Fabrazyme Dosage/Direction for Use

Recommendations Prior to FABRAZYME Treatment: Administration of FABRAZYME should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions].
Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment [see Precautions].
Prior to FABRAZYME administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids [see Precautions].
FABRAZYME must be reconstituted and diluted prior to use [see Dosage & Administration].
Recommended Dosage: The recommended dosage of Fabrazyme is 1.0 mg/kg body weight infused every two weeks as an IV infusion. Patients should receive antipyretics prior to infusion [see Infusion-Associated Reactions under 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 3.0 to 5.0 mg/hr) with each subsequent infusion. For patients weighing <30 kg, the maximum infusion rate should remain at 0.25 mg/min (15.0 mg/hr). For patients weighing ≥30 kg, the administration duration should not be less than 1.5 hours (based on individual patient tolerability).
Rechallenge Instruction: 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 1.0 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.