|
gptkbp:instance_of
|
gptkb:Biology
|
|
gptkbp:administered_by
|
intravenous infusion
|
|
gptkbp:approves
|
gptkb:2003
|
|
gptkbp:clinical_trial
|
gptkb:Shire_Pharmaceuticals
multiple countries
Phase III
|
|
gptkbp:clinical_use
|
long-term treatment
|
|
gptkbp:condition
|
gptkb:Fabry_disease
lysosomal storage disorders
|
|
gptkbp:contraindication
|
hypersensitivity to agalsidase alfa
|
|
gptkbp:dosage_form
|
solution for infusion
|
|
gptkbp:duration
|
every 2 weeks
|
|
gptkbp:effective_date
|
FDA approved
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Replagal
|
|
gptkbp:indication
|
chronic kidney disease
neuropathic pain
cardiac involvement
|
|
gptkbp:ingredients
|
gptkb:agalsidase_alfa
|
|
gptkbp:invention
|
patented
|
|
gptkbp:manufacturer
|
gptkb:Shire_Pharmaceuticals
|
|
gptkbp:marketed_as
|
gptkb:Australia
gptkb:Canada
gptkb:European_Union
gptkb:United_States
|
|
gptkbp:mechanism_of_action
|
replaces deficient enzyme
|
|
gptkbp:packaging
|
vial
|
|
gptkbp:patient_population
|
patients with confirmed diagnosis
|
|
gptkbp:pharmacokinetics
|
increases enzyme activity
half-life of 65 hours
|
|
gptkbp:provides_guidance_on
|
recommended for Fabry disease
|
|
gptkbp:research_focus
|
gptkb:gene_therapy
new formulations
|
|
gptkbp:route_of_administration
|
intravenous
|
|
gptkbp:side_effect
|
fatigue
headache
nausea
abdominal pain
fever
urticaria
rash
anaphylaxis
angioedema
infusion reactions
|
|
gptkbp:storage
|
2 to 8 degrees Celsius
|
|
gptkbp:target_audience
|
adults and children
|
|
gptkbp:treatment
|
improve quality of life
prevent complications
reduce symptoms
reduce pain
stabilize kidney function
|
|
gptkbp:used_for
|
gptkb:Fabry_disease
|
|
gptkbp:bfsParent
|
gptkb:Shire_plc
|
|
gptkbp:bfsLayer
|
5
|