USA. Mitoxantrone (Novantrone) is approved for use in patients with secondary progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis. In the US, mitoxantrone (Novantrone) label has been revised to state that cardiac monitoring should be performed at baseline, and before every dose of mitoxantrone, in patients with multiple sclerosis receiving the drug. The revisions follow post-marketing reports that show diminished cardiac function in patients occurring early on in treatment with the product. The Boxed Warning, Warnings, and Dosage and Administration sections of the label have been revised.

Reference:

'Dear Health-care Professional' letter from Serono, April 2005 (http://www.fda.gov).