Imiglucerase

Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease.

The non-neurological manifestations of Gaucher disease include one or more of the following conditions: • anaemia after exclusion of other causes, such as iron deficiency • thrombocytopenia • bone disease after exclusion of other causes such as Vitamin D deficiency • hepatomegaly or splenomegaly

CEREZYME® (imiglucerase for injection) is indicated for: • long-term enzyme replacement therapy in patients with a confirmed diagnosis of non- neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit non- neurological manifestations of the disease.

1 Pediatrics Pediatrics (2 - 16 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Cerezyme in pediatric patients aged 2 to 16 years have been established. Therefore, Health Canda has authorized an indication for pediatric use in patients aged 2 to 16 years.

Use of Cerezyme in these age groups is supported by evidence from well-controlled studies of Cerezyme in adult and pediatric patients, with additional data obtained from the literature and from long term follow-up information.

Pediatrics (<2 years of age):

No data are available to Health Canada for pediatric patients less than 2 years of age; therefore, Health Canada has not authorized an indication for pediatric use in patients less than 2 years of age. 2 Geriatrics Geriatrics: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.