gptkbp:instance_of
|
gptkb:pharmaceuticals
|
gptkbp:approves
|
gptkb:FDA
|
gptkbp:brand
|
gptkb:Tecfidera
|
gptkbp:clinical_trial
|
Phase III
DEFINE
CONFIRM
|
gptkbp:clinical_use
|
long-term treatment
disease-modifying therapy
|
gptkbp:condition
|
gptkb:relapsing_forms_of_multiple_sclerosis
|
gptkbp:contraindication
|
severe renal impairment
severe liver impairment
hypersensitivity to dimethyl fumarate
|
gptkbp:dosage_form
|
gptkb:capsule
240 mg daily
|
gptkbp:drug_interactions
|
live vaccines
other immunosuppressants
|
gptkbp:effective_date
|
March 2013
|
gptkbp:excretion
|
urine
feces
|
gptkbp:formulation
|
delayed-release capsule
|
https://www.w3.org/2000/01/rdf-schema#label
|
Tecfidera
|
gptkbp:ingredients
|
gptkb:dimethyl_fumarate
|
gptkbp:invention
|
2028
|
gptkbp:is_monitored_by
|
liver function tests
complete blood count
|
gptkbp:manufacturer
|
gptkb:Biogen
|
gptkbp:marketed_as
|
gptkb:European_Union
gptkb:United_States
|
gptkbp:mechanism_of_action
|
anti-inflammatory
immunomodulatory
|
gptkbp:patient_population
|
adults
pediatric patients
|
gptkbp:pharmacokinetics
|
absorbed in gastrointestinal tract
metabolized in liver
|
gptkbp:previous_name
|
gptkb:dimethyl_fumarate
|
gptkbp:route_of_administration
|
oral
|
gptkbp:safety
|
risk of progressive multifocal leukoencephalopathy (PML)
|
gptkbp:side_effect
|
headache
nausea
abdominal pain
diarrhea
liver enzyme elevation
skin rash
flushing
gastrointestinal events
|
gptkbp:storage
|
room temperature
protected from moisture
|
gptkbp:used_for
|
gptkb:multiple_sclerosis
|
gptkbp:bfsParent
|
gptkb:Biogen_MA_Inc.
gptkb:Biogen_Idec
gptkb:Biogen_Inc.
gptkb:BIIB
|
gptkbp:bfsLayer
|
5
|