Enzyme replacement therapies, Cerezyme

Dosage form Ceredase is a sterile solution for injection, supplied in 5ml bottles containing alglucerase 80 units/ml. Cerezyme is supplied as a sterile lyophilized product for injection. Each vial contains imiglucerase 212 or 424 units. Amost all patients with Gaucher s disease use Cerezyme for enzyme replacement therapy. Ceredase is only available in limited supplies for the treatment of patients who do not tolerate Cerezyme. 

Enzyme replacement is a chronic therapy that typically requires administration every week or two. Antibody response is a concern because immune reactions could produce signihcant morbidity, and mortality in rare cases. According to the manufacturer, about 15% of patients treated to date have developed IgG antibodies to Cerezyme within the hrst year, and most often within six months of initiating therapy. After 12 months of therapy, patients who do not seroconvert are less likely to develop antibodies. Nearly half of patients with detectable IgG antibodies are reported to experience some symptoms of hypersensitivity. Whether exposure of mannose on the enzyme (for targeting the enzyme to leukocytes) plays a role in eliciting or enhancing antibody response to the enzyme is not known and probably worth investigating. About 13% of patients on Ceredase also produce antibody response to the enzyme extracted from placenta. 

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