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Drug Notebook

Generic Name: mitoxantrone

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Novantrone, Mitoxantrone Hydrochloride
An antibiotic/antineoplastic - treats Acute Nonlymphocytic Leukemia, Multiple Sclerosis, and Prostat... more
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FDA Alerts

    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.
  • 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.
  • 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 mitoxantrone 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.
  • Risk increases with increasing cumulative dose.
  • Patients with multiple sclerosis should not receive cumulative dose >140 mg/m2.
  • Risk of CHF developing in cancer patients is estimated to be 2.6% at cumulative dose of up to 140 mg/m2.
  • 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. However, toxicity may occur regardless of whether cardiac risk factors are present. (See Cardiotoxicity under Cautions.)
    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.)

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What is the most important information I should know about mitoxantrone?

Mitoxantrone should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Mitoxantrone may damage your heart at any time during therapy or months to years after therapy ends. Heart damage caused by mitoxantrone can be serious and may cause death. Your doctor will perform certain tests to see that your heart is working normally before you start to take mitoxantrone. Your doctor will repeat these heart tests before you receive each additional dose. Your doctor will also perform these tests if you have any symptoms of heart problems. Because the risk to your heart may depend on the total amount of mitoxantrone given, your doctor will limit the number of doses you get. Most patients will reach this limit after about 8 to 12 doses given over 2 to 3 years. After you have reached your limit, you should not receive any additional mitoxantrone. You and your doctor should both keep track of how much mitoxantrone you get.

In some cases, the use of mitoxantrone has been associated with the development of secondary acute leukemia. Talk to your doctor about the risks and benefits of this medication.

Serious side effects have been reported with the use of mitoxantrone including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, sore throat; or pain with urination); heart problems; acute secondary leukemia; and others. Talk to your doctor about the possible side effects from treatment with mitoxantrone.

What is mitoxantrone?

Mitoxantrone is a cancer (antineoplastic) medication. Mitoxantrone interferes with the growth of cancer cells and slows their growth and spread in the body. Mitoxantrone also affects the immune system.

Mitoxantrone is used in the treatment of prostate cancer; acute nonlymphocytic leukemia (ANLL) including myelogenous, promyelocytic, monocytic, and erythroid acute leukemias; and multiple sclerosis.

Mitoxantrone may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking mitoxantrone?

Before taking mitoxantrone, tell your doctor if you have

You may not be able to take mitoxantrone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Mitoxantrone is in the FDA pregnancy category D. This means that mitoxantrone is known to cause birth defects in an unborn baby. Do not take mitoxantrone without first talking to your doctor if you are pregnant or could become pregnant during treatment. Contraceptive measures are recommended during treatment with mitoxantrone. Mitoxantrone passes into breast milk and may harm a nursing baby. Do not take mitoxantrone without first talking to your doctor if you are breast-feeding a baby.
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Centers
·As a Drug
Acute Lymphocytic Leukemia (ALL)
Acute Myeloid Leukemia (AML)
Chronic Lymphocytic Leukemia (CLL)
Multiple Sclerosis (MS)
Prostate Cancer
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