Class: Chemotherapy

Generic Name: Mitoxantrone (mye-toe-ZAN-trone), DHAD
Trade Name: Novantrone®

How is this drug used? Mitoxantrone is FDA approved for the treatment of advanced prostate cancer in combination with corticosteroids, and in combination with other agents for the treatment of acute nonlymphocytic leukemia. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Mitoxantrone belongs to a group of agents called antitumor antibiotics.  Antitumor antibiotics produce their anti-cancer effects by binding to DNA and inhibiting the production of proteins necessary for sustaining the life of a cell.

How is mitoxantrone given (administered)? Mitoxantrone is given into a vein (intravenous), and the dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used, and the overall health of the patient. Mitoxantrone may cause inflammation of the vein into which it is administered or any surrounding tissue. Skin may also turn blue in the area surrounding where the drug was administered. Although patients will be monitored for this, they should tell their healthcare provider if they experience pain, redness or swelling at the site of administration.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with mitoxantrone.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

Patients will also have their heart function monitored, as an uncommon but serious side effect of treatment with mitoxantrone is an abnormality in the pumping action of the heart. Heart damage may occur during therapy or months to years after therapy ends. Heart damage can be serious and may cause death. The risk increases with cumulative dosing.

Patients with blood cancers will also be monitored for the development of a condition called tumor lysis syndrome in which electrolyte and metabolic disturbances occur.  Tumor lysis syndrome can be prevented if managed aggressively at the beginning of treatment.  Blood tests will measure levels of electrolyte and metabolic products, and patients should contact their healthcare provider if they experience symptoms such as nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.

What are the common (occur in 30% or more of patients) side effects of treatment with mitoxantrone?

• Low white blood cell levels – increases the risk of infection
• Low red blood cell levels – increases the risk of anemia and blood transfusions
• Low platelet levels – increases the risk of bleeding
• Abnormalities in liver function levels, as determined by blood tests
• Nausea and vomiting

What are the less common (occur in 10% to 29% of patients) side effects of treatment with mitoxantrone?

• Fever
• Diarrhea
• Constipation
• Mouth sores
• Loss of appetite
• Generalized weakness
• Loss of hair
• Abnormalities in heart rhythm
• Reduced blood pressure
• Discoloration of urine (bluish/greenish)
• Discoloration of whites of eyes (bluish/greenish)
• Cough, shortness of breath

What are the possible late side effects of treatment with mitoxantrone? Patients treated with mitoxantrone are at a slightly increased risk of developing a secondary malignancy. A secondary malignancy is a new and unrelated cancer that occurs in an individual as a result of previous treatment with radiation or chemotherapy.  Patients should ask their physician about the possibility of developing a secondary malignancy as a result of their treatment.  In addition, damage to the heart, which inhibits proper pumping action, may occur with the use of mitoxantrone, although this is uncommon.

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Chest pain
• Noticeable changes in heart rate or rhythm
• Lightheadedness or dizziness
• Swelling of ankles or feet
• Sudden weight gain
• Difficulty breathing
• Flu or cold-like symptoms – fever, sore throat, cough, chills
• Signs of infection – redness, swelling, pus, tenderness
• Painful urination
• Persistent or severe fatigue
• Unexplained or pronounced bleeding (nosebleeds, bruising, blood in the urine, black tarry stools, etc.)
• Persistent or extreme nausea or vomiting
• Yellowing of the skin or eyes
• Persistent or extreme diarrhea
• Mouth sores
• Burning, pain, redness or swelling at the injection site

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 07/10.

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