palivizumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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 2420.51 57.05 448 6206 10032 90611761
Bronchiolitis 1288.69 57.05 222 6432 3190 90618603
Respiratory syncytial virus bronchiolitis 715.64 57.05 101 6553 326 90621467
Respiratory syncytial virus test positive 524.48 57.05 87 6567 971 90620822
Pyrexia 277.97 57.05 288 6366 660197 89961596
Apnoea 258.94 57.05 71 6583 9343 90612450
Rhinovirus infection 216.35 57.05 56 6598 5907 90615886
Death 203.83 57.05 206 6448 456345 90165448
Cough 201.36 57.05 186 6468 368776 90253017
Infantile spitting up 169.32 57.05 24 6630 80 90621713
Cyanosis 162.22 57.05 59 6595 19396 90602397
Pneumonia 155.45 57.05 211 6443 637848 89983945
Bronchitis 152.99 57.05 110 6544 152817 90468976
Illness 133.41 57.05 80 6574 81889 90539904
Pneumonia respiratory syncytial viral 130.16 57.05 28 6626 1323 90620470
Oxygen saturation decreased 118.26 57.05 82 6572 107401 90514392
Respiratory distress 113.66 57.05 56 6598 38890 90582903
Viral infection 110.40 57.05 56 6598 41358 90580435
Weight gain poor 105.66 57.05 23 6631 1149 90620644
Respiratory failure 104.40 57.05 79 6575 118339 90503454
Respiratory tract infection 102.19 57.05 60 6594 59018 90562775
Product dose omission issue 100.37 57.05 115 6539 291572 90330221
Crying 93.53 57.05 43 6611 25602 90596191
Cardiac operation 86.76 57.05 25 6629 3924 90617869
Sudden infant death syndrome 81.29 57.05 15 6639 319 90621474
Influenza 77.09 57.05 71 6583 139193 90482600
Cardiac disorder 73.53 57.05 48 6606 56824 90564969
Fluid intake reduced 72.48 57.05 22 6632 4130 90617663
Increased bronchial secretion 72.18 57.05 19 6635 2134 90619659
COVID-19 69.11 57.05 73 6581 168770 90453023
Respiratory disorder 67.84 57.05 48 6606 64768 90557025
Nasopharyngitis 66.35 57.05 112 6542 406992 90214801
Hypophagia 66.09 57.05 38 6616 35899 90585894
Nausea 65.92 57.05 4 6650 1110312 89511481
Selective eating disorder 63.51 57.05 17 6637 2036 90619757
Febrile convulsion 61.70 57.05 13 6641 555 90621238
Bronchopulmonary dysplasia 60.48 57.05 13 6641 611 90621182
Respiratory syncytial virus bronchitis 57.86 57.05 8 6646 21 90621772

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 3351.67 50.68 662 8874 6490 42605309
Bronchiolitis 1628.83 50.68 329 9207 3577 42608222
Respiratory syncytial virus test positive 627.29 50.68 105 9431 337 42611462
Respiratory syncytial virus bronchiolitis 546.10 50.68 99 9437 560 42611239
Apnoea 331.58 50.68 106 9430 7697 42604102
Bronchitis 292.11 50.68 162 9374 47039 42564760
Cough 255.01 50.68 252 9284 177851 42433948
Rhinovirus infection 249.84 50.68 82 9454 6466 42605333
Illness 233.16 50.68 113 9423 24817 42586982
Pyrexia 225.80 50.68 351 9185 393691 42218108
Cyanosis 212.89 50.68 91 9445 14940 42596859
Nasopharyngitis 187.58 50.68 153 9383 83843 42527956
Wheezing 173.56 50.68 123 9413 54658 42557141
Viral infection 166.37 50.68 87 9449 22396 42589403
Pneumonia 162.69 50.68 316 9220 421833 42189966
Crying 158.34 50.68 58 9478 6336 42605463
Influenza 144.49 50.68 116 9420 62059 42549740
Pneumonia respiratory syncytial viral 143.82 50.68 38 9498 1396 42610403
Respiratory tract infection 142.80 50.68 83 9453 26239 42585560
Oxygen saturation decreased 138.36 50.68 115 9421 64572 42547227
Respiratory distress 130.30 50.68 93 9443 41727 42570072
Respiratory disorder 128.76 50.68 73 9463 22012 42589787
Rhinorrhoea 128.34 50.68 83 9453 31711 42580088
Infantile spitting up 114.90 50.68 19 9517 55 42611744
Respiratory syncytial virus bronchitis 107.90 50.68 19 9517 88 42611711
Cardiac operation 104.54 50.68 37 9499 3658 42608141
Inguinal hernia 103.62 50.68 47 9489 8865 42602934
Product dose omission issue 99.66 50.68 146 9390 154219 42457580
Sudden infant death syndrome 98.40 50.68 21 9515 299 42611500
Fluid intake reduced 86.74 50.68 33 9503 3999 42607800
Inappropriate schedule of product administration 85.16 50.68 106 9430 95796 42516003
Pallor 82.55 50.68 61 9475 28825 42582974
Rotavirus infection 72.81 50.68 18 9518 504 42611295
Ill-defined disorder 71.82 50.68 45 9491 16251 42595548
Nausea 69.77 50.68 5 9531 396794 42215005
COVID-19 68.07 50.68 105 9431 115843 42495956
Croup infectious 67.39 50.68 17 9519 518 42611281
Vomiting 66.29 50.68 177 9359 289546 42322253
Dyspnoea 64.61 50.68 231 9305 442390 42169409
Ear infection 60.59 50.68 37 9499 12767 42599032
Nasal congestion 59.98 50.68 51 9485 29450 42582349
Febrile convulsion 57.99 50.68 16 9520 693 42611106
Bronchopulmonary dysplasia 56.96 50.68 16 9520 741 42611058
Respiratory failure 52.62 50.68 99 9437 128033 42483766
Enterovirus infection 52.55 50.68 17 9519 1276 42610523
Oligodipsia 51.92 50.68 8 9528 12 42611787
Hypophagia 51.55 50.68 45 9491 26911 42584888
Poor feeding infant 50.86 50.68 15 9521 827 42610972

