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Medications and Drugs

Brand Names: Novantrone

Generic Name: mitoxantrone (Pronunciation: mye toe ZAN trone)

What is mitoxantrone (Novantrone)?

Mitoxantrone is a cancer medication that interferes with cancer cells and slows their growth and spread in the body. Mitoxantrone also affects the immune system.

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

Mitoxantrone is also used to treat the symptoms of relapsing multiple sclerosis. This medication will not cure multiple sclerosis.

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

What are the possible side effects of mitoxantrone (Novantrone)?

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

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, mouth sores, unusual weakness;
  • pain or burning when you urinate;
  • fast, slow, or uneven heart rate;
  • severe or ongoing nausea or diarrhea;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds; or
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • urinating more or less than usual;
  • chest pain or tightness, trouble breathing;
  • skin changes where the medicine was injected.

Less serious side effects may include:

  • mild nausea, mild diarrhea, constipation;
  • heartburn, stomach pain;
  • hair loss;
  • heavy menstrual bleeding;
  • missed menstrual periods;
  • runny nose;
  • tired feeling;
  • depressed mood; or
  • blue-green colored urine or a bluish color of the whites of the eyes for a few days after each dose.

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.

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

You should not use this medication if you are allergic to mitoxantrone.

Before receiving this medication, tell your doctor if you have ever received it in the past, or if you have heart disease, congestive heart failure, a weak immune system, any type of infection, a bleeding or blood-clotting disorder; a blood cell disorder, liver disease, or if you have ever been treated with daunorubicin (Cerubidine, Daunoxome) or doxorubicin (Adriamycin, Rubex, Doxil).

Do not use mitoxantrone if you are pregnant. It could harm the unborn baby. You may need a pregnancy test to make sure you are not pregnant before you receive each injection of mitoxantrone.

Mitoxantrone can cause your urine to turn a blue-green color. You may also notice a bluish discoloration of the whites of your eyes. This side effect should last only a few days and is not harmful.

Mitoxantrone can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Mitoxantrone can also cause serious heart damage. Your heart rate will need to be checked using an electrocardiograph or ECG (sometimes called an EKG) before, during, and after your treatment with mitoxantrone. Do not miss any scheduled appointments. The effects of mitoxantrone on your heart could be long-lasting.

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

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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