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Is Novantrone Right for You?

Mitoxantrone as a Disease-Modifying Therapy for Multiple Sclerosis

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Updated May 27, 2009

Novantrone (also known as mitoxantrone) is a chemotherapy that has been shown to be effective in slowing the progression of secondary-progressive MS and progressive-relapsing MS, as well as worsening relapsing-remitting MS.

This article is not about why disease-modifying therapy like Novantrone is a good idea, rather I have tried to put together as many facts as I could about the drug in plain language. Why? When I was trying to choose my treatment, I know that it was hard to find information about these drugs that was from a neutral source.

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Bottom Line: If your doc is telling you that Novantrone is your best option for slowing down the progression of your MS, the CRAB drugs (Copaxone, Rebif, Avonex and Betaseron) are probably not options. You may have already tried these drugs and found they worked for awhile (or not), but your MS has continued to progress, so it is time to switch tactics. Or, you may not have tried one of the CRAB drugs, but your neurologist feels that your MS is aggressive enough to warrant going straight to Novantrone. Tysabri might still be an option and there are factors to consider when deciding between Tysabri and Novantrone (see the full article: Tysabri vs. Novantrone: Which One Is Right For You?).

Here is the deal: We can’t overlook the fact that Novantrone is chemotherapy, plain and simple. While it has been FDA-approved for use in MS, guidelines published in 2003 by the American Academy of Neurology recommend that “because of its toxicity and the somewhat limited evidence of benefit, mitoxantrone should be reserved for patients with rapidly advancing disease who have failed other therapies.” The good news is that many people have experienced relief from rapidly-progressing symptoms – even regaining some lost function for awhile – after taking a full course of this drug.

Therefore, like many aspects of multiple sclerosis, there is not a clear answer to whether or not Novantrone is the right medication for people with certain types of MS. There are many things to consider and difficult decisions to be made. I especially want to point out that, since so many people with MS are women of childbearing age, Novantrone can make young women sterile (unable to have children) and requires careful consideration by this group for this reason. Before anyone makes the decision to seriously consider Novantrone, make sure that all of your questions are answered, your fears are addressed, your expectations are realistic. Talk to your loved ones and your physician honestly, then make your decision based on what you think is right for you.

More Details on Novantrone

Type of MS and Severity

Novantrone is used for secondary-progressive, progressive-relapsing, or worsening relapsing-remitting multiple sclerosis. It has not been approved for the treatment of primary-progressive MS. One study has shown that people older than 50, those with long-standing disability, and those with a substantial degree of atrophy of the spinal cord may be less likely to respond well to Novantrone than patients without these characteristics.

Necessary Monitoring

Blood is drawn before and after each dose. Prior to start of the treatment, a person should be carefully evaluated for any signs and symptoms of heart disease. A baseline evaluation of left ventricular ejection fraction (LVEF) should be performed before every dose of Novantrone. Novantrone treatment should be discontinued if LVEF changes significantly or is ever under 50%. It is also now recommended by the FDA that even after the course of treatment is complete, people continue to receive yearly LVEF to detect late-occurring cardiac damage.

Injection Considerations

Novantrone is given intravenously once every three months for up to two to three years only (10 or 11 doses total) in a patient’s lifetime.

Side Effects and Lifestyle

Novantrone has a number of potential side effects:
  • Heart Problems: The scariest side effect is irreversible damage to the heart, which is why there is such a strict limit on total number of doses. The most common heart-related problem is congestive heart failure, which can occur during therapy or even years after therapy with Novantrone ends.
  • Female Infertility: The majority of women stop having their periods while on Novantrone. Some women (5-30%) completing a full course of Novantrone never start their periods again and are sterile (unable to get pregnant). Recent studies demonstrate that the chance of female sterility can be lessened by the use of hormone treatment (estroprogestinic drugs) during treatment with Novantrone and this should be discussed with your doctor.
  • Leukemia: A few cases of leukemia, called acute myelogenous leukemia (AML), a type of cancer, have been reported in people taking Novantrone for MS. AML can be fatal. A 2009 Italian study of 2,854 people has shown the rate of developing leukemia to be 7.4 leukemia cases for every 1,000 patients (about 10 times higher than previously estimated). Twenty-one people in the group developed leukemia and 8 of them died.
  • Chemo Side Effects Novantrone is a chemotherapy (antineoplastic) drug, and comes with all of the potential side effects of such a drug, including nausea, hair loss (usually moderate to mild in these doses), sores in the mouth, and falling white blood cell count (leading to increased risk of infection – usually in the lungs or bladder).
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