Statements (57)
Predicate | Object |
---|---|
gptkbp:instance_of |
gptkb:Biology
|
gptkbp:administered_by |
intravenous infusion
|
gptkbp:approves |
gptkb:2003
gptkb:FDA |
gptkbp:availability |
prescription only
|
gptkbp:available_on |
lyophilized powder
|
gptkbp:chemical_formula |
C_2_0 H_3_0 N_6 O_1_3 S_1_0
|
gptkbp:clinical_trial |
Phase III
|
gptkbp:clinical_use |
long-term management
|
gptkbp:contraindication |
hypersensitivity to agalsidase alfa
|
gptkbp:developed_by |
gptkb:Genzyme
|
gptkbp:drug_interactions |
none known
|
gptkbp:duration |
long-term
|
gptkbp:financial_stability |
24 months
|
gptkbp:financial_support |
available through manufacturer
|
gptkbp:historical_significance |
first approved treatment for Fabry disease
|
https://www.w3.org/2000/01/rdf-schema#label |
agalsidase alfa
|
gptkbp:indication |
chronic kidney disease
|
gptkbp:ingredients |
gptkb:agalsidase_alfa
|
gptkbp:is_monitored_by |
cardiac function
renal function neurological function |
gptkbp:marketed_as |
the brand name Fabrazyme
|
gptkbp:mechanism_of_action |
replaces deficient enzyme
|
gptkbp:patient_education |
important for understanding treatment
|
gptkbp:patient_population |
adults and children
|
gptkbp:pharmacokinetics |
dose-dependent clearance
increases enzyme activity |
gptkbp:price |
high
|
gptkbp:provides_guidance_on |
recommended for Fabry disease
|
gptkbp:recommissioned |
with sterile water
|
gptkbp:regulatory_compliance |
orphan drug designation
marketed in multiple countries |
gptkbp:research_focus |
combination therapies
new formulations gene therapy alternatives |
gptkbp:route_of_administration |
IV
|
gptkbp:service_frequency |
every 2 weeks
|
gptkbp:side_effect |
fatigue
headache nausea abdominal pain urticaria rash anaphylaxis infusion reactions arthralgia myalgia |
gptkbp:storage |
refrigerated
|
gptkbp:treatment |
improved quality of life
reduced symptoms slowed disease progression |
gptkbp:type_of_care |
important for efficacy
|
gptkbp:used_for |
gptkb:Fabry_disease
|
gptkbp:weight |
45 k Da
|
gptkbp:bfsParent |
gptkb:Replagal
|
gptkbp:bfsLayer |
6
|