Stem definition | Drug id | CAS RN |
---|---|---|
humanized origin | 5083 | 1143503-69-8 |
Molecule | Description |
---|---|
Synonyms:
|
A humanized anti-interleukin 17 monoclonal antibody used for the treatment of PSORIASIS.
|
Dose | Unit | Route |
---|---|---|
2.90 | mg | P |
None
Date | Agency | Company | Orphan |
---|---|---|---|
July 4, 2016 | PMDA | Eli Lilly Japan | |
Feb. 25, 2016 | EMA | ||
March 22, 2016 | FDA | ELI LILLY AND CO |
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 |
---|---|---|---|---|---|---|
Injection site erythema | 582.34 | 25.28 | 286 | 9605 | 74650 | 50520583 |
Injection site pain | 521.58 | 25.28 | 303 | 9588 | 110721 | 50484512 |
Therapy interrupted | 490.55 | 25.28 | 174 | 9717 | 19978 | 50575255 |
Injection site reaction | 486.40 | 25.28 | 223 | 9668 | 49809 | 50545424 |
Injection site swelling | 485.44 | 25.28 | 211 | 9680 | 41562 | 50553671 |
Therapy cessation | 294.01 | 25.28 | 129 | 9762 | 25882 | 50569351 |
COVID-19 | 236.02 | 25.28 | 134 | 9757 | 46528 | 50548705 |
Injection site urticaria | 172.48 | 25.28 | 71 | 9820 | 12146 | 50583087 |
Injection site pruritus | 172.45 | 25.28 | 104 | 9787 | 40307 | 50554926 |
Injection site warmth | 154.06 | 25.28 | 68 | 9823 | 13798 | 50581435 |
Psoriasis | 141.19 | 25.28 | 113 | 9778 | 68887 | 50526346 |
Injection site rash | 140.96 | 25.28 | 67 | 9824 | 16110 | 50579123 |
Drug ineffective | 120.93 | 25.28 | 391 | 9500 | 818942 | 49776291 |
Ear infection | 108.56 | 25.28 | 66 | 9825 | 25904 | 50569329 |
Sinusitis | 86.27 | 25.28 | 134 | 9757 | 170424 | 50424809 |
Tooth infection | 64.50 | 25.28 | 38 | 9853 | 14074 | 50581159 |
Nasopharyngitis | 64.11 | 25.28 | 126 | 9765 | 192801 | 50402432 |
Pharyngitis streptococcal | 63.29 | 25.28 | 32 | 9859 | 8776 | 50586457 |
Fungal infection | 63.18 | 25.28 | 50 | 9841 | 29915 | 50565318 |
Psoriatic arthropathy | 61.88 | 25.28 | 60 | 9831 | 46972 | 50548261 |
Injection site mass | 60.80 | 25.28 | 38 | 9853 | 15642 | 50579591 |
Urticaria | 57.51 | 25.28 | 96 | 9795 | 129465 | 50465768 |
Product dose omission issue | 57.39 | 25.28 | 117 | 9774 | 183721 | 50411512 |
Injection site bruising | 54.27 | 25.28 | 50 | 9841 | 36718 | 50558515 |
Infection | 50.37 | 25.28 | 107 | 9784 | 172847 | 50422386 |
Inappropriate schedule of product administration | 50.33 | 25.28 | 66 | 9825 | 71765 | 50523468 |
Illness | 47.59 | 25.28 | 39 | 9852 | 24501 | 50570732 |
SARS-CoV-2 test positive | 45.83 | 25.28 | 21 | 9870 | 4638 | 50590595 |
Surgery | 40.59 | 25.28 | 39 | 9852 | 30166 | 50565067 |
Urinary tract infection | 40.09 | 25.28 | 115 | 9776 | 223905 | 50371328 |
Therapy non-responder | 39.06 | 25.28 | 49 | 9842 | 50973 | 50544260 |
Accidental underdose | 38.07 | 25.28 | 11 | 9880 | 647 | 50594586 |
Chronic disease | 35.16 | 25.28 | 7 | 9884 | 80 | 50595153 |
Pruritus | 34.83 | 25.28 | 128 | 9763 | 283440 | 50311793 |
Injection related reaction | 34.53 | 25.28 | 10 | 9881 | 593 | 50594640 |
Influenza | 34.03 | 25.28 | 62 | 9829 | 89476 | 50505757 |
