Advertisement
Advertisement
Fabrazyme

Fabrazyme Dosage/Direction for Use

agalsidase beta

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Recommended Dose: The recommended dosage of Fabrazyme is 1 mg/kg body weight infused every two weeks as an intravenous (IV) infusion. Patients should receive antipyretics prior to infusion (see PRECAUTIONS).
The initial IV infusion rate should be no more than 0.25 mg/min (15 mg/hr). The infusion rate may be slowed in the event of infusion reactions. After patient tolerance to the infusion is well established, the infusion rate may be increased in increments of 0.05 to 0.08 mg/min (increments of 3 to 5 mg/hr) with each subsequent infusion. For patients weighing <30 kg, the maximum 308 infusion rate should remain at 0.25 mg/min (15 mg/hr). For patients weighing ≥30 kg, the administration duration should not be less than 1.5 hours (based on individual patient tolerability).
Patients who have had a positive skin test to Fabrazyme or who have tested positive for anti-Fabrazyme IgE may be successfully re-challenged with Fabrazyme. The initial re-challenge administration should be a low dose at a lower infusion rate, e.g., 1/2 the therapeutic dose (0.5 mg/kg) at 1/25 the initial standard recommended rate (0.01 mg/min). Once a patient tolerates the infusion, the dose may be increased to reach the approved dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards (doubled every 30 minutes up to a maximum rate of 0.25 mg/min), as tolerated.
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement