Statements (69)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:Biology
|
| gptkbp:administered_by |
intravenous infusion
|
| gptkbp:advocacy |
supported by Fabry disease organizations
|
| gptkbp:affects |
may stabilize disease progression
|
| gptkbp:approves |
gptkb:2003
gptkb:European_Union gptkb:United_States |
| gptkbp:availability |
limited in some regions
|
| gptkbp:average_temperature |
2 to 8 degrees Celsius
|
| gptkbp:clinical_trial |
Phase III
Efficacy and Safety Study Long-term Safety Study ongoing for pediatric use |
| gptkbp:clinical_use |
long-term treatment
|
| gptkbp:contraindication |
hypersensitivity to agalsidase beta
|
| gptkbp:dosage_form |
solution for infusion
|
| gptkbp:dosing_adjustment |
based on clinical response
|
| gptkbp:drug_interactions |
may interact with other medications
|
| gptkbp:duration |
every 2 weeks
lifelong therapy |
| gptkbp:eligibility |
based on enzyme levels
|
| gptkbp:feedback |
generally positive
|
| gptkbp:financial_support |
gptkb:Genzyme_Patient_Services
|
| gptkbp:formulation |
lyophilized powder for reconstitution
|
| gptkbp:funding |
supported by grants and institutions
|
| gptkbp:healthcare |
may require prior authorization
requires specialist oversight |
| https://www.w3.org/2000/01/rdf-schema#label |
Fabrazyme
|
| gptkbp:indication |
enzyme deficiency
|
| gptkbp:ingredients |
gptkb:agalsidase_beta
|
| gptkbp:is_monitored_by |
regular monitoring required
|
| gptkbp:manufacturer |
gptkb:Genzyme_Corporation
|
| gptkbp:marketed_as |
gptkb:Fabrazyme
|
| gptkbp:mechanism_of_action |
replaces deficient enzyme
|
| gptkbp:packaging |
single-use vials
|
| gptkbp:patient_education |
important for adherence
|
| gptkbp:patient_population |
adults and children
|
| gptkbp:pharmaceutical_class |
gptkb:pharmaceuticals
|
| gptkbp:pharmacokinetics |
half-life of approximately 2 hours
|
| gptkbp:pharmacovigilance |
important for safety monitoring
|
| gptkbp:price |
high
|
| gptkbp:provides_guidance_on |
recommended in treatment guidelines
|
| gptkbp:recommissioned |
requires sterile water for injection
|
| gptkbp:regulatory_compliance |
prescription only
|
| gptkbp:research |
ongoing studies for new indications
|
| gptkbp:route_of_administration |
intravenous
|
| gptkbp:safety_features |
generally well tolerated
|
| gptkbp:safety_measures |
adverse event reporting required
|
| gptkbp:sales |
available in multiple countries
|
| gptkbp:shelf_life |
24 months
|
| gptkbp:side_effect |
fatigue
headache nausea abdominal pain improves quality of life gastrointestinal complications infusion reactions neurological complications cardiovascular complications renal complications |
| gptkbp:treatment |
monitored regularly
improved enzyme levels reduce symptoms and complications |
| gptkbp:type_of_insurance |
coverage varies by plan
|
| gptkbp:used_for |
treatment of Fabry disease
|
| gptkbp:bfsParent |
gptkb:Genzyme
gptkb:Sanofi_Genzyme gptkb:Shire_plc |
| gptkbp:bfsLayer |
5
|