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Mitoxantrone

Medical Alert

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Warning

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 right away if you notice redness, pain, or swelling at or near the injection site.

This medication may rarely cause 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 right away if you notice symptoms such as irregular heartbeat, shortness of breath, swelling ankles/feet, unusual tiredness, or unusual/sudden weight gain.

Very rarely, people who are treated with this type of medication have developed new cancers (such as 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.

Lab and/or medical tests (such as complete blood count, heart/liver function tests, ECG) should be done before you start treatment with this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Precautions

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 (such as anemia, low blood cell counts), heart disease (such as heart failure, irregular heartbeat), liver disease, radiation treatment, recent/current infection.

Tell your health care professional that you are using mitoxantrone before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Mitoxantrone can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

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 about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using mitoxantrone. Mitoxantrone may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

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 last or get worse, tell your doctor or pharmacist promptly.

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 often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

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.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Severe nausea, vomiting, or diarrhea may rarely cause dehydration. Tell your doctor right away 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.

Tell your doctor right away if you have any serious side effects, including: menstrual changes (such as stopped periods), unusual bleeding/bruising (such as 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 sore throat that doesn't go away, fever, or chills.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.