	13679	2710	79727969
Deep vein thrombosis	89.38	20.03	107	13602	120812	79609867
Interstitial lung disease	78.91	20.03	97	13612	112503	79618176
Serum ferritin increased	78.87	20.03	37	13672	9810	79720869
COVID-19	74.27	20.03	112	13597	157562	79573117
Renal failure	73.19	20.03	127	13582	200841	79529838
Stent placement	66.49	20.03	29	13680	6491	79724188
Herpes zoster	64.90	20.03	80	13629	93003	79637676
Urticaria	63.50	20.03	114	13595	185087	79545592
Joint swelling	62.61	20.03	147	13562	288499	79442180
Juvenile idiopathic arthritis	61.31	20.03	25	13684	4738	79725941
Tonsillitis	56.16	20.03	26	13683	6688	79723991
Concomitant disease aggravated	55.06	20.03	32	13677	13135	79717544
Symptom recurrence	54.87	20.03	19	13690	2295	79728384
Drug interaction	46.01	20.03	8	13701	415175	79315504
Product use in unapproved indication	45.27	20.03	119	13590	250240	79480439
Lymphadenopathy	44.11	20.03	50	13659	53197	79677482
Feeling abnormal	43.46	20.03	89	13620	159110	79571569
Pain	43.15	20.03	236	13473	703566	79027113
Condition aggravated	42.90	20.03	185	13524	500939	79229740
SARS-CoV-2 test positive	42.54	20.03	26	13683	11690	79718989
Autoinflammatory disease	41.96	20.03	10	13699	314	79730365
Product supply issue	41.64	20.03	15	13694	2033	79728646
Toxicity to various agents	40.87	20.03	11	13698	421529	79309150
Gastroenteritis	38.94	20.03	38	13671	34044	79696635
Clubbing	38.56	20.03	11	13698	704	79729975
Oropharyngeal pain	37.03	20.03	67	13642	109286	79621393
Pneumonia	36.23	20.03	215	13494	660031	79070648
Hepatosplenomegaly	34.32	20.03	18	13691	6051	79724628
Myocardial infarction	33.75	20.03	88	13621	184041	79546638
Stomatitis	32.03	20.03	75	13634	146682	79583997
Rhinorrhoea	31.54	20.03	51	13658	76023	79654656
Familial mediterranean fever	30.72	20.03	7	13702	180	79730499
Influenza	30.23	20.03	68	13641	129538	79601141
Arthralgia	29.29	20.03	183	13526	571620	79159059
Upper respiratory tract inflammation	28.77	20.03	14	13695	4021	79726658
Cellulitis	28.60	20.03	60	13649	109000	79621679
Asteatosis	28.58	20.03	6	13703	104	79730575
Nausea	27.85	20.03	79	13630	957117	78773562
Growth retardation	27.78	20.03	11	13698	1932	79728747
Intentional product use issue	27.15	20.03	72	13637	152040	79578639
Otitis media	25.95	20.03	15	13694	6091	79724588
Dyspnoea	25.46	20.03	70	13639	856955	78873724
Hypotension	25.40	20.03	23	13686	440294	79290385
Cellulitis staphylococcal	25.39	20.03	9	13700	1164	79729515
Hyperferritinaemia	25.27	20.03	8	13701	731	79729948
Cough	24.43	20.03	126	13583	366663	79364016
Fall	24.16	20.03	29	13680	487600	79243079
Blood creatine phosphokinase decreased	23.11	20.03	8	13701	965	79729714
Actinomycotic sepsis	23.05	20.03	5	13704	102	79730577
Pharyngitis streptococcal	22.63	20.03	17	13692	10697	79719982
Upper respiratory tract infection	22.57	20.03	49	13660	91119	79639560
Drug ineffective	21.79	20.03	282	13427	1080631	78650048
Haemoglobin decreased	20.49	20.03	84	13625	222035	79508644
Secondary adrenocortical insufficiency	20.12	20.03	10	13699	3004	79727675

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L04AC08	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Familial Mediterranean fever	indication	12579009	DOID:2987
Articular gout	indication	48440001	DOID:13189
Deficiency of mevalonate kinase	indication	124327008	DOID:0050452
Systemic onset juvenile chronic arthritis	indication	201796004
TNF receptor-associated periodic fever syndrome (TRAPS)	indication	403833009
Cryopyrin associated periodic syndrome	indication	430079001

🐶 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
Interleukin-1 beta	Cytokine	P01584	IL1B_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D09315	KEGG_DRUG
4028805	VUID
N0000178497	NUI
4028805	VANDF
CHEMBL1201834	ChEMBL_ID
C541220	MESH_SUPPLEMENTAL_RECORD_UI
6773	IUPHAR_LIGAND_ID
DB06168	DRUGBANK_ID
853491	RXNORM
165731	MMSL
26503	MMSL
d07451	MMSL
013212	NDDF
698091001	SNOMEDCT_US
703376008	SNOMEDCT_US
C2718773	UMLSCUI
8836	INN_ID
37CQ2C7X93	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ilaris	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0734	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
Ilaris	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0734	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
Ilaris	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0734	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections