Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.
Administration Warnings
Administer slowly into a freely running IV infusion solution. Do not administer by IM, sub-Q, intra-arterial, or intrathecal injection.
Severe local tissue necrosis if extravasation occurs. (See Local Effects under Cautions.)
Severe and sometimes irreversible neurotoxicity reported following intrathecal administration. (See Neurotoxicity under Cautions.)
Myelosuppression
Severe myelosuppression may occur. Generally avoid use in patients with baseline neutrophil count <1500/mm3, except for treatment of acute myeloid (myelogenous, nonlymphocytic) leukemia. Monitor hematologic status carefully. (See Hematologic Effects under Cautions.)
Myocardial Toxicity
Possible cardiotoxicity and potentially fatal CHF during or months to years after therapy; risk increases with increasing cumulative dose.
Risk factors (history of or current cardiovascular disease, prior or concomitant irradiation to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs) may increase risk of cardiotoxicity. However, toxicity may occur regardless of whether cardiac risk factors are present. (See Cardiotoxicity under Cautions.)
Risk of CHF developing in cancer patients is estimated to be 2.6% at cumulative dose of up to 140 mg/m2.
Prior to initiation of therapy, evaluate all patients for cardiac signs/symptoms by history and physical examination and determine baseline left ventricular ejection fraction (LVEF) by echocardiogram or multigated radionuclide angiography (MUGA).
Do not initiate therapy in patients with multiple sclerosis if baseline LVEF is <50%.
In patients with multiple sclerosis, evaluate LVEF by echocardiogram or MUGA prior to each dose; do not administer additional doses if LVEF decreases to <50% or if a clinically important reduction in LVEF occurs.
Patients with multiple sclerosis should not receive cumulative dose >140 mg/m2.
Secondary Acute Myelogenous Leukemia (AML)
Secondary AML reported in patients treated with mitoxantrone; risk of refractory secondary leukemias increases when anthracyclines are combined with other DNA-damaging antineoplastics, after extensive exposure to cytotoxic drugs, or when anthracycline doses have been escalated. (See Carcinogenicity under Cautions.)
What is this medicine?
MITOXANTRONE (MYE toe ZAN trone) is a chemotherapy drug. It targets fast dividing cells, like cancer cells, and causes these cells to die. This medicine is used to treat acute nonlymphocytic leukemia (ANLL) and advanced prostate cancer. It is also used to treat certain types of multiple sclerosis.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional. If you have pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional right away.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.
This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.
Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.
This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.
Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.
Your urine may turn blue-green for a few days after your dose. This is normal with this medicine.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Take a pregnancy test as directed before each dose of this medicine. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
breathing problems
changes in vision
chest pain
fast, irregular heartbeat
mouth sores
nausea, vomiting
pain, swelling, redness at site where injected
swelling of the ankles, feet, hands
yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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.
The Healthline Site, its content, such as text, graphics, images, search results, HealthMaps, Trust Marks,
and other material contained on the Healthline Site ("Content"), its services, and any information or material
posted on the Healthline Site by third parties are provided for informational purposes only. None of the
foregoing is a substitute for professional medical advice, examination, diagnosis, or treatment. Always seek
the advice of a physician or other qualified healthcare provider with any questions you may have regarding a
medical condition. Never disregard professional medical advice or delay in seeking it because of something you
have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or 911 immediately.
Please read the Terms of Service
for more information regarding use of the Healthline Site.
