Cerezyme Special Precautions

Hypersensitivity: Current data using a screening ELISA followed by a confirmatory radioimmunoprecipitation assay, suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed in approximately 15% of the treated patients. It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy. It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase.
Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions (see Adverse Reactions). If a patient experiences a reaction suggestive of hypersensitivity, subsequent testing for imiglucerase antibodies is advised. As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible, but occur uncommonly. If these reactions occur, immediate discontinuation of the Cerezyme infusion is recommended and appropriate medical treatment should be initiated. The current medical standards for emergency treatment are to be observed.
Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase (alglucerase) should be treated with caution when administering Cerezyme (imiglucerase).
Excipients: This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see Special Precautions for Disposal and Other Handling under Cautions for Usage). To be taken into consideration by patients on a controlled sodium diet.
Effects on Ability to Drive and Use Machines: Cerezyme has no or negligible influence on the ability to drive and use machines.