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

Stem definition	Drug id	CAS RN
humanized origin	4935	188039-54-5

Description:

Molecule	Description
Synonyms: palivizumab synagis MEDI-493	A humanized monoclonal antibody and ANTIVIRAL AGENT that is used to prevent RESPIRATORY SYNCYTIAL VIRUS INFECTIONS in high risk pediatric patients. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

palivizumab
synagis
MEDI-493

A humanized monoclonal antibody and ANTIVIRAL AGENT that is used to prevent RESPIRATORY SYNCYTIAL VIRUS INFECTIONS in high risk pediatric patients.

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Aug. 13, 1999	EMA
June 19, 1998	FDA	MEDIMMUNE

FDA Adverse Event Reporting System (Female)

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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
Respiratory syncytial virus infection	2263.14	58.17	416	5809	6602	63476195
Bronchiolitis	1245.91	58.17	218	6007	2529	63480268
Respiratory syncytial virus bronchiolitis	686.90	58.17	98	6127	237	63482560
Respiratory syncytial virus test positive	623.67	58.17	83	6142	88	63482709
Pyrexia	250.13	58.17	266	5959	470212	63012585
Apnoea	231.94	58.17	67	6158	7955	63474842
Rhinovirus infection	186.83	58.17	50	6175	4479	63478318
Death	172.81	58.17	197	6028	374184	63108613
Cough	171.81	58.17	175	6050	292568	63190229
Infantile spitting up	150.12	58.17	22	6203	68	63482729

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FDA Adverse Event Reporting System (Male)

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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
Respiratory syncytial virus infection	3257.37	52.87	617	8295	4092	34943927
Bronchiolitis	1528.06	52.87	308	8604	2868	34945151
Respiratory syncytial virus test positive	608.73	52.87	97	8815	168	34947851
Respiratory syncytial virus bronchiolitis	538.90	52.87	94	8818	348	34947671
Apnoea	330.32	52.87	105	8807	6559	34941460
Bronchitis	279.34	52.87	158	8754	41805	34906214
Rhinovirus infection	243.34	52.87	75	8837	4224	34943795
Cough	239.32	52.87	239	8673	149901	34798118
Pyrexia	200.83	52.87	326	8586	332687	34615332
Cyanosis	195.96	52.87	85	8827	12679	34935340

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FDA Adverse Event Reporting System (Geriatric)

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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
Respiratory syncytial virus infection	2799.18	49.19	511	6418	8891	79728568
Bronchiolitis	1864.03	49.19	321	6608	3867	79733592
Respiratory syncytial virus bronchiolitis	810.52	49.19	117	6812	373	79737086
Respiratory syncytial virus test positive	743.39	49.19	104	6825	245	79737214
Bronchitis	281.64	49.19	162	6767	130482	79606977
Pneumonia respiratory syncytial viral	185.61	49.19	41	6888	1849	79735610
Apnoea	181.84	49.19	59	6870	11645	79725814
Rhinovirus infection	156.41	49.19	48	6881	7905	79729554
Respiratory syncytial virus bronchitis	153.48	49.19	19	6910	6	79737453
Pneumonia	141.92	49.19	225	6704	660021	79077438

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J06BD01	ANTIINFECTIVES FOR SYSTEMIC USE IMMUNE SERA AND IMMUNOGLOBULINS IMMUNOGLOBULINS Antiviral monoclonal antibodies
FDA CS	M0001357	Antibodies, Monoclonal
FDA EPC	N0000175623	Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
FDA MoA	N0000175615	Fusion Protein Inhibitors
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000998	Antiviral Agents

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

Disease	Relation	SNOMED_ID	DOID
Respiratory syncytial virus infection	indication	55735004	DOID:1273

🐶 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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Fusion glycoprotein F0	Surface antigen		FUS_HRSVA	ANTIBODY BINDING	EC50	5.36		DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
007619	NDDF
108725001	SNOMEDCT_US
11748	MMSL
194279	RXNORM
386900007	SNOMEDCT_US
4021116	VUID
4021116	VANDF
7481	MMSL
7753	INN_ID
C0672596	UMLSCUI

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Synagis	HUMAN PRESCRIPTION DRUG LABEL	1	60574-4113	INJECTION, SOLUTION	100 mg	INTRAMUSCULAR	BLA	25 sections
Synagis	HUMAN PRESCRIPTION DRUG LABEL	1	60574-4114	INJECTION, SOLUTION	50 mg	INTRAMUSCULAR	BLA	25 sections
Synagis	HUMAN PRESCRIPTION DRUG LABEL	1	66658-230	INJECTION, SOLUTION	50 mg	INTRAMUSCULAR	BLA	26 sections
Synagis	HUMAN PRESCRIPTION DRUG LABEL	1	66658-230	INJECTION, SOLUTION	50 mg	INTRAMUSCULAR	BLA	26 sections
Synagis	HUMAN PRESCRIPTION DRUG LABEL	1	66658-231	INJECTION, SOLUTION	100 mg	INTRAMUSCULAR	BLA	26 sections
Synagis	HUMAN PRESCRIPTION DRUG LABEL	1	66658-231	INJECTION, SOLUTION	100 mg	INTRAMUSCULAR	BLA	26 sections

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