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

Stem definitionDrug idCAS RN
humanized origin 4935 188039-54-5

Description:

MoleculeDescription

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:

DateAgencyCompanyOrphan
Aug. 13, 1999 EMA
June 19, 1998 FDA MEDIMMUNE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Fusion glycoprotein F0 Surface antigen ANTIBODY BINDING EC50 5.36 DRUG LABEL DRUG LABEL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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