Market Name: Novantrone

Generic Name: Mitoxantrone

Novantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis. Novantrone is also prescribed as initial chemotherapy for those with advanced hormone-refractory prostate cancer.

Use of Novantrone has been associated with cardiotoxicity. Cardiotoxicity can occur at any time during Novantrone therapy, and the risk increases with cumulative dose. Congestive heart failure (CHF), potentially fatal, may occur either during therapy with Novantrone or months to years after termination of therapy. All patients should be carefully assessed for cardiac signs and symptoms by history and physical examination prior to start of Novantrone therapy. A black box warning was added to Novantrone’s prescribing information by the FDA in April 2005.

Black Box Warning Date: May 2005

FDA Link: Novantrone