gptkbp:instance_of
|
gptkb:pharmaceuticals
|
gptkbp:administered_by
|
oral tablet
|
gptkbp:approves
|
gptkb:FDA
January 31, 2012
|
gptkbp:availability
|
prescription only
|
gptkbp:bioavailability
|
approximately 50%
|
gptkbp:brand
|
gptkb:Kalydeco
|
gptkbp:chemical_formula
|
C24 H28 Cl N3 O3 S
|
gptkbp:class
|
gptkb:Cystic_fibrosis_transmembrane_conductance_regulator_(CFTR)_modulators
|
gptkbp:clinical_trial
|
Phase 3
VX-770-101
VX-770-102
VX-770-103
VX-770-104
|
gptkbp:clinical_use
|
long-term treatment
|
gptkbp:composed_by
|
gptkb:chemical_compound
|
gptkbp:contraindication
|
severe liver impairment
|
gptkbp:discovered_by
|
gptkb:Vertex_Pharmaceuticals
|
gptkbp:dosage_form
|
tablets
|
gptkbp:excretion
|
bile
|
gptkbp:formulation
|
film-coated tablets
|
https://www.w3.org/2000/01/rdf-schema#label
|
Ivacaftor
|
gptkbp:indication
|
G551 D mutation in CFTR gene
|
gptkbp:ingredients
|
gptkb:Ivacaftor
|
gptkbp:interacts_with
|
strong CYP3 A inducers
strong CYP3 A inhibitors
|
gptkbp:invention
|
patented
|
gptkbp:lifespan
|
approximately 12 hours
|
gptkbp:marketed_as
|
gptkb:Canada
gptkb:European_Union
gptkb:United_States
|
gptkbp:mechanism_of_action
|
potentiator of CFTR
|
gptkbp:metabolism
|
liver
|
gptkbp:patient_population
|
children and adults
|
gptkbp:pharmacokinetics
|
variable absorption
increases chloride transport
|
gptkbp:price
|
high
|
gptkbp:provides_guidance_on
|
Cystic Fibrosis Foundation guidelines
|
gptkbp:regulatory_compliance
|
gptkb:Health_Canada
gptkb:EMA
TGA
|
gptkbp:research_focus
|
gptkb:CFTR_modulators
|
gptkbp:rounds
|
urine
|
gptkbp:route_of_administration
|
oral
|
gptkbp:safety_features
|
generally well tolerated
|
gptkbp:side_effect
|
dizziness
fatigue
headache
nausea
abdominal pain
diarrhea
rash
upper respiratory tract infection
liver function abnormalities
|
gptkbp:storage
|
room temperature
|
gptkbp:targets
|
CFTR protein
|
gptkbp:type_of_care
|
important for efficacy
|
gptkbp:used_for
|
gptkb:cystic_fibrosis
|
gptkbp:bfsParent
|
gptkb:Symdeko
gptkb:CFTR_modulators
|
gptkbp:bfsLayer
|
5
|