|
gptkbp:instanceOf
|
drug
|
|
gptkbp:administrativeDivision
|
lumbar puncture
every 4 months after loading doses
|
|
gptkbp:bombLoad
|
12 mg
|
|
gptkbp:clinicalTrials
|
Phase 3
neuromuscular disease
included in treatment protocols
CHERISH
ENDEAR
NURTURE
SHINE
|
|
gptkbp:community_service
|
available
|
|
gptkbp:compatibleWith
|
not applicable
|
|
gptkbp:contraindication
|
none known
serious adverse events
|
|
gptkbp:date
|
FDA_approved
|
|
gptkbp:developedBy
|
gptkb:Ionis_Pharmaceuticals
|
|
gptkbp:dosageForm
|
solution
|
|
gptkbp:drugInterdiction
|
none known
antisense therapy
dose-dependent exposure
increases SMN protein levels
|
|
gptkbp:firstAwarded
|
2017
|
|
gptkbp:formulation
|
sterile solution for injection
|
|
gptkbp:hasPopulation
|
adults
infants and children
|
|
gptkbp:healthcare
|
strong community support
varies by trial
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Nusinersen
|
|
gptkbp:impact
|
ongoing therapy
|
|
gptkbp:is_monitored_by
|
adverse effects
clinical response
|
|
gptkbp:is_used_in
|
unknown
|
|
gptkbp:lastProduced
|
December 2016
|
|
gptkbp:launchSite
|
lumbar region
|
|
gptkbp:maintenanceFee
|
12 mg
|
|
gptkbp:market
|
2017
|
|
gptkbp:marketedAs
|
gptkb:Biogen
|
|
gptkbp:numberOfStudents
|
approximately 4 hours
|
|
gptkbp:offers
|
high
|
|
gptkbp:patentStatus
|
patented
|
|
gptkbp:regulatoryCompliance
|
gptkb:Health_Canada
gptkb:TGA_Australia
gptkb:European_Medicines_Agency
|
|
gptkbp:research
|
public and private sources
|
|
gptkbp:researchFocus
|
spinal muscular atrophy
|
|
gptkbp:researchInterest
|
ongoing
|
|
gptkbp:route
|
intrathecal injection
|
|
gptkbp:safetyFeatures
|
generally well tolerated
|
|
gptkbp:sells
|
gptkb:Spinraza
|
|
gptkbp:sideEffect
|
headache
nausea
constipation
back pain
injection site reactions
|
|
gptkbp:storage
|
refrigerated
|
|
gptkbp:targets
|
SMN2 gene
|
|
gptkbp:triggerType
|
gptkb:antisense_oligonucleotide
|
|
gptkbp:usedFor
|
treatment of spinal muscular atrophy
|