IV Administration:

• Administer antihistamines, antipyretics, and/or corticosteroids prior to infusion, depending on individual status.
• Administer in a health care setting with appropriate medical monitoring and supportive measures (cardiopulmonary resuscitation equipment) available during administration.
• Intermittent Infusion: Allow refrigerated agalsidase and diluent to reach room temperature prior to reconstitution (30 min). Determine number of 35 mg and 5 mg vials needed for dose. Reconstitution: Reconstitute each vial by slowly injecting 7.2 mL and 1.1 mL of sterile water for injection into each 35-mg vial and 5-mg vial, respectively. Inject down the inside wall of vial. Roll and tilt each vial gently. Solution is clear and colorless; do not administer solutions that are discolored or contain particulate matter. Diluent: Remove an equal volume of 0.9% NaCl from a 500-mL infusion bag; then dilute further with 0.9% NaCl for a final volume of 500 mL. Inject reconstituted agalsidase directly into 0.9% NaCl; do not inject into air space. Discard unused portion of vial. Gently invert bag to mix solution, avoid vigorous shaking or agitation. Diluted solution may be filtered through an in-line low-protein-binding 0.2-micrometer filter during administration. Use reconstituted and diluted solutions immediately or within 24 hr..
• Rate: Initial infusion rate should not exceed 0.25 mg/min (15 mg/hr). Infusion rate may be slowed if infusion reaction occurs. After tolerance to rate is well established, infusion may be increased in increments of 0.05–0.08 mg/min (increments of 3–5 mg/hr) each subsequent infusion.
• Y-Site Incompatibility: Do not infuse agalsidase in the same IV line with other products.