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Novantrone

Generic Name: mitoxantrone (injectable) (mye toe ZAN trone)
Brand Names: Novantrone

What is mitoxantrone?

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

Mitoxantrone is used in the treatment of prostate cancer; acute nonlymphocytic leukemia (ANLL) including myelogenous, promyelocytic, monocytic, and erythroid acute leukemias; and multiple sclerosis.

Mitoxantrone may also be used for purposes other than those listed in this medication guide.

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

Mitoxantrone should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Mitoxantrone may damage your heart at any time during therapy or months to years after therapy ends. Heart damage caused by mitoxantrone 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 mitoxantrone. Your doctor will repeat these heart tests before you receive each additional dose. 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 mitoxantrone 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 mitoxantrone. You and your doctor should both keep track of how much mitoxantrone you get.

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In some cases, the use of mitoxantrone has been associated with the development of secondary acute leukemia. Talk to your doctor about the risks and benefits of this medication.

Serious side effects have been reported with the use of mitoxantrone including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, sore throat; or pain with urination); heart problems; acute secondary leukemia; and others. Talk to your doctor about the possible side effects from treatment with mitoxantrone.

What should I discuss with my healthcare provider before taking mitoxantrone?

Before taking mitoxantrone, tell your doctor if you have

  • had previous treatment with the cancer drugs daunorubicin (Cerubidine, Daunoxome) or doxorubicin (Adriamycin, Rubex, Doxil);

  • any type of infection;

  • liver disease;
  • had radiation (x-ray) treatment in the chest area;

  • heart disease;

  • bone marrow problems or low white or red blood cell counts; or

  • bleeding or blood clotting problems.

You may not be able to take mitoxantrone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Mitoxantrone is in the FDA pregnancy category D. This means that mitoxantrone is known to cause birth defects in an unborn baby. Do not take mitoxantrone without first talking to your doctor if you are pregnant or could become pregnant during treatment. Contraceptive measures are recommended during treatment with mitoxantrone. Mitoxantrone passes into breast milk and may harm a nursing baby. Do not take mitoxantrone without first talking to your doctor if you are breast-feeding a baby.

How should I take mitoxantrone?

Mitoxantrone should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Mitoxantrone is administered as an intravenous (into a vein) injection.

Your doctor will determine the correct amount and frequency of treatment with mitoxantrone depending upon the condition being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with mitoxantrone to monitor progress and side effects.

For the treatment of multiple sclerosis in women who could become pregnant, a pregnancy test should be performed before each dose of mitoxantrone. A negative result should be known before the medication is given.

Treatment with mitoxantrone may cause blue-green colored urine or a bluish color of the whites of the eyes for a few days after each dose. This side effect is not harmful.

Your healthcare provider will store mitoxantrone as directed by the manufacturer. If you are storing mitoxantrone, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of mitoxantrone injection.

What happens if I overdose?

If for any reason an overdose of mitoxantrone is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a mitoxantrone overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while taking mitoxantrone?

Mitoxantrone can lower the activity of the immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with mitoxantrone. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Mitoxantrone side effects

Mitoxantrone may damage your heart at any time during therapy or months to years after therapy ends. Heart damage caused by mitoxantrone 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 mitoxantrone. Your doctor will repeat these heart tests before you receive each additional dose. 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 mitoxantrone 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 mitoxantrone. You and your doctor should both keep track of how much mitoxantrone you get.

In some cases, the use of mitoxantrone has been associated with the development of secondary acute leukemia. Talk to your doctor about the risks and benefits of this medication.

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:
  • an allergic reaction (shortness of breath; closing of the throat; difficulty breathing; swelling of the lips, face, or tongue; or hives);

  • heart problems (chest pain, difficulty breathing, increased cough, swelling or water retention, or irregular heartbeats);

  • signs of infection such as fever; chills, sore throat; or pain with urination; or

  • bleeding or blood problems such as extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools.

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience:

  • nausea, vomiting, or decreased appetite;

  • loss of menstrual periods;

  • mouth sores;

  • fatigue;

  • blue-green colored urine or a bluish color of the whites of the eyes for a few days after each dose;

  • headache; or

  • hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect mitoxantrone?

Do not take mitoxantrone without first talking to your doctor if you have had previous treatment with the cancer drugs daunorubicin (Cerubidine, Daunoxome) or doxorubicin (Adriamycin, Rubex, Doxil). You may not be able to take mitoxantrone, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with mitoxantrone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with mitoxantrone.

Where can I get more information?

  • Your pharmacist has additional information about mitoxantrone written for health professionals that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 3.02. Revision Date: 4/12/2009 4:36:56 PM.
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