Stem definition | Drug id | CAS RN |
---|---|---|
human origin | 5016 | 1245916-14-6 |
Molecule | Description |
---|---|
Synonyms:
|
antibody to PCSK9 to manage LDL cholesterol
|
Dose | Unit | Route |
---|---|---|
5.40 | mg | P |
None
Date | Agency | Company | Orphan |
---|---|---|---|
July 23, 2015 | EMA | ||
July 24, 2015 | FDA | SANOFI AVENTIS | |
July 4, 2016 | PMDA | Sanofi K.K. |
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 |
---|---|---|---|---|---|---|
Low density lipoprotein increased | 354.02 | 31.82 | 91 | 5919 | 6075 | 53336981 |
Myalgia | 345.98 | 31.82 | 204 | 5806 | 133287 | 53209769 |
Wrong technique in device usage process | 281.71 | 31.82 | 64 | 5946 | 2523 | 53340533 |
Device operational issue | 243.10 | 31.82 | 39 | 5971 | 212 | 53342844 |
Injury associated with device | 221.87 | 31.82 | 55 | 5955 | 3160 | 53339896 |
Drug dose omission by device | 214.06 | 31.82 | 51 | 5959 | 2478 | 53340578 |
Device issue | 198.65 | 31.82 | 79 | 5931 | 21579 | 53321477 |
Device use issue | 189.89 | 31.82 | 44 | 5966 | 1892 | 53341164 |
Injection site bruising | 171.60 | 31.82 | 84 | 5926 | 37562 | 53305494 |
Influenza like illness | 170.22 | 31.82 | 98 | 5912 | 60761 | 53282295 |
Product dose omission issue | 169.67 | 31.82 | 153 | 5857 | 191467 | 53151589 |
Product administered at inappropriate site | 156.76 | 31.82 | 40 | 5970 | 2582 | 53340474 |
Injection site pain | 140.40 | 31.82 | 110 | 5900 | 113281 | 53229775 |
Injection site erythema | 124.84 | 31.82 | 88 | 5922 | 77161 | 53265895 |
Injection site rash | 119.73 | 31.82 | 51 | 5959 | 16528 | 53326528 |
Muscle spasms | 115.85 | 31.82 | 106 | 5904 | 134689 | 53208367 |
Injection site pruritus | 92.85 | 31.82 | 58 | 5952 | 41531 | 53301525 |
Injection site swelling | 76.86 | 31.82 | 52 | 5958 | 42576 | 53300480 |
Injection site haemorrhage | 62.83 | 31.82 | 36 | 5974 | 22015 | 53321041 |
Rhinorrhoea | 61.91 | 31.82 | 50 | 5960 | 53528 | 53289528 |
Device defective | 58.89 | 31.82 | 16 | 5994 | 1315 | 53341741 |
Pruritus | 56.92 | 31.82 | 111 | 5899 | 293721 | 53049335 |
Injection site reaction | 51.32 | 31.82 | 44 | 5966 | 51122 | 53291934 |
Incorrect dose administered by device | 51.00 | 31.82 | 18 | 5992 | 3521 | 53339535 |
Low density lipoprotein decreased | 49.72 | 31.82 | 10 | 6000 | 217 | 53342839 |
Rash | 48.25 | 31.82 | 134 | 5876 | 446057 | 52896999 |
Therapeutic response decreased | 41.88 | 31.82 | 38 | 5972 | 47531 | 53295525 |
Blood triglycerides increased | 40.01 | 31.82 | 22 | 5988 | 12419 | 53330637 |
Underdose | 38.16 | 31.82 | 26 | 5984 | 21496 | 53321560 |
Pain in extremity | 36.19 | 31.82 | 91 | 5919 | 284959 | 53058097 |
Arthralgia | 36.12 | 31.82 | 120 | 5890 | 439663 | 52903393 |
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 |
---|---|---|---|---|---|---|
Myalgia | 372.35 | 29.02 | 186 | 3801 | 81044 | 32428495 |
Low density lipoprotein increased | 202.19 | 29.02 | 55 | 3932 | 4191 | 32505348 |
Influenza like illness | 162.61 | 29.02 | 75 | 3912 | 27065 | 32482474 |
Drug dose omission by device | 152.50 | 29.02 | 33 | 3954 | 949 | 32508590 |
Wrong technique in device usage process | 107.53 | 29.02 | 26 | 3961 | 1233 | 32508306 |
Device issue | 98.12 | 29.02 | 38 | 3949 | 8874 | 32500665 |
Low density lipoprotein decreased | 91.23 | 29.02 | 22 | 3965 | 1031 | 32508508 |
Injury associated with device | 90.00 | 29.02 | 21 | 3966 | 853 | 32508686 |
Product dose omission issue | 81.16 | 29.02 | 80 | 3907 | 102495 | 32407044 |
Device operational issue | 79.02 | 29.02 | 14 | 3973 | 135 | 32509404 |
Muscle spasms | 75.24 | 29.02 | 65 | 3922 | 70353 | 32439186 |
Injection site bruising | 74.36 | 29.02 | 30 | 3957 | 7790 | 32501749 |
Injection site erythema | 59.16 | 29.02 | 31 | 3956 | 14637 | 32494902 |
Rhinorrhoea | 56.12 | 29.02 | 35 | 3952 | 22951 | 32486588 |