Acute kidney injury | 33.57 | 25.28 | 3 | 9888 | 228055 | 50367178 |
Upper respiratory tract infection | 33.53 | 25.28 | 52 | 9839 | 65846 | 50529387 |
Inflammatory bowel disease | 32.22 | 25.28 | 15 | 9876 | 3435 | 50591798 |
Wrong technique in device usage process | 30.22 | 25.28 | 13 | 9878 | 2473 | 50592760 |
Demyelinating polyneuropathy | 30.10 | 25.28 | 9 | 9882 | 597 | 50594636 |
Injection site cellulitis | 27.97 | 25.28 | 10 | 9881 | 1165 | 50594068 |
Hypotension | 27.88 | 25.28 | 6 | 9885 | 235463 | 50359770 |
Candida infection | 27.21 | 25.28 | 28 | 9863 | 23495 | 50571738 |
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 |
---|---|---|---|---|---|---|
Injection site pain | 397.00 | 31.33 | 171 | 5752 | 32275 | 29536329 |
Injection site reaction | 381.22 | 31.33 | 125 | 5798 | 11063 | 29557541 |
Injection site erythema | 323.82 | 31.33 | 117 | 5806 | 13839 | 29554765 |
Injection site swelling | 256.55 | 31.33 | 89 | 5834 | 9328 | 29559276 |
Therapy interrupted | 223.55 | 31.33 | 78 | 5845 | 8308 | 29560296 |
Therapy cessation | 205.70 | 31.33 | 85 | 5838 | 14377 | 29554227 |
Psoriasis | 203.61 | 31.33 | 108 | 5815 | 32119 | 29536485 |
Drug ineffective | 143.07 | 31.33 | 257 | 5666 | 362913 | 29205691 |
COVID-19 | 127.47 | 31.33 | 83 | 5840 | 35931 | 29532673 |
Injection site pruritus | 106.08 | 31.33 | 41 | 5882 | 5808 | 29562796 |
Injection site rash | 94.31 | 31.33 | 33 | 5890 | 3531 | 29565073 |
Nasopharyngitis | 90.25 | 31.33 | 83 | 5840 | 59582 | 29509022 |
Ear infection | 83.58 | 31.33 | 38 | 5885 | 8062 | 29560542 |
Sinusitis | 68.51 | 31.33 | 56 | 5867 | 34294 | 29534310 |
Infection | 66.03 | 31.33 | 79 | 5844 | 76672 | 29491932 |
Pruritus | 57.75 | 31.33 | 92 | 5831 | 116757 | 29451847 |
Influenza | 57.00 | 31.33 | 55 | 5868 | 41826 | 29526778 |
Injection site warmth | 56.25 | 31.33 | 19 | 5904 | 1827 | 29566777 |
Injection site urticaria | 50.90 | 31.33 | 17 | 5906 | 1579 | 29567025 |
Inappropriate schedule of product administration | 47.05 | 31.33 | 51 | 5872 | 44421 | 29524183 |
Psoriatic arthropathy | 45.01 | 31.33 | 31 | 5892 | 14660 | 29553944 |
Wrong technique in device usage process | 44.55 | 31.33 | 14 | 5909 | 1071 | 29567533 |
Injection site bruising | 43.82 | 31.33 | 24 | 5899 | 7556 | 29561048 |
Product dose omission issue | 43.65 | 31.33 | 73 | 5850 | 96310 | 29472294 |
Insurance issue | 42.19 | 31.33 | 13 | 5910 | 932 | 29567672 |
SARS-CoV-2 test positive | 42.17 | 31.33 | 18 | 5905 | 3281 | 29565323 |
Ejection fraction decreased | 40.40 | 31.33 | 30 | 5893 | 15948 | 29552656 |
Fungal infection | 39.87 | 31.33 | 28 | 5895 | 13657 | 29554947 |
Injection site mass | 39.27 | 31.33 | 20 | 5903 | 5435 | 29563169 |
Rash | 39.05 | 31.33 | 104 | 5819 | 189715 | 29378889 |
Acute kidney injury | 38.99 | 31.33 | 4 | 5919 | 265263 | 29303341 |
Therapy non-responder | 37.23 | 31.33 | 38 | 5885 | 30873 | 29537731 |
Intestinal haemorrhage | 36.73 | 31.33 | 16 | 5907 | 3063 | 29565541 |
Cellulitis | 35.82 | 31.33 | 45 | 5878 | 45795 | 29522809 |
