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| Stem definition | Drug id | CAS RN |
|---|---|---|
| humanized origin | 5072 | 915296-00-3 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
a humanized monoclonal antibody that selectively targets glycoproteins expressed on myeloma cells
|
| Dose | Unit | Route |
|---|---|---|
| 50 | mg | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 28, 2016 | PMDA | Bristol-Myers Squibb | |
| May 11, 2016 | EMA | Bristol-Myers Squibb | |
| Nov. 30, 2015 | FDA | BRISTOL MYERS SQUIBB |
| 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 219.81 | 24.78 | 98 | 3329 | 106772 | 90518248 |
| Plasma cell myeloma | 214.68 | 24.78 | 74 | 3353 | 40754 | 90584266 |
| Neutropenia | 74.13 | 24.78 | 64 | 3363 | 224840 | 90400180 |
| Platelet count decreased | 68.84 | 24.78 | 50 | 3377 | 136919 | 90488101 |
| Pneumonia | 61.47 | 24.78 | 96 | 3331 | 637963 | 89987057 |
| Cytomegalovirus infection | 53.22 | 24.78 | 24 | 3403 | 26578 | 90598442 |
| Paraproteinaemia | 52.50 | 24.78 | 9 | 3418 | 248 | 90624772 |
| Death | 51.44 | 24.78 | 74 | 3353 | 456477 | 90168543 |
| Plasma cell myeloma recurrent | 48.80 | 24.78 | 14 | 3413 | 4214 | 90620806 |
| Thrombocytopenia | 48.61 | 24.78 | 49 | 3378 | 208676 | 90416344 |
| Anaemia | 48.50 | 24.78 | 63 | 3364 | 352739 | 90272281 |
| Lymphocyte count decreased | 46.91 | 24.78 | 24 | 3403 | 35026 | 90589994 |
| Pyrexia | 45.86 | 24.78 | 86 | 3341 | 660399 | 89964621 |
| Neutrophil count decreased | 45.00 | 24.78 | 30 | 3397 | 71502 | 90553518 |
| Febrile infection | 43.50 | 24.78 | 11 | 3416 | 2058 | 90622962 |
| Pneumococcal sepsis | 41.07 | 24.78 | 9 | 3418 | 909 | 90624111 |
| Pneumonia pneumococcal | 35.95 | 24.78 | 10 | 3417 | 2692 | 90622328 |
| Diarrhoea | 33.52 | 24.78 | 94 | 3333 | 939096 | 89685924 |
| Neuropathy peripheral | 31.56 | 24.78 | 32 | 3395 | 136938 | 90488082 |
| Febrile neutropenia | 29.42 | 24.78 | 33 | 3394 | 158316 | 90466704 |
| Toxic shock syndrome | 29.29 | 24.78 | 7 | 3420 | 1037 | 90623983 |
| Cytomegalovirus infection reactivation | 29.12 | 24.78 | 11 | 3416 | 7789 | 90617231 |
| Sepsis | 27.63 | 24.78 | 34 | 3393 | 179780 | 90445240 |
| Beta haemolytic streptococcal infection | 27.55 | 24.78 | 8 | 3419 | 2511 | 90622509 |
| 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 140.41 | 25.10 | 104 | 4278 | 108296 | 42508657 |
| Plasma cell myeloma | 124.33 | 25.10 | 71 | 4311 | 47507 | 42569446 |
| Pneumonia | 108.77 | 25.10 | 171 | 4211 | 421978 | 42194975 |
| Neutropenia | 64.19 | 25.10 | 90 | 4292 | 199341 | 42417612 |
| Febrile infection | 40.83 | 25.10 | 14 | 4368 | 2757 | 42614196 |
| Platelet count decreased | 40.75 | 25.10 | 60 | 4322 | 138521 | 42478432 |
| Keratopathy | 39.45 | 25.10 | 10 | 4372 | 688 | 42616265 |
| Squamous cell carcinoma of skin | 38.64 | 25.10 | 21 | 4361 | 12705 | 42604248 |
| Neuropathy peripheral | 35.71 | 25.10 | 48 | 4334 | 101805 | 42515148 |
| Cytomegalovirus infection reactivation | 35.49 | 25.10 | 19 | 4363 | 11159 | 42605794 |
| Campylobacter gastroenteritis | 35.08 | 25.10 | 10 | 4372 | 1075 | 42615878 |
| Plasma cell myeloma refractory | 32.50 | 25.10 | 10 | 4372 | 1400 | 42615553 |
| Plasma cell myeloma recurrent | 30.90 | 25.10 | 14 | 4368 | 5743 | 42611210 |
| Sepsis | 30.75 | 25.10 | 65 | 4317 | 199269 | 42417684 |
| Factor VII deficiency | 30.52 | 25.10 | 5 | 4377 | 35 | 42616918 |
| Pyrexia | 30.37 | 25.10 | 99 | 4283 | 393943 | 42223010 |
| Anaemia | 29.78 | 25.10 | 79 | 4303 | 280199 | 42336754 |
| Pneumonia mycoplasmal | 28.91 | 25.10 | 8 | 4374 | 772 | 42616181 |
| White blood cell count decreased | 28.47 | 25.10 | 45 | 4337 | 110351 | 42506602 |
| Pneumonia respiratory syncytial viral | 28.16 | 25.10 | 9 | 4373 | 1425 | 42615528 |
| Respirovirus test positive | 27.25 | 25.10 | 5 | 4377 | 72 | 42616881 |
| Visceral leishmaniasis | 25.81 | 25.10 | 8 | 4374 | 1146 | 42615807 |
| 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 320.42 | 25.25 | 173 | 6635 | 174394 | 110408097 |
| Plasma cell myeloma | 262.78 | 25.25 | 110 | 6698 | 62826 | 110519665 |
| Pneumonia | 161.18 | 25.25 | 231 | 6577 | 876483 | 109706008 |
