Updated temporary treatment recommendations for Cerezyme

22 October 2009

22/10/2009 - The temporary treatment recommendations on which patients should receive Cerezyme (imiglucerase) as a priority during the shortage are as follows:

• When medically possible infants, children and adolescents should receive Cerezyme at a reduced dose or at a reduced infusion frequency, because these 'early-onset patients' may have the most rapid disease progression and are at risk of serious long-term problems. No patient should be treated at a dose lower than 15 units per kilogram body weight every two weeks or alternative treatment should be considered.
• Adult patients at high risk for the development of severe, life-threatening disease progression or pregnant women with symptomatic Gaucher disease should also receive Cerezyme at a reduced dose or at a reduced infusion frequency. Patients with such high risk include patients with one or more of the following criteria: platelet count less than 20,000 per microlitre, thrombocytopenia and bleeding, symptomatic anaemia, severe co-morbidity requiring imiglucerase treatment, such as a condition that puts a patient at risk for bleeding (for example cirrhosis, major surgery), a need for chemotherapy, lung disease caused by Gaucher cell infiltration, or new acute bone event during the last 12 months. No patient should be treated at a dose lower than 15 U/kg every two weeks, or alternative treatment should be considered.
• In patients without a high-risk for severe, life-threatening disease progression, an alternative treatment should be considered or treatment should be interrupted.
• All patients should be monitored for changes in haemoglobin, platelets and chitotriosidase levels, as appropriate, at baseline and bimonthly thereafter. Adults who demonstrate exacerbation of disease while on dose reduction/dose interruption are at high risk for the development of progressive disease or complications and should reinitiate the original treatment with Cerezyme, or alternative treatment should be considered.

Reporting of side effects will continue as normal, with doctors recording the batch numbers of the medicines in each patient's records. These are temporary recommendations and do not change the currently approved product information for this medicine. The shortage is expected to last until end of 2009.

Updated temporary treatment recommendations for Cerezyme

Reference Number: EMEA/665112/2009