Mitoxantrone is used to treat prostate cancer and certain types of leukemia.

Mitoxantrone is also used to treat certain types of progressive or relapsing multiple sclerosis. Mitoxantrone is not a cure for multiple sclerosis.

Mitoxantrone may also be used for purposes not listed in this medication guide.

Mitoxantrone may cause serious or fatal heart problems, even months or years after your last dose. Call your doctor at once if you have swelling in your lower legs, rapid weight gain, fast or pounding heartbeats, or shortness of breath.

Your heart function will need to be checked before, during, and after your treatment with mitoxantrone.

Mitoxantrone can also increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection, such as fever or tiredness.

Also tell your doctor if you have symptoms such as unusual weakness, bone pain, trouble breathing, night sweats, unexplained weight loss, or any skin changes or discomfort where an injection was given.

Mitoxantrone is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when mitoxantrone is injected.

Mitoxantrone may cause serious or fatal effects on your heart, even if you've never had heart problems. Your heart function will need to be checked before, during, and after your treatment with mitoxantrone. The longer you use mitoxantrone, the more likely you are to develop heart problems.

Mitoxantrone can also increase your risk of bleeding or infection. You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

For 24 hours after your injection, you may notice a blue or green discoloration of your urine or the whites of your eyes. These temporary effects are not harmful.

You must remain under the care of a doctor while receiving mitoxantrone.

You should not use mitoxantrone if you are allergic to it.

Tell your doctor about all other cancer medicines and radiation treatments you've had.

Tell your doctor if you have ever had:

• an infection, or bone marrow suppression;

• a weak immune system caused by using certain medicine;

• heart problems;

• low blood cell counts;

• liver or kidney disease; or

• radiation to your chest area.

Do not use mitoxantrone if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You may need to have a negative pregnancy test before each mitoxantrone injection.

You should not breastfeed while using mitoxantrone.

Call your doctor for instructions if you miss an appointment for your mitoxantrone injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mitoxantrone may cause dangerous effects on your heart, even months or years after you stop using mitoxantrone. Call your doctor or get medical help if you have:

• swelling in your lower legs, rapid weight gain;

• fast or pounding heartbeats; or

• shortness of breath.

Mitoxantrone may cause serious side effects. Call your doctor at once if you have:

• signs of infection--fever, unusual weakness or tiredness, night sweats, unexplained weight loss;

• unusual bruising or bleeding;

• bone pain;

• trouble breathing; or

• pain, burning, swelling, redness, bruising, or skin changes where the injection was given.

Common side effects of mitoxantrone may include:

• fever, chills, mouth sores, or other signs of infection;

• nausea, diarrhea, constipation, stomach pain;

• cold symptoms such as stuffy nose, sneezing, cough, sore throat;

• missed menstrual periods;

• hair loss; or

• blue-green colored urine or a bluish color of the whites of the eyes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect mitoxantrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.