PATIENT INFORMATION

Novantrone®

(noe-VAN-trone)

mitoXANTRONE

for injection concentrate

For Treating Multiple Sclerosis

Read this information carefully before you start taking Novantrone for multiple sclerosis (MS).  This information does not take the place of talking with your doctor.  Your doctor can tell you more about Novantrone and answer any questions you have about this treatment.  Novantrone is used for other conditions besides MS.  This leaflet has information about using Novantrone specifically for MS.

What is the most important information I should know about Novantrone?

Novantrone can reduce relapses and disability for patients with worsening forms of MS.
Novantrone may damage your heart at any time during therapy or months to years after therapy ends.  Heart damage caused by Novantrone can be serious and may cause death.  Your doctor will perform certain tests to see that your heart is working normally before you start to take Novantrone.  Your doctor will repeat these heart tests before you receive each additional dose and every year after stopping Novantrone.  Your doctor will also perform these tests if you have any symptoms of heart problems.  Because the risk to your heart may depend on the total amount of Novantrone given, your doctor will limit the number of doses you get.  Most patients will reach this limit after about 8 to 12 doses given over 2 to 3 years.  After you have reached your limit, you should not receive any additional Novantrone.  You and your doctor should both keep track of how much Novantrone you get.  (See the sections “What diagnostic tests will be performed?” and “What are the possible side effects of Novantrone?”)
MS and cancer patients treated with Novantrone have an increased risk of developing leukemia.  Your doctor should perform blood tests before, during and every year after stopping treatment.
Novantrone can increase your chance of getting an infection.  If you begin to have any signs of infection, such as fever, chills, sore throat, cough, pain with urinating, or urinating more often, call your doctor right away.  If you have such an infection, it can usually be treated by taking antibiotics.
What is Novantrone?

Novantrone is a medicine to treat MS patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting MS.  It is not for treating primary progressive MS.  Patients treated with Novantrone may have fewer relapses and keep their mobility longer.

Who should not take Novantrone?

Women who are pregnant, are trying to become pregnant, or are breastfeeding should not take Novantrone because it may harm the baby.  You should use birth control while taking Novantrone to avoid becoming pregnant.  Your doctor should also give you a pregnancy test before each dose, and you should know the results of this test before you get each dose of Novantrone.  If you plan on getting pregnant, talk with your doctor about stopping the Novantrone treatments.  If you do become pregnant, contact your doctor right away.

You should not take Novantrone if your doctor finds you have a low number of white blood cells (leukocytes).

You should not take Novantrone if your doctor finds your heart’s ability to pump blood is decreased.