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)

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
Cyanosis	150.01	58.17	58	6167	16877	63465920
Pneumonia	146.04	58.17	200	6025	456567	63026230
Bronchitis	142.26	58.17	109	6116	124826	63357971
Pneumonia respiratory syncytial viral	117.98	58.17	26	6199	1024	63481773
Illness	106.73	58.17	64	6161	48995	63433802
Viral infection	103.04	58.17	56	6169	35607	63447190
Respiratory distress	102.80	58.17	55	6170	33896	63448901
Oxygen saturation decreased	100.09	58.17	77	6148	88508	63394289
Weight gain poor	99.15	58.17	22	6203	894	63481903
Respiratory failure	92.68	58.17	78	6147	101780	63381017
Respiratory tract infection	89.91	58.17	54	6171	41429	63441368
Sudden infant death syndrome	84.36	58.17	16	6209	293	63482504
Cardiac operation	84.07	58.17	25	6200	3273	63479524
Crying	82.62	58.17	42	6183	23301	63459496
Product dose omission issue	79.61	58.17	106	6119	234207	63248590
Wheezing	70.50	58.17	65	6160	95530	63387267
Nausea	68.13	58.17	4	6221	854467	62628330
Respiratory disorder	67.36	58.17	44	6181	39038	63443759
Nasopharyngitis	67.12	58.17	102	6123	254155	63228642
COVID-19	66.67	58.17	68	6157	113035	63369762
Respiratory syncytial virus bronchitis	65.85	58.17	8	6217	0	63482797
Fluid intake reduced	64.96	58.17	21	6204	3620	63479177
Bronchopulmonary dysplasia	61.47	58.17	13	6212	420	63482377
Influenza	59.81	58.17	63	6162	108659	63374138
Selective eating disorder	58.49	58.17	17	6208	2055	63480742

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
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
Wheezing	187.84	52.87	122	8790	41280	34906739
Illness	181.62	52.87	82	8830	13447	34934572
Nasopharyngitis	175.48	52.87	144	8768	69824	34878195
Pneumonia	146.85	52.87	299	8613	362328	34585691
Viral infection	146.57	52.87	77	8835	17546	34930473
Pneumonia respiratory syncytial viral	145.40	52.87	36	8876	887	34947132
Influenza	145.37	52.87	112	8800	49554	34898465
Crying	144.96	52.87	55	8857	5807	34942212
Rhinorrhoea	132.18	52.87	82	8830	25586	34922433
Respiratory syncytial virus bronchitis	125.05	52.87	18	8894	7	34948012
Respiratory disorder	123.81	52.87	71	8841	19193	34928826
Respiratory distress	121.19	52.87	88	8824	35577	34912442
Respiratory tract infection	119.64	52.87	70	8842	19642	34928377
Infantile spitting up	117.05	52.87	19	8893	39	34947980
Oxygen saturation decreased	116.78	52.87	102	8810	53716	34894303
Product dose omission issue	101.40	52.87	138	8774	119573	34828446
Sudden infant death syndrome	101.01	52.87	21	8891	227	34947792
Cardiac operation	98.45	52.87	35	8877	3072	34944947
Inappropriate schedule of product administration	91.16	52.87	95	8817	62201	34885818
COVID-19	83.87	52.87	101	8811	77449	34870570
Fluid intake reduced	78.25	52.87	31	8881	3670	34944349
Pallor	77.83	52.87	59	8853	25421	34922598
Rotavirus infection	75.02	52.87	18	8894	387	34947632
Inguinal hernia	71.02	52.87	36	8876	7605	34940414
Ill-defined disorder	67.94	52.87	43	8869	13866	34934153
Nausea	67.77	52.87	5	8907	339903	34608116
Vomiting	61.18	52.87	169	8743	247452	34700567
Dyspnoea	59.24	52.87	220	8692	376562	34571457
Nasal congestion	58.78	52.87	48	8864	23009	34925010
Ear infection	58.55	52.87	35	8877	10196	34937823
Febrile convulsion	57.87	52.87	16	8896	611	34947408
Poor feeding infant	55.60	52.87	15	8897	522	34947497
Croup infectious	55.41	52.87	14	8898	375	34947644
Bronchopulmonary dysplasia	54.00	52.87	15	8897	583	34947436

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
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
Sudden infant death syndrome	141.10	49.19	24	6905	261	79737198
Pyrexia	138.64	49.19	226	6703	678483	79058976
Cyanosis	134.50	49.19	58	6871	25124	79712335
Respiratory failure	124.32	49.19	112	6817	180799	79556660
Bronchopulmonary dysplasia	116.47	49.19	20	6909	231	79737228
Cough	110.56	49.19	147	6782	366642	79370817
Respiratory distress	108.73	49.19	66	6863	58273	79679186
Wheezing	106.29	49.19	85	6844	116579	79620880
Respiratory disorder	100.02	49.19	57	6872	44799	79692660
Gastroenteritis	94.44	49.19	50	6879	34032	79703427
Viral infection	88.81	49.19	52	6877	42964	79694495
Death	79.93	49.19	161	6768	566353	79171106
Cardiac operation	76.73	49.19	25	6904	4987	79732472
Rhinorrhoea	70.45	49.19	56	6873	76018	79661441
Oxygen saturation decreased	67.83	49.19	69	6860	128978	79608481
Rhinitis	65.82	49.19	30	6899	14777	79722682
Respiratory tract infection	65.75	49.19	45	6884	48644	79688815
Febrile convulsion	63.20	49.19	15	6914	931	79736528
Poor feeding infant	61.08	49.19	11	6918	170	79737289
Gastroenteritis rotavirus	57.57	49.19	12	6917	409	79737050
Fatigue	57.06	49.19	7	6922	929720	78807739
Crying	53.27	49.19	30	6899	23013	79714446
Vomiting	52.35	49.19	151	6778	665677	79071782
Asthma	51.44	49.19	61	6868	135034	79602425
Subglottic laryngitis	50.11	49.19	6	6923	0	79737459
Seizure	49.63	49.19	71	6858	188763	79548696
Selective eating disorder	49.20	49.19	10	6919	300	79737159

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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:

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

External reference:

ID	Source
D02737	KEGG_DRUG
4021116	VUID
N0000148570	NUI
4021116	VANDF
CHEMBL1201586	ChEMBL_ID
DB00110	DRUGBANK_ID
194279	RXNORM
11748	MMSL
7481	MMSL
d04323	MMSL
007619	NDDF
108725001	SNOMEDCT_US
386900007	SNOMEDCT_US
C0672596	UMLSCUI
D000069455	MESH_DESCRIPTOR_UI
7753	INN_ID
DQ448MW7KS	UNII

Pharmaceutical products:

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