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U.S. Department of Health and Human Services

Safety

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Novantrone (mitoxantrone for injection concentrate)

Audience: Neurologists, oncologists, cardiologists, and consumers

Serono and FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Novantrone [mitoxantrone], indicated for treatment of multiple sclerosis (MS). The Dear Healthcare Professional letter provides additional information concerning the risks of cardiotoxicity associated with Novantrone and also provides supplemental information regarding secondary acute myelogenous leukemia (AML) reported in MS patients treated with Novantrone.

[April, 2005 - Dear Healthcare Professional Letter - Serono]

[March, 2005 - Patient Information - Serono]