Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Date of authorisation: 17/11/1997, Revision: 32, Status: Authorised

Cerezyme is used for the long-term treatment of patients with Gaucher disease. Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called acid beta-glucosidase, which normally breaks down a fatty waste product called glucosylceramide. Without the enzyme, glucosylceramide builds up in the body, typically in the liver, spleen and bone marrow, which produces the symptoms of the disease: anaemia (low red blood cell counts), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and breaks.

Cerezyme is used in patients who have type 1 Gaucher disease, which does not affect the nerve cells, or type 3 Gaucher disease, which progresses slowly and affects the nerve cells. The patients must have symptoms that are not affecting the nervous system, including one or more of the following conditions:

• anaemia;
• thrombocytopenia (low blood platelet counts);
• bone disease;
• an enlarged liver or spleen.

The medicine can only be obtained with a prescription.