inotersen
E561115
Inotersen is an antisense oligonucleotide drug used to treat hereditary transthyretin-mediated amyloidosis by reducing the production of transthyretin protein.
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
antisense oligonucleotide drug
ⓘ
pharmacologic substance ⓘ transthyretin synthesis inhibitor ⓘ |
| approvedBy |
European Medicines Agency
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| belongsToTherapeuticArea |
neurology
ⓘ
rare diseases ⓘ |
| bindsTo | TTR mRNA in the liver ⓘ |
| contraindication |
history of serious hypersensitivity to inotersen
ⓘ
severe thrombocytopenia ⓘ |
| developedBy | Ionis Pharmaceuticals NERFINISHED ⓘ |
| EMAApprovalYear | 2018 ⓘ |
| FDAApprovalYear | 2018 ⓘ |
| hasAdministrationFrequency | once weekly ⓘ |
| hasATCCode | N07XX14 ⓘ |
| hasBackboneModification | phosphorothioate ⓘ |
| hasBlackBoxWarningFor |
glomerulonephritis
ⓘ
thrombocytopenia ⓘ |
| hasChemicalNature | single-stranded antisense oligonucleotide ⓘ |
| hasCommonAdverseEffect |
fatigue
ⓘ
headache ⓘ injection site reactions ⓘ nausea ⓘ |
| hasDosingForm | pre-filled syringe ⓘ |
| hasINN | inotersen ⓘ |
| hasMolecularType | 2′-O-methoxyethyl–modified antisense oligonucleotide ⓘ |
| hasPregnancyCategory | not recommended in pregnancy unless clearly needed ⓘ |
| hasRouteOfAdministration | subcutaneous injection ⓘ |
| hasSeriousAdverseEffect |
glomerulonephritis
ⓘ
immune-mediated reactions ⓘ severe thrombocytopenia ⓘ |
| hasTradeName | Tegsedi NERFINISHED ⓘ |
| indication |
hereditary transthyretin-mediated amyloidosis
ⓘ
polyneuropathy of hereditary transthyretin-mediated amyloidosis ⓘ |
| legalStatusInEuropeanUnion | prescription only ⓘ |
| legalStatusInUnitedStates | prescription only ⓘ |
| marketedBy | Akcea Therapeutics NERFINISHED ⓘ |
| mechanismOfAction |
RNase H–mediated degradation of TTR mRNA
ⓘ
inhibition of transthyretin protein synthesis ⓘ |
| primarySiteOfAction | liver ⓘ |
| reduces | serum transthyretin concentration ⓘ |
| reducesLevelOf | transthyretin protein ⓘ |
| requiresMonitoringOf |
platelet count
ⓘ
renal function ⓘ |
| requiresRiskManagementProgram | yes ⓘ |
| targets | transthyretin mRNA ⓘ |
| treatsSymptom |
autonomic neuropathy in hATTR
ⓘ
sensorimotor polyneuropathy in hATTR ⓘ |
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.