Posology : מינונים

4.2 Posology and method of administration
Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.

Posology
The recommended dose of Fabrazyme is 1 mg/kg body weight administered once every 2 weeks as an intravenous infusion.

Infusion of Fabrazyme at home may be considered for patients who are tolerating their infusions well.
The decision to have a patient move to home infusion should be made after evaluation and recommendation by the treating physician. Patients experiencing adverse events during the home infusion need to immediately stop the infusion process and seek the attention of a healthcare professional. Subsequent infusions may need to occur in a clinical setting. Dose and infusion rate should remain constant while at home, and not be changed without supervision of a healthcare professional.

Special populations
Renal impairment
No dose adjustment is necessary for patients with renal insufficiency.

Hepatic impairment
Studies in patients with hepatic insufficiency have not been performed.
Elderly
The safety and efficacy of Fabrazyme in patients older than 65 years have not been established and no dosage regimen can presently be recommended in these patients.

Paediatric population
The safety and efficacy of Fabrazyme in children aged 0 to 7 years have not yet been established.
Currently available data are described in sections 5.1 and 5.2 but no recommendation on posology can be made in children aged 5 to 7 years. No data are available in children 0 to 4 years No dose adjustment is necessary for children 8-16 years.

Method of administration
Fabrazyme should be administered as an intravenous infusion.

The initial infusion rate should be no more than 0.25 mg/min (15 mg/hour) to minimise the potential occurrence of infusion-associated reactions. After patient tolerance is established, the infusion rate may be increased gradually with subsequent infusions.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.