--galactosidase A

【Product name】Fabrazyme

[English common name]Agalsidase beta

[Chinese common name]Galactosidase

[English name]beta-Galactosidase, Lactase, Galactosidase

[Chinese other name]--galactosidase, beta-galactosidase

[Indications] Fabrazyme is indicated for long-term enzyme replacement therapy in patients diagnosed with Fabry disease (α-galactosidase A deficiency).
Fabrazyme is suitable for adults, children and adolescents aged 8 and over.

【Usage and Dosage】 Dosimetry
The recommended dose of Fabrazyme is 1 mg / kg body weight, administered once every 2 weeks as an intravenous infusion.
Lower dosing regimens have been used in clinical studies. In one of the studies, in adult male patients, the initial dose was 1.0 mg / kg every 2 weeks, and after 6 months, 0.3 mg / kg every 2 weeks may be in some cell types in some patients. Maintenance of GL-3 clearance was maintained; however, the long-term clinical relevance of these findings has not been established.
The initial infusion rate should not exceed 0.25 mg/min (15 mg/hr) to minimize the possibility of infusion-related reactions. After establishing patient tolerance, the infusion rate can then be gradually increased following subsequent infusion.
For patients who can tolerate their infusion, consider infusing Fabrazyme at home.
The decision to transfer the patient to a home infusion should be made after the assessment
The recommendation of the attending physician. Patient experiences adverse events at home
Infusions need to stop the infusion process immediately and seek professional attention in health care. Subsequent infusions may need to be performed in a clinical setting. Dosage and infusion rates should remain the same at home, and professional care should not be changed without medical care supervision.
Special population
Renal insufficiency
Patients with renal insufficiency do not need to adjust the dose.
Liver damage
No studies have been conducted on patients with hepatic insufficiency.
elderly
The safety and efficacy of Fabrazyme in patients over 65 years of age has not been established, and no current dosing regimen is recommended in these patients.
Pediatric population
The safety and efficacy of Fabrazyme in children between 0 and 7 years of age has not been established.
The currently available data is described in sections 5.1 and 5.2, but no recommendations for posology apply to children between the ages of 5 and 7. Children from 0 to 4 years old do not have access to data. Children aged 8-16 do not need to adjust the dose.

[Storage] Store in the refrigerator (2 ° C – 8 ° C).

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