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

Stem definition	Drug id	CAS RN
human origin	5237	1189541-98-7

Description:

Molecule	Description
Synonyms: sarilumab REGN88 SAR153191 kevzara	Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Sarilumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis. Based on encouraging results in China with a similar drug, tocilizumab, a phase 2/3 US study evaluating efficacy and safety of sarilumab in patients hospitalized with severe COVID-19 was performed. At the moment, there are insufficient data to recommend either for or against use of sarilumab for hospitalized patients with COVID-19. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

sarilumab
REGN88
SAR153191
kevzara

Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Sarilumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis. Based on encouraging results in China with a similar drug, tocilizumab, a phase 2/3 US study evaluating efficacy and safety of sarilumab in patients hospitalized with severe COVID-19 was performed. At the moment, there are insufficient data to recommend either for or against use of sarilumab for hospitalized patients with COVID-19.

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

Drug dosage:

Dose	Unit	Route
14.30	mg	P

ADMET properties:

None

Approvals:

Show entries

Search:

Date	Agency	Company
June 23, 2017	EMA	sanofi-aventis groupe
May 22, 2017	FDA	SANOFI SYNTHELABO
Sept. 27, 2017	PMDA	SANOFI KK

Showing 1 to 3 of 3 entries

Previous1Next

FDA Adverse Event Reporting System (Female)

Show entries

Search:

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
Rheumatoid factor positive	1497.72	53.89	1049	76156	83357	63328460
Anti-cyclic citrullinated peptide antibody positive	1453.43	53.89	1171	76034	115041	63296776
Wound	1205.92	53.89	1223	75982	162040	63249777
Pericarditis	1188.35	53.89	1101	76104	130478	63281339
Hand deformity	1187.75	53.89	1200	76005	158257	63253560
Hepatic enzyme increased	1152.73	53.89	1321	75884	201007	63210810
Synovitis	1139.04	53.89	1264	75941	185654	63226163
Glossodynia	1106.00	53.89	1219	75986	177657	63234160
Pemphigus	1063.86	53.89	1210	75995	182516	63229301
Discomfort	1021.30	53.89	1133	76072	166241	63245576

Showing 1 to 10 of 166 entries

Previous1 2 3 4 5…17Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

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
Joint swelling	142.86	38.79	66	1666	59824	34895375
Pain	139.05	38.79	99	1633	204576	34750623
Drug ineffective	114.39	38.79	125	1607	456626	34498573
Arthralgia	107.71	38.79	79	1653	169962	34785237
Injection site pruritus	45.76	38.79	16	1716	6967	34948232
Product use in unapproved indication	45.21	38.79	41	1691	117458	34837741

Showing 1 to 6 of 6 entries

Previous1Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

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
Rheumatoid factor positive	1233.14	54.53	671	55373	59168	79629176
Anti-cyclic citrullinated peptide antibody positive	1221.75	54.53	748	55296	82395	79605949
Pemphigus	1170.25	54.53	778	55266	98804	79589540
Glossodynia	1153.60	54.53	782	55262	102555	79585789
Hand deformity	1147.23	54.53	781	55263	103138	79585206
Wound	1144.27	54.53	814	55230	115365	79572979
Systemic lupus erythematosus	1131.83	54.53	822	55222	120327	79568017
Pericarditis	1067.27	54.53	748	55296	103488	79584856
Synovitis	976.87	54.53	824	55220	149910	79538434
Discomfort	906.22	54.53	731	55313	124886	79563458

Showing 1 to 10 of 165 entries

Previous1 2 3 4 5…17Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	L04AC14	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors
FDA EPC	N0000190480	Interleukin-6 Receptor Antagonist
FDA MoA	N0000190478	Interleukin 6 Receptor Antagonists

Showing 1 to 3 of 3 entries

Previous1Next

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

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Rheumatoid arthritis	indication	69896004	DOID:7148
Bacterial infectious disease	contraindication	87628006

Showing 1 to 2 of 2 entries

Previous1Next

🐶 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:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Interleukin-6 receptor	Membrane receptor	P08887 P40189	IL6RA_HUMAN IL6RB_HUMAN	ANTIBODY BINDING	Kd	11.10		IUPHAR	DRUG LABEL

Showing 1 to 1 of 1 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
017137	NDDF
1923319	RXNORM
257686	MMSL
32766	MMSL
4036706	VANDF
735231009	SNOMEDCT_US
763522001	SNOMEDCT_US
7999	IUPHAR_LIGAND_ID
9476	INN_ID
C000592401	MESH_SUPPLEMENTAL_RECORD_UI

Showing 1 to 10 of 16 entries

Previous1 2Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
KEVZARA	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5908	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
KEVZARA	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5908	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
KEVZARA	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5910	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
KEVZARA	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5910	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
KEVZARA	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5920	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
KEVZARA	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5920	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
KEVZARA	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5922	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections
KEVZARA	HUMAN PRESCRIPTION DRUG LABEL	1	0024-5922	INJECTION, SOLUTION	200 mg	SUBCUTANEOUS	BLA	31 sections

Showing 1 to 8 of 8 entries

Previous1Next