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Generic Name: mitoxantrone (mye-TOX-an-trone)
Brand Name: Novantrone

Novantrone is for intravenous (IV) use only. If Novantrone accidentally leaks into surrounding tissue, the skin or muscle may become severely damaged. Notify your doctor right away if burning, itching, redness, pain, swelling, or a blue discoloration of the skin at or around the injection site occurs. Novantrone must not be given through the spinal canal. There have been reports of seizures that led to coma, and paralysis with bowel and bladder problems following spinal canal administration.

Novantrone may cause severe blood disorders, such as bone marrow suppression (which decreases your body's ability to fight infection), or it may cause you to bruise or bleed easily. Certain patients who have low levels of white blood cells should not use Novantrone. Tell your doctor if you experience fever, chills, sore throat, or unusual bruising or bleeding. Your doctor will closely monitor you with lab tests, including complete blood cell counts, while you are using Novantrone.

Novantrone may cause severe and life-threatening heart problems during therapy or sometimes months to years after you receive Novantrone. Heart problems may occur even if you do not have any risk factors. Risk may increase with higher doses or prolonged use of Novantrone. Before using Novantrone, tell your doctor if you currently have heart problems or a history of heart problems, radiation treatment to the chest area, or treatment with anthracyclines (eg, doxorubicin), other similar medicines, or medicines that may cause heart problems. Talk to your doctor if you are unsure if any of your medicines may cause heart problems. Tell your doctor if you experience swelling of the hands or feet, shortness of breath, or sudden weight gain. Your doctor will closely monitor you while you are using Novantrone.

Rarely, treatment with Novantrone may result in the development of a secondary cancer. Discuss any questions or concerns with your doctor.

Novantrone is used for:

Reducing disability and the number of relapses in certain patients with multiple sclerosis. It is used along with other medicines to treat acute nonlymphocytic leukemia (ANLL) or advanced prostate cancer in certain patients. It may also be used for other conditions as determined by your doctor.

Novantrone is an antineoplastic agent. Exactly how it works is not known. It is thought to interfere with cell reproduction and growth, which helps reduce the number of cancer cells in the body.

Do NOT use Novantrone if:

  • you are allergic to any ingredient in Novantrone
  • you have multiple sclerosis along with certain heart problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Novantrone:

Some medical conditions may interact with Novantrone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have anemia, blood-clotting problems, bone marrow depression, an infection, liver problems, heart problems, gout, or unusual or unexpected bleeding
  • if you have previously received chemotherapy or have received radiation therapy in the chest area

Some MEDICINES MAY INTERACT with Novantrone. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Cyclosporine because it may increase the risk of Novantrone's side effects
  • Trastuzumab because the risk of its side effects may be increased by Novantrone
  • Digoxin or hydantoins (eg, phenytoin) because their effectiveness may be decreased by Novantrone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Novantrone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Novantrone:

Use Novantrone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Novantrone. Talk to your pharmacist if you have questions about this information.
  • Novantrone is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Novantrone at home, a health care provider will teach you how to use it. Be sure you understand how to use Novantrone. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Novantrone if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Novantrone, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Novantrone.

Important safety information:

  • Novantrone may turn your urine a blue-green color. It may also cause the whites of your eyes to turn a bluish color. This is normal and not a cause for concern.
  • Novantrone may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Do not receive a live vaccine (eg, measles, mumps) while you are using Novantrone. Talk with your doctor before you receive any vaccine.
  • Novantrone may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Some patients using Novantrone have developed a type of leukemia. Your risk may be increased if you are taking certain other cytotoxic medicines. Tell your doctor if you have a history of taking cytotoxic medicines. Discuss any questions or concerns with your doctor.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Women who may become pregnant should use an effective form of birth control while they take Novantrone. If you have questions about effective birth control, talk with your doctor.
  • Lab tests, including complete blood cell counts, liver function tests, blood chemistry, pregnancy tests, uric acid levels, and heart function tests (eg, electrocardiogram [ECG], echocardiogram), may be performed while you use Novantrone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Novantrone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Novantrone may cause harm to the fetus. Avoid becoming pregnant while you use Novantrone. If you think you may be pregnant, contact your doctor right away. Novantrone is found in breast milk. Do not breast-feed while using Novantrone.

Possible side effects of Novantrone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; blue-green urine; bluish-colored whites of the eyes; constipation; cough; diarrhea; hair loss or thinning; fatigue; loss of appetite; loss of menstrual period; menstrual changes; mouth pain or sores; nausea; stomach pain or upset; stuffy or runny nose; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dark, pink, or bloody urine; fast or irregular heartbeat; fever, chills, sore throat, or persistent cough; increased, decreased, or painful urination; mental or mood changes (eg, anxiety, depression); muscle pain, weakness, or cramping; pain, swelling, redness, or bluish color at the injection site; seizures; severe mouth pain, sores, or inflammation; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; sudden, unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; unusual skin or nail changes; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Novantrone:

Novantrone is usually handled and stored by a health care provider. If you are using Novantrone at home, store Novantrone as directed by your pharmacist or health care provider. Keep Novantrone out of the reach of children and away from pets.

General information:

  • If you have any questions about Novantrone, please talk with your doctor, pharmacist, or other health care provider.
  • Novantrone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Novantrone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Novantrone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Novantrone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Novantrone.

Issue Date: June 3, 2015