Fabrazyme Caution For Usage

Instructions for Use/Handling: Fabrazyme does not contain any preservatives. Vials are for single-use only. Discard any unused product.
Avoid shaking or agitation of this product. Do not use filter needles during the preparation of the infusion.
Reconstitution and Dilution: Using Aseptic Technique.
1. Allow Fabrazyme vials and diluent to reach room temperature prior to reconstitution (approximately 30 minutes). The number of 35 mg and 5 mg vials needed is based on the patient's body weight (kg) and the recommended dose of 1.0 mg/kg.
Select a combination of 35 mg and 5 mg vials so that the total number of mg is equal to or greater than the patient's number of kg of body weight.
2. Reconstitute each 35 mg vial of Fabrazyme by slowly injecting 7.2 mL of Sterile Water for Injection, USP down the inside wall of each vial. Roll and tilt each vial gently. Each vial will yield a 5.0 mg/mL clear, colorless solution (total extractable amount per vial is 35 mg, 7.0 mL).
Reconstitute each 5 mg vial of Fabrazyme by slowly injecting 1.1 mL of Sterile Water for Injection, USP down the inside wall of each vial. Roll and tilt each vial gently. Each vial will yield a 5.0 mg/mL clear, colorless solution (total extractable amount per vial is 5 mg, 1.0 mL).
3. Visually inspect the reconstituted vials for particulate matter and discoloration. Do not use the reconstituted solution if there is particulate matter or if it is discolored.
4. The reconstituted solution should be further diluted with 0.9% Sodium Chloride Injection, USP to total volume based on patient weight specified in Table 4. Prior to adding the volume of reconstituted Fabrazyme required for the patient dose, remove an equal volume of 0.9% Sodium Chloride for Injection, USP from the infusion bag. (See Table 4.)

Click on icon to see table/diagram/image

Slowly withdraw the reconstituted solution from each vial up to the total volume required for the patient dose. Inject the reconstituted Fabrazyme solution directly into the Sodium Chloride solution. Do not inject in the airspace within the infusion bag. Discard any vial with unused reconstituted solution.
5. Gently invert infusion bag to mix the solution, avoiding vigorous shaking and agitation.
6. Do not infuse Fabrazyme in the same intravenous line with other products.
7. Administer FABRAZYME using an in-line low protein-binding 0.2 μm filter.