How much does REPLAGAL (Agalsidase Alfa Concentrated Solution for Infusion) Cost& price without insurance in China?
REPLAGAL® is the commercial brand name of Agalsidase Alfa Concentrated Solution for Infusion, developed by Shire Human Genetic Therapies AB and manufactured by Vetter Pharma-Fertigung GmbH & Co.KG, distributed by Takeda. It is a recombinant human alpha-galactosidase enzyme replacement therapy. The exogenous enzyme supplements deficient endogenous alpha-galactosidase, clears accumulated globotriaosylceramide inside lysosomes of multiple organs and relieves progressive multi-organ damage caused by Fabry disease.
Main Indications
Long-term enzyme replacement therapy for patients diagnosed with Fabry disease (alpha-galactosidase A deficiency).
Clinical Research
Global multicenter registration trials validated its therapeutic value for Fabry disease. Core efficacy trials demonstrated regular intravenous infusion could effectively reduce glycosphingolipid deposition in tissues of vital organs. Organ protection observational studies proved sustained administration slows deterioration of renal, cardiac and neurological manifestations associated with Fabry disease. Tolerability comparative research showed most mild adverse events appear during infusion and can be controlled by adjusted infusion rate and premedication. Long-term follow-up trials confirmed persistent stabilization of organ function and well-managed overall safety profile during lifelong replacement treatment.
Common Side Effects
Common mild adverse reactions: Infusion-related fever, chills, headache, nausea, vomiting and fatigue;
Laboratory abnormalities: Rare transient mild liver enzyme elevation;
Severe but uncommon risks: Severe hypersensitivity reactions, anaphylaxis and acute renal function deterioration.
Approval Status in China
REPLAGAL® (specification 3.5mg (3.5ml) per vial) obtained marketing approval in China in 2023. It is an intravenous prescription orphan drug for rare lysosomal storage disorder treatment.
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