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	1980.63	57.91	361	5285	4741	50594737
Bronchiolitis	1121.96	57.91	199	5447	2182	50597296
Respiratory syncytial virus bronchiolitis	645.98	57.91	94	5552	230	50599248
Respiratory syncytial virus test positive	596.78	57.91	80	5566	73	50599405
Pyrexia	236.16	57.91	248	5398	379955	50219523
Apnoea	223.86	57.91	65	5581	6901	50592577
Cough	166.49	57.91	167	5479	241097	50358381
Infantile spitting up	156.20	57.91	22	5624	38	50599440
Pneumonia	147.70	57.91	195	5451	378206	50221272
Cyanosis	141.86	57.91	56	5590	15128	50584350
Rhinovirus infection	140.70	57.91	39	5607	3495	50595983
Bronchitis	131.91	57.91	102	5544	104057	50495421
Pneumonia respiratory syncytial viral	127.06	57.91	26	5620	624	50598854
Death	116.51	57.91	161	5485	325218	50274260
Oxygen saturation decreased	97.60	57.91	74	5572	73174	50526304
Respiratory tract infection	93.74	57.91	53	5593	31964	50567514
Viral infection	88.76	57.91	50	5596	29936	50569542
Sudden infant death syndrome	88.32	57.91	16	5630	196	50599282
Cardiac operation	84.97	57.91	25	5621	2770	50596708
Weight gain poor	83.77	57.91	19	5627	748	50598730
Respiratory failure	83.38	57.91	74	5572	91107	50508371
Wheezing	81.12	57.91	62	5584	61985	50537493
Crying	79.92	57.91	41	5605	20375	50579103
Respiratory distress	74.76	57.91	45	5601	30444	50569034
Fluid intake reduced	65.47	57.91	21	5625	3101	50596377
Bronchopulmonary dysplasia	65.36	57.91	13	5633	269	50599209
Respiratory syncytial virus bronchitis	64.81	57.91	8	5638	0	50599478
Respiratory disorder	63.74	57.91	41	5605	31146	50568332
Nausea	63.28	57.91	4	5642	705394	49894084
COVID-19	61.78	57.91	47	5599	46615	50552863
Nasopharyngitis	60.70	57.91	90	5556	192837	50406641

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	2812.13	53.48	529	7478	3130	29563390
Bronchiolitis	1445.32	53.48	290	7717	2465	29564055
Respiratory syncytial virus test positive	599.07	53.48	96	7911	160	29566360
Respiratory syncytial virus bronchiolitis	515.86	53.48	89	7918	281	29566239
Apnoea	316.69	53.48	101	7906	6001	29560519
Bronchitis	264.97	53.48	149	7858	36719	29529801
Cough	223.41	53.48	219	7788	126508	29440012
Wheezing	182.60	53.48	113	7894	33127	29533393
Pyrexia	180.15	53.48	296	7711	287326	29279194
Cyanosis	178.23	53.48	78	7929	11189	29555331
Rhinovirus infection	174.07	53.48	55	7952	3161	29563359
Nasopharyngitis	155.97	53.48	129	7878	59536	29506984
Pneumonia	147.07	53.48	288	7719	319884	29246636
Crying	139.39	53.48	53	7954	5298	29561222
Pneumonia respiratory syncytial viral	132.18	53.48	33	7974	791	29565729
Viral infection	128.76	53.48	68	7939	14742	29551778
Rhinorrhoea	125.33	53.48	76	7931	21443	29545077
Oxygen saturation decreased	119.09	53.48	98	7909	44839	29521681
Respiratory tract infection	116.95	53.48	65	7942	15586	29550934
Infantile spitting up	112.24	53.48	18	7989	30	29566490
Influenza	110.26	53.48	91	7916	41790	29524730
Respiratory syncytial virus bronchitis	109.65	53.48	16	7991	7	29566513
Respiratory disorder	109.35	53.48	64	7943	16919	29549601
Sudden infant death syndrome	106.34	53.48	21	7986	160	29566360
Respiratory distress	102.15	53.48	78	7929	32028	29534492
Cardiac operation	98.15	53.48	34	7973	2602	29563918
Pallor	80.18	53.48	57	7950	20967	29545553
COVID-19	74.03	53.48	68	7939	35946	29530574
Inguinal hernia	73.52	53.48	36	7971	6652	29559868
Fluid intake reduced	72.70	53.48	28	7979	2894	29563626
Rotavirus infection	71.19	53.48	17	7990	336	29566184
Ill-defined disorder	69.89	53.48	42	7965	11636	29554884
Inappropriate schedule of product administration	61.96	53.48	68	7939	44404	29522116
Dyspnoea	60.08	53.48	209	7798	326523	29239997
Nausea	59.89	53.48	5	8002	289250	29277270
Poor feeding infant	57.20	53.48	15	7992	439	29566081
Bronchopulmonary dysplasia	55.07	53.48	15	7992	509	29566011
Febrile convulsion	54.49	53.48	15	7992	530	29565990
Nasal congestion	53.78	53.48	43	7964	18836	29547684
Croup infectious	53.69	53.48	13	7994	273	29566247

