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Generic Name: mitoxantrone

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An antibiotic/antineoplastic - treats Acute Nonlymphocytic Leukemia, Multiple Sclerosis, and Prostat... more

FDA Alerts: Special Alerts:

[Posted 07/29/2008] FDA reminded health care professionals who treat patients with mitoxantrone (Novantrone) about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug.

These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mitoxantrone and http://www.fda.gov/cder/drug/InfoSheets/HCP/mitroxantroneHCP.htm.
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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.

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Related Learning
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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