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mitoxantrone

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

What is mitoxantrone?

Mitoxantrone is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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 is the most important information I should know about mitoxantrone?

Mitoxantrone may cause dangerous effects on your heart. Call your doctor at once if you have chest pain, fast or pounding heartbeats, shortness of breath (even with mild exertion), swelling, or rapid weight gain.

Your heart rate may need to be checked using an electrocardiograph or ECG (sometimes called an EKG) before, during, and after your treatment with mitoxantrone. Mitoxantrone can have long lasting effects on your heart.

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Mitoxantrone can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, tired feeling, easy bruising or bleeding). Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

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

Using mitoxantrone may increase your risk of other types of cancer, such as leukemia.

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

Before you are treated with mitoxantrone, tell your doctor about all other cancer medications and treatments you have received, including radiation.

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

To make sure this medicine is safe for you, tell your doctor if you have:

  • a history of prior treatment with mitoxantrone;

  • heart disease, high blood pressure;

  • a weak immune system (bone marrow suppression);

  • any type of infection;

  • a bleeding or blood-clotting disorder;

  • a blood cell disorder, such as anemia (low red blood cells) or low levels of platelets in blood;

  • liver disease; or

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

Using mitoxantrone may increase your risk of other types of cancer, such as leukemia.

FDA pregnancy category D. 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 injection of mitoxantrone.

Mitoxantrone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using mitoxantrone.

How is mitoxantrone given?

Mitoxantrone is injected into a vein through an IV. 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 can cause serious heart damage.

Your heart rate may need to be checked using an electrocardiograph or ECG (sometimes called an EKG) before, during, and after your treatment with mitoxantrone.

Mitoxantrone can also lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

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.

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

Mitoxantrone can have long lasting effects on your heart. Your doctor may want to check 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?

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

What happens if I overdose?

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

What should I avoid while receiving mitoxantrone?

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

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.

Mitoxantrone may cause dangerous effects on your heart. Call your doctor at once if you have chest pain, fast or pounding heartbeats, shortness of breath (even with mild exertion), swelling, or rapid weight gain.

Also call your doctor at once if you have:

  • signs of infection such as fever, night sweats, sore throat, easy bruising or bleeding, loss of appetite, weight loss, bone pain, unusual weakness;

  • swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • shortness of breath (even with mild exertion);

  • swelling, rapid weight gain;

  • pain or burning when you urinate; or

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

Common side effects may include:

  • nausea, diarrhea, constipation, stomach pain;

  • hair loss;

  • missed menstrual periods;

  • runny or stuffy nose;

  • feeling tired; 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.

See also: Side effects (in more detail)

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?

Other drugs may interact with mitoxantrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.
  • 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 1996-2012 Cerner Multum, Inc. Version: 7.02. Revision Date: 2013-07-09, 9:58:56 AM.

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