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	2672.73	52.59	483	6000	6785	64485464
Bronchiolitis	1794.62	52.59	311	6172	3330	64488919
Respiratory syncytial virus bronchiolitis	783.02	52.59	115	6368	354	64491895
Respiratory syncytial virus test positive	703.77	52.59	100	6383	224	64492025
Bronchitis	282.04	52.59	160	6323	108583	64383666
Apnoea	180.14	52.59	59	6424	10363	64481886
Pneumonia respiratory syncytial viral	179.76	52.59	39	6444	1392	64490857
Respiratory syncytial virus bronchitis	150.72	52.59	19	6464	6	64492243
Sudden infant death syndrome	149.86	52.59	24	6459	147	64492102
Pneumonia	139.80	52.59	221	6262	559355	63932894
Pyrexia	127.71	52.59	212	6271	558432	63933817
Rhinovirus infection	123.33	52.59	39	6444	6117	64486132
Bronchopulmonary dysplasia	120.32	52.59	20	6463	159	64492090
Respiratory failure	117.58	52.59	110	6373	161073	64331176
Cyanosis	117.42	52.59	53	6430	22102	64470147
Wheezing	109.43	52.59	79	6404	80500	64411749
Cough	105.25	52.59	140	6343	302008	64190241
Respiratory distress	91.55	52.59	60	6423	52271	64439978
Gastroenteritis	91.24	52.59	49	6434	29662	64462587
Respiratory disorder	90.24	52.59	52	6431	36059	64456190
Viral infection	79.69	52.59	48	6435	36092	64456157
Cardiac operation	73.36	52.59	24	6459	4190	64488059
Rhinitis	70.82	52.59	30	6453	10735	64481514
Oxygen saturation decreased	68.32	52.59	68	6415	107108	64385141
Rhinorrhoea	66.25	52.59	52	6431	59917	64432332
Respiratory tract infection	63.23	52.59	42	6441	37365	64454884
Poor feeding infant	62.07	52.59	11	6472	132	64492117
Asthma	61.75	52.59	61	6422	95164	64397085
Febrile convulsion	58.07	52.59	14	6469	801	64491448
Death	57.53	52.59	140	6343	482565	64009684
Gastroenteritis rotavirus	56.38	52.59	12	6471	390	64491859

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 (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
7753	INN_ID
DB00110	DRUGBANK_ID
DQ448MW7KS	UNII
194279	RXNORM
11748	MMSL
7481	MMSL
d04323	MMSL
108725001	SNOMEDCT_US
386900007	SNOMEDCT_US
D000069455	MESH_DESCRIPTOR_UI
C0672596	UMLSCUI
007619	NDDF

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