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Fabrazyme Supply

EUROPEAN MEDICINES AGENCY GIVES NEW TEMPORARY TREATMENT RECOMMENDATIONS FABRAZYME - Supply shortages for Fabrazyme to last longer than expected

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has been informed by Genzyme that the supply shortages for Fabrazyme are expected to continue at least until the end of September 2010, because of a new manufacturing problem.

For Fabrazyme, the Committee decided to revise the recommendations made on 25 September 2009, since, based on information supplied by Genzyme, at least 12% of patients on the reduced Fabrazyme dose regimen have already experienced a worsening of their disease. For such patients, the CHMP has recommended that physicians should either consider restarting the original treatment with the full dose of Fabrazyme or switching to an alternative treatment, such as Replagal.

Given the new information, the temporary treatment recommendations for Fabrazyme are as follows:

•          Children and adolescents (under 18 years) should receive Fabrazyme according to the standard dose (1.00mg/kg) and frquency of one infusion every two weeks.

•          Adult patients already treated / stabilised may receive Fabrazyme with an adjusted dose of 0.3mg/kg as a maintenance dose every two weeks.

•          All patients, especially those with adjusted dose regimens, should be under close clinical surveilannce.

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.

•          For patients on the reduced dose who demonstrate a deterioration of the disease, physicians should consider restarting the original treatment with the full dose of Fabrazyme or switching to an alternative treatment, such as Replagal.

These recommendations are temporary and do not change the currently approved product information for Fabrazyme.

Read the full press release...