Friday, February 13, 2009

FDA Notice: CellCept

As directed, the Kidney Community Emergency Response (KCER) Coalition is providing this alert notice. Please share this information with your organization’s stakeholders, ESRD Network (facilities, patients), your State Agency contacts, and your staff. These notices will also be posted on the KCER website, http://www.kcercoalition.com/alerts.htm. Thank you!

CellCept (mycophenolate mofetil)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis
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Read the complete MedWatch 2009 Safety summary including links to the Dear Healthcare Professional and Dear Pharmacist letters, the new Medication Guide and the current Prescribing Information, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept