Novantrone

Mitoxantrone is used to treat leukemia and other cancers. It is also used to treat multiple sclerosis. It belongs to a class of drugs known as anthracenediones and works by slowing or stopping the growth of certain cells (including cancer cells and cells that affect the body's natural defenses).

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

This medication is given by injection into a vein by a health care professional as directed by your doctor. Dosage is based on your medical condition, body size, and response to treatment. If you are receiving this medication to treat multiple sclerosis, read the Patient Information Leaflet available from your doctor or pharmacist before starting treatment and before receiving each dose. If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelid and flush with water for 15 minutes, then seek immediate medical attention.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: natalizumab, other anti-cancer drugs (especially anthracyclines such as doxorubicin).

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Keep all regular medical and laboratory appointments.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Before using mitoxantrone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), heart disease (e.g., congestive heart failure, irregular heartbeat), liver disease, radiation treatment. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections. To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Before having surgery, tell your doctor or dentist that you are using this medication. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Before you start treatment with this medication, your doctor may direct you to have a pregnancy test. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control. This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a clinic and will not be stored at home.

See also Warning section. Nausea, vomiting, diarrhea, headache, or unusual tiredness may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly. Severe nausea, vomiting, or diarrhea may infrequently result in a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin. Temporary hair thinning/loss may occur. Normal hair growth should return after treatment has ended. This medication may cause your urine to turn blue-green. The white part of your eyes may also turn a bluish color. These effects are temporary, normal, and harmless. Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. Tell your doctor right away if you have any serious side effects, including: menstrual changes (e.g., stopped periods), unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds), numbness/tingling feelings, seizure. This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat. Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Mitoxantrone must be given only by injection into a vein. Do not give by injection into a muscle, under the skin, or into the spinal cord. If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor immediately if you notice redness, pain, or swelling at or near the injection site. This medication may infrequently result in serious (rarely fatal) heart problems (including heart failure). This effect may occur during treatment or months to years after treatment is completed. The risk of heart problems is affected by your dose, medical history (including previous heart disease, radiation treatment to the chest area, or if you have MS-multiple sclerosis), and previous use of this and other drugs (including doxorubicin or daunorubicin). Tell your doctor immediately if you notice symptoms such as irregular heartbeat, shortness of breath, sudden weight gain, or swelling ankles/feet. Very rarely, people who are treated with this type of medication have developed new cancers (e.g., secondary leukemia). The risk may be increased when this medication is given with certain anti-cancer drugs or radiation treatment. Consult your doctor for more details. Laboratory and/or medical tests (e.g., complete blood count, heart/liver function tests) should be performed before starting treatment and periodically to monitor your progress or check for side effects. Consult your doctor for more details.