Stem definition | Drug id | CAS RN |
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primate origin | 5453 | 2423943-37-5 |
Molecule | Description |
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Synonyms:
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Effective April 16, 2021, FDA revoked the EUA for use of bamlanivimab alone (monotherapy) for the treatment of mild to moderate COVID-19. The EUA for use of bamlanivimab in a combined regimen with etesevimab remains unchanged. Bamlanivimab is a recombinant neutralizing human IgG1kappa monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region. Bamlanivimab binds to spike protein and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.025 μg/mL.
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Date | Agency | Company | Orphan |
---|---|---|---|
Nov. 11, 2020 | FDA | Eli Lilly and Company |
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 |
---|---|---|---|---|---|---|
Infusion related reaction | 619.18 | 46.67 | 334 | 5115 | 245187 | 63238386 |
COVID-19 pneumonia | 437.83 | 46.67 | 121 | 5328 | 14088 | 63469485 |
Oxygen saturation decreased | 387.22 | 46.67 | 176 | 5273 | 88409 | 63395164 |
Dyspnoea | 385.82 | 46.67 | 368 | 5081 | 660945 | 62822628 |
Hypoxia | 264.60 | 46.67 | 120 | 5329 | 59672 | 63423901 |
Flushing | 229.75 | 46.67 | 117 | 5332 | 74970 | 63408603 |
Chest discomfort | 200.84 | 46.67 | 122 | 5327 | 109847 | 63373726 |
Chills | 134.17 | 46.67 | 96 | 5353 | 113282 | 63370291 |
Pyrexia | 119.25 | 46.67 | 172 | 5277 | 470306 | 63013267 |
Chest pain | 94.58 | 46.67 | 104 | 5345 | 215855 | 63267718 |
Cough | 82.74 | 46.67 | 113 | 5336 | 292630 | 63190943 |
Dizziness | 67.63 | 46.67 | 127 | 5322 | 429798 | 63053775 |
Drug ineffective | 56.16 | 46.67 | 11 | 5438 | 1044754 | 62438819 |
Nausea | 50.62 | 46.67 | 174 | 5275 | 854297 | 62629276 |
Fibrin D dimer increased | 49.59 | 46.67 | 18 | 5431 | 5016 | 63478557 |
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 |
---|---|---|---|---|---|---|
Infusion related reaction | 621.47 | 43.42 | 253 | 5302 | 52804 | 34898572 |
Oxygen saturation decreased | 513.65 | 43.42 | 222 | 5333 | 53596 | 34897780 |
COVID-19 pneumonia | 494.17 | 43.42 | 159 | 5396 | 16808 | 34934568 |
Hypoxia | 366.49 | 43.42 | 177 | 5378 | 54918 | 34896458 |
Dyspnoea | 301.64 | 43.42 | 331 | 5224 | 376451 | 34574925 |
Chills | 299.53 | 43.42 | 176 | 5379 | 80867 | 34870509 |
Pyrexia | 183.65 | 43.42 | 243 | 5312 | 332770 | 34618606 |
Cough | 106.81 | 43.42 | 125 | 5430 | 150015 | 34801361 |
Flushing | 87.83 | 43.42 | 58 | 5497 | 32362 | 34919014 |
Tachycardia | 81.83 | 43.42 | 83 | 5472 | 84689 | 34866687 |
Acute respiratory failure | 80.56 | 43.42 | 54 | 5501 | 30874 | 34920502 |
Body temperature increased | 77.98 | 43.42 | 43 | 5512 | 17325 | 34934051 |
Respiratory failure | 66.61 | 43.42 | 84 | 5471 | 108488 | 34842888 |
Fibrin D dimer increased | 66.05 | 43.42 | 25 | 5530 | 4219 | 34947157 |
Chest discomfort | 61.15 | 43.42 | 58 | 5497 | 54472 | 34896904 |
Hyperhidrosis | 56.95 | 43.42 | 65 | 5490 | 75627 | 34875749 |
Chest pain | 56.46 | 43.42 | 84 | 5471 | 126678 | 34824698 |
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 |
---|---|---|---|---|---|---|
Infusion related reaction | 1146.44 | 38.76 | 578 | 10386 | 229659 | 79503765 |