| Neutropenia | 140.22 | 25.25 | 142 | 6666 | 374478 | 110208013 |
| Platelet count decreased | 108.06 | 25.25 | 99 | 6709 | 230344 | 110352147 |
| Plasma cell myeloma recurrent | 89.19 | 25.25 | 28 | 6780 | 7014 | 110575477 |
| Anaemia | 88.28 | 25.25 | 136 | 6672 | 546950 | 110035541 |
| Pyrexia | 77.20 | 25.25 | 170 | 6638 | 898095 | 109684396 |
| Thrombocytopenia | 75.75 | 25.25 | 100 | 6708 | 348785 | 110233706 |
| Neutrophil count decreased | 70.77 | 25.25 | 59 | 6749 | 120882 | 110461609 |
| Cytomegalovirus infection reactivation | 69.60 | 25.25 | 30 | 6778 | 18303 | 110564188 |
| Sepsis | 62.21 | 25.25 | 88 | 6720 | 327258 | 110255233 |
| Plasma cell myeloma refractory | 57.17 | 25.25 | 15 | 6793 | 1986 | 110580505 |
| White blood cell count decreased | 54.81 | 25.25 | 69 | 6739 | 229321 | 110353170 |
| Lymphocyte count decreased | 53.61 | 25.25 | 37 | 6771 | 57206 | 110525285 |
| Febrile infection | 53.48 | 25.25 | 17 | 6791 | 4431 | 110578060 |
| Death | 50.77 | 25.25 | 124 | 6684 | 698745 | 109883746 |
| Cytomegalovirus infection | 50.53 | 25.25 | 35 | 6773 | 54409 | 110528082 |
| Paraproteinaemia | 47.09 | 25.25 | 10 | 6798 | 531 | 110581960 |
| Neuropathy peripheral | 46.14 | 25.25 | 56 | 6752 | 179221 | 110403270 |
| Septic shock | 43.48 | 25.25 | 51 | 6757 | 157477 | 110425014 |
| Febrile neutropenia | 43.07 | 25.25 | 73 | 6735 | 316694 | 110265797 |
| Keratopathy | 42.65 | 25.25 | 11 | 6797 | 1362 | 110581129 |
| Atrial fibrillation | 38.15 | 25.25 | 58 | 6750 | 229584 | 110352907 |
| Plasma cell leukaemia | 38.08 | 25.25 | 11 | 6797 | 2077 | 110580414 |
| Squamous cell carcinoma of skin | 36.94 | 25.25 | 19 | 6789 | 17184 | 110565307 |
| Campylobacter gastroenteritis | 34.46 | 25.25 | 10 | 6798 | 1919 | 110580572 |
| COVID-19 | 33.98 | 25.25 | 57 | 6751 | 245003 | 110337488 |
| Cytokine release syndrome | 32.46 | 25.25 | 30 | 6778 | 70276 | 110512215 |
| Pancytopenia | 32.10 | 25.25 | 51 | 6757 | 209562 | 110372929 |
| Pneumocystis jirovecii pneumonia | 31.72 | 25.25 | 24 | 6784 | 42711 | 110539780 |
| Deep vein thrombosis | 28.59 | 25.25 | 39 | 6769 | 139848 | 110442643 |
| Factor VII deficiency | 28.12 | 25.25 | 5 | 6803 | 103 | 110582388 |
| COVID-19 pneumonia | 27.88 | 25.25 | 21 | 6787 | 37122 | 110545369 |
| Bacteraemia | 27.54 | 25.25 | 22 | 6786 | 42368 | 110540123 |
| Acute myeloid leukaemia | 27.40 | 25.25 | 21 | 6787 | 38089 | 110544402 |
| Pulmonary embolism | 27.25 | 25.25 | 48 | 6760 | 214426 | 110368065 |
| Respirovirus test positive | 27.05 | 25.25 | 5 | 6803 | 129 | 110582362 |
| Listeriosis | 26.73 | 25.25 | 9 | 6799 | 2805 | 110579686 |
| Basal cell carcinoma | 26.27 | 25.25 | 22 | 6786 | 45248 | 110537243 |
| Human metapneumovirus test | 26.09 | 25.25 | 3 | 6805 | 0 | 110582491 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L01FX08 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates |
| FDA CS | M0001357 | Antibodies, Monoclonal |
| MeSH PA | D000970 | Antineoplastic Agents |
| FDA MoA | N0000192337 | SLAMF7-directed Antibody Interactions |
| FDA EPC | N0000192338 | SLAMF7-directed Immunostimulatory Antibody |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Multiple myeloma | indication | 109989006 | DOID:9538 |
| Relapse multiple myeloma | indication |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| SLAM family member 7 | Membrane receptor | ANTIBODY BINDING | Kd | 8.05 | IUPHAR | DRUG LABEL |
| ID | Source |
|---|---|
| 1351PE5UGS | UNII |
| 4035187 | VANDF |
| C1832049 | UMLSCUI |
| CHEBI:750089 | CHEBI |
| CHEMBL1743010 | ChEMBL_ID |
| DB06317 | DRUGBANK_ID |
| 9074 | INN_ID |
| C546027 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8361 | IUPHAR_LIGAND_ID |
| 1726104 | RXNORM |
| 237251 | MMSL |
| 31305 | MMSL |
| d08403 | MMSL |
| 016608 | NDDF |
| 715660001 | SNOMEDCT_US |
| 781350003 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| EMPLICITI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-2291 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 300 mg | INTRAVENOUS | BLA | 25 sections |
| EMPLICITI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-4522 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 400 mg | INTRAVENOUS | BLA | 25 sections |