Mitoxantrone

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

What is mitoxantrone?

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 other purposes not listed in this medication guide.

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

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 receive mitoxantrone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Your 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 will need to be tested on a regular basis. Avoid being near people who have contagious illnesses. Contact 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.

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

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • prior treatment with mitoxantrone;

  • heart disease, congestive heart failure;

  • a weak immune system (bone marrow depression);

  • any type of infection;

  • a bleeding or blood-clotting disorder;

  • a blood cell disorder, such as anemia (decreased red blood cells) or decreased platelets;

  • liver disease; or
  • if you have ever been treated with daunorubicin (Cerubidine, Daunoxome) or doxorubicin (Adriamycin, Doxil).

FDA pregnancy category D. Do not use mitoxantrone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Your doctor may want you to have a pregnancy test to make sure you are not pregnant before you receive each injection of mitoxantrone.

Mitoxantrone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Using mitoxantrone can sometimes increase your risk of developing secondary types of leukemia. Talk to your doctor about your individual risk.

How is mitoxantrone given?

Mitoxantrone is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. Mitoxantrone injections are usually given once every 3 months for up to 3 years. Your dose of this medication will depend on why you are receiving it and whether it causes any harmful side effects.

Tell your caregivers if you have any burning, stinging, pain, itching, redness, bruising, or swelling around the IV needle when the medicine is injected.

Mitoxantrone may 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. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. You must remain under the care of a doctor while receiving mitoxantrone.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

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 and during your treatment with mitoxantrone. This machine measures electrical activity of the heart. This will help your doctor determine how long you can safely receive mitoxantrone.

The effects of mitoxantrone on your heart could be long-lasting. Your doctor may want to keep checking your heart function at yearly visits even after your mitoxantrone treatment ends. Do not miss any scheduled appointments.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose can cause flu-like symptoms such as fever, chills, sore throat, unusual weakness, or ongoing nausea and vomiting.

What should I avoid while receiving mitoxantrone?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Mitoxantrone side effects

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;

  • feeling short of breath, even with mild exertion;

  • swelling, rapid weight gain;

  • pain or burning when you urinate;

  • urinating more or less than usual;

  • chest pain or tightness, trouble breathing;

  • black, bloody, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds; or

  • skin changes where the medicine was injected.

Less serious side effects may include:

  • nausea, vomiting, diarrhea, constipation, stomach pain;

  • depressed mood;

  • missed menstrual periods;

  • tired feeling;

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

  • headache; or

  • thinning hair.

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.

Mitoxantrone Dosing Information

Usual Adult Dose for Acute Nonlymphocytic Leukemia:

The benefit to risk ratio of mitoxantrone in patients previously treated with daunorubicin or doxorubicin should be considered prior to treatment due to the possible additive risk of cardiotoxicity. Patients with preexisting myelosuppression as the result of prior drug therapy should not receive this drug unless the benefit exceeds the risk of further and possibly profound myelosuppression.For induction, the initial dosage of mitoxantrone recommended for this patient with acute nonlymphocytic leukemia (ANLL) is 12 mg/m2 intravenously once a day on days 1 through 3 (in combination with cytosine arabinoside for 7 days).ANLL includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias.The recommended dose of mitoxantrone may depend on whether other cytotoxic agents are coadministered. Reference to specific protocols is recommended.Most complete remissions from ANLL occur during initial induction therapy. In the event of an incomplete antileukemic response, a second induction course (usually with cytosine arabinoside) may be administered. Second inductions should be withheld until severe or life-threatening nonhematologic toxicity associated with the first induction dose is cleared. Mitoxantrone should be given for 2 days and cytarabine for 5 days using the same dosage levels.Consolidation therapy consists of mitoxantrone 12 mg/m2 given by intravenous infusion daily on days 1 and 2 (in combination with cytosine arabinoside for 5 days). The first course is given approximately 6 weeks after the final induction course, the second was generally administered 4 weeks after the first.

Usual Adult Dose for Multiple Sclerosis:

12 mg/m2 given as a short (approximately 5 to 15 minute) intravenous infusion every 3 months.Evaluation of left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan is recommended prior to administration of the initial dose of mitoxantrone.Subsequent LVEF evaluations are recommended if signs or symptoms of congestive heart failure develop, and prior to all doses administered to patients who have received a cumulative dose of 100 mg/m2 or more. Mitoxantrone should not ordinarily be administered to multiple sclerosis patients who have received a cumulative lifetime dose of 140 mg/m2 or more, or those with either an LVEF less than 50% or a clinically significant reduction in LVEF. Complete blood counts, including platelets, should be monitored prior to each course of mitoxantrone and in the event that signs or symptoms of infection develop. Mitoxantrone generally should not be administered to multiple sclerosis patients with neutrophil counts less than 1500 cells/mm3. Liver function tests should also be monitored prior to each course.

Usual Adult Dose for Prostate Cancer:

12 to 14 mg/m2 given as a short intravenous infusion every 21 days in combination with corticosteroids.

Usual Adult Dose for non-Hodgkin's Lymphoma:

8 to 10 mg/m2 given as an intravenous infusion every 21 to 28 days as a part of a combination chemotherapy regimen.

What other drugs will affect mitoxantrone?

There may be other drugs that can interact with mitoxantrone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about mitoxantrone.
  • 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.
  • 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: 4.01. Revision Date: 06/08/2009 2:39:58 PM.
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