COVID-19 pneumonia | 847.15 | 38.76 | 263 | 10701 | 28586 | 79704838 |
Oxygen saturation decreased | 823.73 | 38.76 | 385 | 10579 | 128662 | 79604762 |
Dyspnoea | 664.55 | 38.76 | 691 | 10273 | 856334 | 78877090 |
Hypoxia | 596.55 | 38.76 | 288 | 10676 | 102955 | 79630469 |
Chills | 421.40 | 38.76 | 266 | 10698 | 159968 | 79573456 |
Flushing | 313.44 | 38.76 | 178 | 10786 | 88090 | 79645334 |
Pyrexia | 276.91 | 38.76 | 398 | 10566 | 678311 | 79055113 |
Chest discomfort | 229.39 | 38.76 | 173 | 10791 | 137871 | 79595553 |
Cough | 180.22 | 38.76 | 236 | 10728 | 366553 | 79366871 |
Chest pain | 137.43 | 38.76 | 181 | 10783 | 282123 | 79451301 |
Acute respiratory failure | 113.08 | 38.76 | 81 | 10883 | 59460 | 79673964 |
Tachycardia | 112.22 | 38.76 | 130 | 10834 | 177638 | 79555786 |
Fibrin D dimer increased | 108.95 | 38.76 | 42 | 10922 | 8612 | 79724812 |
Body temperature increased | 107.03 | 38.76 | 70 | 10894 | 44350 | 79689074 |
Respiratory failure | 105.41 | 38.76 | 127 | 10837 | 180784 | 79552640 |
Hyperhidrosis | 90.92 | 38.76 | 108 | 10856 | 151384 | 79582040 |
Tachypnoea | 83.32 | 38.76 | 53 | 10911 | 32010 | 79701414 |
Drug ineffective | 79.76 | 38.76 | 25 | 10939 | 1080888 | 78652536 |
Dizziness | 70.33 | 38.76 | 194 | 10770 | 526247 | 79207177 |
Nausea | 64.02 | 38.76 | 280 | 10684 | 956916 | 78776508 |
Lung opacity | 57.68 | 38.76 | 23 | 10941 | 5151 | 79728273 |
Troponin increased | 55.49 | 38.76 | 34 | 10930 | 19221 | 79714203 |
Off label use | 50.98 | 38.76 | 31 | 10933 | 907184 | 78826240 |
Blood pressure decreased | 50.12 | 38.76 | 65 | 10899 | 99401 | 79634023 |
Mental status changes | 47.32 | 38.76 | 52 | 10912 | 66907 | 79666517 |
Feeling hot | 46.81 | 38.76 | 49 | 10915 | 59685 | 79673739 |
Wrong product administered | 45.45 | 38.76 | 23 | 10941 | 8989 | 79724435 |
Drug interaction | 45.38 | 38.76 | 3 | 10961 | 415180 | 79318244 |
Lung infiltration | 40.80 | 38.76 | 30 | 10934 | 22882 | 79710542 |
Tremor | 40.70 | 38.76 | 79 | 10885 | 170004 | 79563420 |
Hypotension | 39.05 | 38.76 | 141 | 10823 | 440176 | 79293248 |
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Source | Code | Description |
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MeSH PA | D000890 | Anti-Infective Agents |
MeSH PA | D000998 | Antiviral Agents |
Disease | Relation | SNOMED_ID | DOID |
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COVID-19 | indication | 840539006 |
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Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Spike glycoprotein | Glycoprotein | Kd | 10.15 | DRUG LABEL | DRUG LABEL |
ID | Source |
---|---|
D11936 | KEGG_DRUG |
45I6OFJ8QH | UNII |
C5421805 | UMLSCUI |
CHEMBL4650379 | ChEMBL_ID |
DB15718 | DRUGBANK_ID |
11325 | IUPHAR_LIGAND_ID |
018553 | NDDF |
1119335003 | SNOMEDCT_US |
1119336002 | SNOMEDCT_US |
4039827 | VANDF |
2463114 | RXNORM |
340769 | MMSL |
39004 | MMSL |
d09678 | MMSL |
C000711749 | MESH_SUPPLEMENTAL_RECORD_UI |
11876 | INN_ID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Bamlanivimab | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-7910 | INJECTION, SOLUTION | 35 mg | INTRAVENOUS | Emergency Use Authorization | 29 sections |
Bamlanivimab | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-7910 | INJECTION, SOLUTION | 35 mg | INTRAVENOUS | Emergency Use Authorization | 29 sections |