Supply problems which were discussed in the communiqué of 06/07/2009 concerning Cerezyme and Fabrazyme, as well as the communiqués of 18.08.2009 and 6.11.2009 concerning Cerezyme, are not yet fully resolved. The manufacturer Genzyme has updated the information relating to these supply problems and recommendations are made.
Concerning Cerezyme (used in patients with Gaucher’s disease, a disease in which patients do not have enough of an enzyme called alglucerase):
In the first weeks of 2010 nearly 80 percent of patients received normal dosing.
Cerezyme production is continuing successfully. However because of the high demand and low inventory, Genzyme will ship 50 percent of demand for an eight-week period from 22nd February through to 16th April 2010 in order to build a sufficient level of inventory for an adequate supply from 16th April 2010.
During this period of restriction treatment recommendations issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) and published on our website on 06.11.2009 are applicable until 16th April 2010.
Concerning Fabrazyme (used in patients with Fabry’s disease, a disease in which patients do not have enough of an enzyme called alpha-galactosidase A):
Healthcare professionals were recommended to reduce the dose in adult patients to meet a 30 percent supply allocation until end of the first quarter of 2010
Unfortunately the firm Genzyme were not able to produce the expected amounts of Fabrazyme and have to extend the period of supply restriction until the end of June 2010.
During this period treatment recommendations provided by the EMEA on 25/09/2009 still apply:
- Children and adolescents (
- Adult male patients and adult female patients already treated/stabilised may receive Fabrazyme with an adjusted dose of 0.3 mg/kg as a maintenance dose every two weeks.
- Patients with adjusted dose levels should be kept under close clinical surveillance. A full medical examination, including all relevant clinical parameters, should be performed every two months. It is of the utmost importance to monitor the plasma GL-3 or urinary GL-3 levels, as for the moment the GL-3 level is the most sensitive parameter. Patients who show a deterioration of disease should reinitiate the original treatment with Fabrazyme.
Adverse events should continue to be reported as usual and physicians are reminded to document batch numbers in the patient record.