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Mitoxantrone Hydrochloride Solution for injection

It targets fast dividing cells, like cancer cells, and causes these cells to die

Generic Name: mitoxantrone

Brand Names: Mitoxantrone Hydrochloride, Novantrone

There is an FDA Alert for this drug. Click here to view it.

    Experience of Supervising Clinician
  • 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.)
  • 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.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • heart disease
  • infection (especially virus infection such as chickenpox or herpes)
  • liver disease
  • low blood counts, like low platelets, red blood cells, white blood cells
  • previous chemotherapy, especially with doxorubicin, daunorubicin, epirubicin, or idarubicin
  • recent or ongoing radiation therapy
  • an unusual or allergic reaction to mitoxantrone, other medicines, foods, dyes, or preservatives
  • pregnant or are trying to get pregnant
  • breast-feeding

How should I use this medicine?

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.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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.

What may interact with this medicine?

  • ciprofloxacin
  • cyclosporine
  • medicines to increase blood counts like filgrastim, pegfilgrastim, sargramostim
  • other chemotherapy drugs like daunorubicin, doxorubicin, epirubicin, idarubicin, trastuzumab
  • vaccines

Talk to your doctor or health care professional before taking any of these medicines:

  • acetaminophen
  • aspirin
  • ibuprofen
  • ketoprofen
  • naproxen

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.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

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.

Last Updated: November 30, 2009
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