Safety Alerts & Recalls

What does this mean?

Due to the problem of high demand, during the current shortage, the adjusted treatment recommendations that began in October 2009 will be restarted. The adjusted treatment recommendations only apply until the 16th April.

If you receive infusions of Cerezyme, especially if you receive an adjusted dose regimen, please attend all of your doctor appointments and have your condition closely monitored. If you notice a worsening of your disease, you should contact your doctor right away and discuss your symptoms - you may need to re-start the original treatment regimen with Cerezyme or discuss alternative treatments with your doctor.

If you have any additional questions about this alert, please follow up with your doctor.

Manufacturer Announces Further Delay in Supply of Cerezyme

Genzyme, the manufacturer of Cerezyme, recently sent a letter to healthcare professionals announcing that limits on distribution of Cerezyme will be in effect until 16 April 2010. Genzyme began to distribute Cerezyme as soon as newly manufactured drug became available in early 2010. Nearly 80 percent of patients resumed normal dosing in the first weeks of 2010 creating a shipping demand that Genzyme was unable to keep up with. In order to avoid additional shipping interruptions during this time of high demand and low inventory, Genzyme will ship 50 percent of demand for an eight-week period from February 22 - through April 16, 2010.

Genzyme is continuing to produce Cerezyme. By taking this step now, Genzyme can build a level of inventory which will allow a more predictable schedule of Cerezyme delivery in the coming months and allow patients to return to normal dosing after 16 April of 2010.

Cerezyme contains the active ingredient imiglucerase and is an intravenous (IV) infusion used to treat Gaucher disease.

For more information, please visit: more information here

Source: MHRA
Publication Date: 2010-03-31
Last Updated: 2010-11-08

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