Injection site pain | 55.79 | 29.02 | 40 | 3947 | 33018 | 32476521 |
Arthralgia | 49.80 | 29.02 | 75 | 3912 | 148373 | 32361166 |
Injection site swelling | 46.64 | 29.02 | 23 | 3964 | 9561 | 32499978 |
Injection site pruritus | 46.55 | 29.02 | 20 | 3967 | 6070 | 32503469 |
Pruritus | 45.98 | 29.02 | 67 | 3920 | 128635 | 32380904 |
Blood triglycerides increased | 42.74 | 29.02 | 25 | 3962 | 14594 | 32494945 |
Product administered at inappropriate site | 40.23 | 29.02 | 13 | 3974 | 1786 | 32507753 |
Injection site reaction | 39.78 | 29.02 | 22 | 3965 | 11547 | 32497992 |
Blood cholesterol increased | 38.26 | 29.02 | 25 | 3962 | 17732 | 32491807 |
Device defective | 36.56 | 29.02 | 9 | 3978 | 459 | 32509080 |
Pain in extremity | 35.52 | 29.02 | 57 | 3930 | 118844 | 32390695 |
Device use issue | 35.34 | 29.02 | 8 | 3979 | 283 | 32509256 |
Muscular weakness | 34.42 | 29.02 | 42 | 3945 | 67887 | 32441652 |
Product use issue | 34.10 | 29.02 | 37 | 3950 | 52740 | 32456799 |
Back pain | 32.84 | 29.02 | 53 | 3934 | 111000 | 32398539 |
Rash | 31.39 | 29.02 | 75 | 3912 | 209258 | 32300281 |
Injection site rash | 31.02 | 29.02 | 13 | 3974 | 3707 | 32505832 |
Source | Code | Description |
---|---|---|
ATC | C10AX14 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Other lipid modifying agents |
FDA CS | M0001357 | Antibodies, Monoclonal |
MeSH PA | D000924 | Anticholesteremic Agents |
MeSH PA | D000963 | Antimetabolites |
MeSH PA | D004791 | Enzyme Inhibitors |
MeSH PA | D000960 | Hypolipidemic Agents |
MeSH PA | D057847 | Lipid Regulating Agents |
MeSH PA | D000091362 | PCSK9 Inhibitors |
MeSH PA | D011480 | Protease Inhibitors |
MeSH PA | D015842 | Serine Proteinase Inhibitors |
FDA MoA | N0000191730 | PCSK9 Inhibitors |
FDA EPC | N0000191731 | PCSK9 Inhibitor |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Hypercholesterolemia | indication | 13644009 | |
Atherosclerosis | indication | 38716007 | DOID:1936 |
Familial hypercholesterolemia - heterozygous | indication | 238079002 | |
Complex dyslipidemia | indication | 109041000119107 |
None
None
None
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Proprotein convertase subtilisin/kexin type 9 | Enzyme | INHIBITOR | Kd | 9.42 | IUPHAR | DRUG LABEL |
ID | Source |
---|---|
D10335 | KEGG_DRUG |
4034685 | VUID |
N0000191810 | NUI |
4034685 | VANDF |
CHEMBL2109540 | ChEMBL_ID |
C571059 | MESH_SUPPLEMENTAL_RECORD_UI |
6744 | IUPHAR_LIGAND_ID |
9620 | INN_ID |
DB09302 | DRUGBANK_ID |
PP0SHH6V16 | UNII |
1659152 | RXNORM |
31129 | MMSL |
d08374 | MMSL |
016342 | NDDF |
715186005 | SNOMEDCT_US |
781355008 | SNOMEDCT_US |
C3491162 | UMLSCUI |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Praluent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0024-5901 | INJECTION, SOLUTION | 75 mg | SUBCUTANEOUS | BLA | 33 sections |
Praluent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0024-5902 | INJECTION, SOLUTION | 150 mg | SUBCUTANEOUS | BLA | 33 sections |
Praluent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0024-5903 | INJECTION, SOLUTION | 75 mg | SUBCUTANEOUS | BLA | 33 sections |
Praluent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0024-5904 | INJECTION, SOLUTION | 150 mg | SUBCUTANEOUS | BLA | 33 sections |
Praluent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61755-020 | INJECTION, SOLUTION | 75 mg | SUBCUTANEOUS | BLA | 33 sections |
Praluent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61755-021 | INJECTION, SOLUTION | 150 mg | SUBCUTANEOUS | BLA | 33 sections |
Praluent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72733-5901 | INJECTION, SOLUTION | 75 mg | SUBCUTANEOUS | BLA | 33 sections |
Praluent | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72733-5902 | INJECTION, SOLUTION | 150 mg | SUBCUTANEOUS | BLA | 33 sections |