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2002 Safety Alert: Cytovene IV (Ganciclovir Sodium for Injection)

February 13, 2002


This article is part of The Body PRO's archive. Because it contains information that may no longer be accurate, this article should only be considered a historical document.

This is the retyped text of a letter from Roche Laboratories. Contact the company for a copy of any referenced enclosures.

Dear Physician,

A few weeks ago, we advised you of a critical shortage of CYTOVENE-IV (ganciclovir sodium for injection) and asked that you consider alternative therapies or management strategies for your patients in order to avoid a complete out-of-stock situation.

Despite the implementation of a system to manage the available stock, demand exceeds our ability to supply Cytovene IV. Regretfully, we must inform you that will soon face a complete out-of-stock situation. While we expect to receive periodic shipments of Cytovene IV over the next few months, we may experience intermittent complete out-of-stock situations until the middle of the second quarter. We at Roche urge you to continue to explore alternative treatment therapies or management strategies for your patients.

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This temporary situation affects only the IV formulation and not the oral formulation of Cytovene (ganciclovir capsules). Please consider using the oral formulation wherever appropriate. Valcyte tablets (valganciclovir HCl) are also available for the treatment of CMV retinitis in patients with AIDS.

Roche is fully committed the prevention and treatment of CMV disease and we are working as quickly as possible to resolve the current situation.

We regret any inconvenience this situation may cause and we appreciate your patience and support as we work to meet your needs. If you have any questions or need additional information, please call the Roche professional product information department at 1-800-526-6367, Monday - Friday 8 AM - 6 PM EST.

Please see a complete Cytovene and Valcyte product information enclosed.

Sincerely,

James Thommes, M.D.
Medical Director




This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
 

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