Tegsedi

E133690

Tegsedi is an antisense oligonucleotide drug used to treat hereditary transthyretin-mediated amyloidosis by reducing the production of the transthyretin protein.

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Label Occurrences
Tegsedi canonical 1

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Statements (45)

Predicate Object
instanceOf antisense oligonucleotide
pharmaceutical drug
transthyretin-directed therapy
administeredTo human patients
approvalYear 2018
approvedBy European Medicines Agency
Food and Drug Administration
surface form: U.S. Food and Drug Administration
belongsTo Ionis Pharmaceuticals
surface form: Ionis antisense pipeline
blackBoxWarningFor glomerulonephritis
thrombocytopenia
coDevelopedBy Akcea Therapeutics
commonAdverseEvent fatigue
headache
injection site reactions
nausea
developedBy Ionis Pharmaceuticals
dosingFrequency once weekly
hasActiveIngredient inotersen
hasATCCode N07XX11
hasDosageForm solution for injection
hasInternationalNonproprietaryName inotersen
indicatedFor adults with hereditary transthyretin-mediated amyloidosis
is first-in-class antisense drug for hereditary transthyretin-mediated amyloidosis
isAdministeredBy healthcare professional or trained patient
legalStatusInEuropeanUnion prescription-only medicine
legalStatusInUnitedStates prescription-only medicine
mechanismOfAction antisense-mediated degradation of TTR mRNA
transthyretin synthesis inhibition
molecularTarget TTR gene transcript
pharmacologicalClass antisense therapeutic
reduces amyloid deposition progression
serum transthyretin levels
reducesLevelOf transthyretin protein
reducesRiskOf progression of polyneuropathy in hATTR patients
regulatoryDesignation orphan drug in the United States
orphan medicinal product in the European Union
requires regular platelet monitoring
renal function monitoring
routeOfAdministration subcutaneous injection
targets transthyretin mRNA
therapyArea amyloidosis
neurology
rare diseases
treats hereditary transthyretin-mediated amyloidosis
polyneuropathy of hereditary transthyretin-mediated amyloidosis

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Full triples — surface form annotated when it differs from this entity's canonical label.