Stem definition | Drug id | CAS RN |
---|---|---|
humanized origin | 4935 | 188039-54-5 |
Molecule | Description |
---|---|
Synonyms:
|
A humanized monoclonal antibody and ANTIVIRAL AGENT that is used to prevent RESPIRATORY SYNCYTIAL VIRUS INFECTIONS in high risk pediatric patients.
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None
None
Date | Agency | Company | Orphan |
---|---|---|---|
Aug. 13, 1999 | EMA | ||
June 19, 1998 | FDA | MEDIMMUNE |
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 |
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 |
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 |
None
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 |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Respiratory syncytial virus infection | indication | 55735004 | DOID:1273 |
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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 | ANTIBODY BINDING | EC50 | 5.36 | DRUG LABEL | DRUG LABEL |
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 |
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 |