Illness | 35.48 | 31.33 | 20 | 5903 | 6654 | 29561950 |
Arthralgia | 33.35 | 31.33 | 81 | 5842 | 139536 | 29429068 |
Knee operation | 32.78 | 31.33 | 12 | 5911 | 1460 | 29567144 |
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 |
---|---|---|---|---|---|---|
Therapy interrupted | 763.06 | 23.92 | 235 | 10862 | 19801 | 64467834 |
Injection site erythema | 439.52 | 23.92 | 223 | 10874 | 70577 | 64417058 |
Injection site pain | 429.26 | 23.92 | 256 | 10841 | 111152 | 64376483 |
Injection site swelling | 419.78 | 23.92 | 183 | 10914 | 41170 | 64446465 |
Therapy cessation | 400.27 | 23.92 | 165 | 10932 | 32324 | 64455311 |
Injection site reaction | 395.42 | 23.92 | 182 | 10915 | 46482 | 64441153 |
COVID-19 | 360.44 | 23.92 | 190 | 10907 | 64950 | 64422685 |
Ear infection | 187.77 | 23.92 | 88 | 11009 | 23316 | 64464319 |
Sinusitis | 173.56 | 23.92 | 166 | 10931 | 145762 | 64341873 |
Psoriasis | 159.04 | 23.92 | 117 | 10980 | 71586 | 64416049 |
Injection site pruritus | 145.38 | 23.92 | 87 | 11010 | 37739 | 64449896 |
Nasopharyngitis | 134.65 | 23.92 | 167 | 10930 | 195906 | 64291729 |
Injection site warmth | 134.48 | 23.92 | 59 | 11038 | 13403 | 64474232 |
Psoriatic arthropathy | 110.54 | 23.92 | 77 | 11020 | 43204 | 64444431 |
Drug ineffective | 109.61 | 23.92 | 354 | 10743 | 839893 | 63647742 |
Injection site urticaria | 108.43 | 23.92 | 48 | 11049 | 11133 | 64476502 |
Injection site rash | 107.44 | 23.92 | 53 | 11044 | 15689 | 64471946 |
Illness | 101.65 | 23.92 | 57 | 11040 | 21881 | 64465754 |
Infection | 96.84 | 23.92 | 138 | 10959 | 184742 | 64302893 |
Product dose omission issue | 89.92 | 23.92 | 137 | 10960 | 194610 | 64293025 |
Fungal infection | 80.64 | 23.92 | 58 | 11039 | 34193 | 64453442 |
SARS-CoV-2 test positive | 74.15 | 23.92 | 31 | 11066 | 6255 | 64481380 |
Pharyngitis streptococcal | 73.85 | 23.92 | 34 | 11063 | 8634 | 64479001 |
Tooth infection | 70.53 | 23.92 | 39 | 11058 | 14562 | 64473073 |
Surgery | 69.23 | 23.92 | 49 | 11048 | 28164 | 64459471 |
Inappropriate schedule of product administration | 65.43 | 23.92 | 80 | 11017 | 92206 | 64395429 |
Acute kidney injury | 53.70 | 23.92 | 7 | 11090 | 449233 | 64038402 |
Drug interaction | 50.36 | 23.92 | 3 | 11094 | 362080 | 64125555 |
Wrong technique in device usage process | 47.16 | 23.92 | 18 | 11079 | 2864 | 64484771 |
Injection site bruising | 46.20 | 23.92 | 43 | 11054 | 36330 | 64451305 |
Pruritus | 43.38 | 23.92 | 135 | 10962 | 312265 | 64175370 |
Cellulitis | 43.29 | 23.92 | 66 | 11031 | 93591 | 64394044 |
Inflammatory bowel disease | 42.44 | 23.92 | 19 | 11078 | 4519 | 64483116 |
Injection site mass | 42.37 | 23.92 | 30 | 11067 | 17240 | 64470395 |
Intentional dose omission | 41.46 | 23.92 | 20 | 11077 | 5632 | 64482003 |
Product dispensing error | 40.52 | 23.92 | 25 | 11072 | 11425 | 64476210 |
Upper respiratory tract infection | 40.49 | 23.92 | 56 | 11041 | 72729 | 64414906 |
Hypotension | 38.82 | 23.92 | 9 | 11088 | 380965 | 64106670 |
Wrong schedule | 36.87 | 23.92 | 9 | 11088 | 313 | 64487322 |