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 3065.08 48.89 570 7126 13914 110567689
Bronchiolitis 1956.30 48.89 337 7359 5156 110576447
Respiratory syncytial virus bronchiolitis 829.10 48.89 123 7573 652 110580951
Respiratory syncytial virus test positive 691.96 48.89 115 7581 1379 110580224
Bronchitis 295.40 48.89 165 7531 156867 110424736
Apnoea 206.72 48.89 64 7632 13575 110568028
Pneumonia respiratory syncytial viral 190.16 48.89 43 7653 2706 110578897
Rhinovirus infection 181.52 48.89 56 7640 11733 110569870
Pyrexia 178.59 48.89 262 7434 898003 109683600
Pneumonia 157.43 48.89 244 7452 876470 109705133
Cyanosis 151.09 48.89 62 7634 29679 110551924
Respiratory syncytial virus bronchitis 142.04 48.89 19 7677 38 110581565
Cough 139.93 48.89 166 7530 461475 110120128
Respiratory failure 135.00 48.89 115 7581 215217 110366386
Sudden infant death syndrome 134.69 48.89 23 7673 326 110581277
Bronchopulmonary dysplasia 125.68 48.89 21 7675 259 110581344
Respiratory distress 125.46 48.89 71 7625 68803 110512800
Viral infection 105.54 48.89 58 7638 53081 110528522
Gastroenteritis 98.78 48.89 50 7646 38750 110542853
Death 98.76 48.89 175 7521 698694 109882909
Oxygen saturation decreased 96.57 48.89 83 7613 156899 110424704
Respiratory disorder 92.16 48.89 59 7637 71323 110510280
Cardiac operation 81.90 48.89 26 7670 5969 110575634
Illness 79.95 48.89 57 7639 82114 110499489
Respiratory tract infection 79.81 48.89 54 7642 71563 110510040
Seizure 72.54 48.89 83 7613 221102 110360501
Wheezing 72.53 48.89 89 7607 255141 110326462
Inguinal hernia 71.57 48.89 25 7671 7700 110573903
Febrile convulsion 69.43 48.89 16 7680 1094 110580509
Poor feeding infant 68.96 48.89 12 7684 191 110581412
Rhinorrhoea 68.68 48.89 57 7639 102609 110478994
Crying 68.08 48.89 34 7662 25594 110556009
Irritability 62.89 48.89 40 7656 47769 110533834
Rhinitis 60.15 48.89 30 7666 22515 110559088
Subglottic laryngitis 60.14 48.89 8 7688 15 110581588
Pallor 59.17 48.89 41 7655 56426 110525177
Fatigue 58.13 48.89 8 7688 1215950 109365653
Vomiting 56.94 48.89 165 7531 910510 109671093
Gastroenteritis rotavirus 55.82 48.89 12 7684 596 110581007
Influenza 52.96 48.89 62 7634 169039 110412564
Selective eating disorder 51.65 48.89 10 7686 293 110581310
Feeding disorder 49.93 48.89 26 7670 21336 110560267

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
CHEBI has role CHEBI:22587 antiviral agent

Related Drugs by ATC class:

J06BD Antiviral monoclonal antibodies 10 drugs
ansuvimabcasirivimabcilgavimabclesrovimabimdevimabnirsevimabregdanvimabsipavibartsotrovimabtixagevimab

Drug Use | Suggest Off label Use Form| |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
CHEBI:749496 CHEBI
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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