Novantrone® (mitoxantrone)

FDA-Approved Medications: Administered by Intravenous (IV) Infusion

Company: EMD Serono, Inc.

  • Given via intravenous infusion, the dose varies according to an individual’s weight. It is administered once every three months for a maximum of two-to-three years. The total dose is limited to avoid risking damage to the heart.
  • Approved for use in SPMS, PRMS, worsening RRMS, and people who are not responding favorably to standard therapies.

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Novantrone is an immunosuppressant that has been used for many years to treat cancer. It targets rapidly dividing cells, including those believed to be involved in MS. Side effects may include cardiac disease and leukemia; patients must be closely monitored to minimize these risks. The risks of cardiotoxicity and leukemia limit the use to a maximum of two-to-three years and have dramatically reduced the use of Novantrone in the United States.

This drug appears to delay the time to a first-treated relapse, reduce the number of relapses, delay the time to disability progression, and decrease the number of new lesions that can be detected by MRI. It also appears to stabilize disease activity in some individuals with SPMS.

In June 2013, the FDA released a message regarding the potential harm that Novantrone can have on the heart’s pumping action. Individuals who have or will be taking this drug must have their heart tested before treatment and every year thereafter, even after discontinuing with Novantrone. To view the full message, please visit

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