Localised infection | 35.14 | 23.92 | 34 | 11063 | 30127 | 64457508 |
Manufacturing product shipping issue | 35.08 | 23.92 | 7 | 11090 | 93 | 64487542 |
Chronic disease | 34.81 | 23.92 | 7 | 11090 | 97 | 64487538 |
Influenza | 34.45 | 23.92 | 64 | 11033 | 106467 | 64381168 |
Insurance issue | 33.54 | 23.92 | 14 | 11083 | 2812 | 64484823 |
Bronchitis | 31.08 | 23.92 | 62 | 11035 | 108681 | 64378954 |
Injection related reaction | 30.38 | 23.92 | 9 | 11088 | 658 | 64486977 |
Rash | 30.21 | 23.92 | 157 | 10940 | 458392 | 64029243 |
Urinary tract infection | 30.19 | 23.92 | 98 | 10999 | 231498 | 64256137 |
Intestinal haemorrhage | 30.16 | 23.92 | 16 | 11081 | 5498 | 64482137 |
Urticaria | 29.67 | 23.92 | 73 | 11024 | 147244 | 64340391 |
Spinal operation | 28.57 | 23.92 | 16 | 11081 | 6117 | 64481518 |
Product distribution issue | 28.35 | 23.92 | 9 | 11088 | 829 | 64486806 |
Skin disorder | 26.39 | 23.92 | 28 | 11069 | 27652 | 64459983 |
Antibiotic therapy | 25.06 | 23.92 | 8 | 11089 | 751 | 64486884 |
Confusional state | 24.98 | 23.92 | 7 | 11090 | 261137 | 64226498 |
Oral candidiasis | 24.87 | 23.92 | 25 | 11072 | 23187 | 64464448 |
Device malfunction | 24.64 | 23.92 | 22 | 11075 | 17611 | 64470024 |
Oropharyngeal pain | 24.59 | 23.92 | 50 | 11047 | 88817 | 64398818 |
None
Source | Code | Description |
---|---|---|
ATC | L04AC13 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors |
MeSH PA | D003879 | Dermatologic Agents |
FDA MoA | N0000191494 | Interleukin-17A Antagonists |
FDA EPC | N0000191495 | Interleukin-17A Antagonist |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Ankylosing spondylitis | indication | 9631008 | DOID:7147 |
Psoriatic arthritis | indication | 156370009 | DOID:9008 |
Plaque psoriasis | indication | 200965009 | |
Pustular psoriasis | indication | 200973000 | |
Erythrodermic psoriasis | indication | 200977004 | |
Non-radiographic axial spondyloarthritis | indication | 713777005 |
None
None
None
None
None
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Interleukin-17A | Cytokine | ANTIBODY BINDING | DRUG LABEL | DRUG LABEL |
ID | Source |
---|---|
BTY153760O | UNII |
D10071 | KEGG_DRUG |
4035606 | VANDF |
C3489764 | UMLSCUI |
CHEMBL1743034 | ChEMBL_ID |
DB11569 | DRUGBANK_ID |
9467 | INN_ID |
C549079 | MESH_SUPPLEMENTAL_RECORD_UI |
7541 | IUPHAR_LIGAND_ID |
1745099 | RXNORM |
31578 | MMSL |
d08425 | MMSL |
724037000 | SNOMEDCT_US |
763603002 | SNOMEDCT_US |
016752 | NDDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
TALTZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-1445 | INJECTION, SOLUTION | 80 mg | SUBCUTANEOUS | BLA | 30 sections |
TALTZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-1445 | INJECTION, SOLUTION | 80 mg | SUBCUTANEOUS | BLA | 30 sections |
TALTZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-7724 | INJECTION, SOLUTION | 80 mg | SUBCUTANEOUS | BLA | 30 sections |
TALTZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-7724 | INJECTION, SOLUTION | 80 mg | SUBCUTANEOUS | BLA | 30 sections |