What Is Mitoxantrone (Novantrone®)?

Reviewed by: HU Medical Review Board | Last reviewed: September 2022 | Last updated: October 2022

Mitoxantrone (Novantrone®) is a chemotherapy drug used to treat people with advanced hormone-resistant prostate cancer. This refers to prostate cancer that is at a later stage and no longer responds to hormone (anti-androgen) treatment.1

The US Food and Drug Administration (FDA) approved mitoxantrone to treat prostate cancer in 1996. Mitoxantrone is usually used in combination with steroid drugs. Serious side effects are possible. Talk to your doctor about the risks and benefits of mitoxantrone.1,2

What are the ingredients in mitoxantrone?

The active ingredient of mitoxantrone is mitoxantrone.1

How does mitoxantrone work?

Mitoxantrone is an antineoplastic drug. This means it is used to treat cancer. Cancer-fighting drugs also may be referred to as anticancer drugs, chemotherapies, or cytotoxic drugs.1-3

Mitoxantrone treats cancer by preventing cancer cells from making copies of themselves. It does this by inserting itself into DNA, which damages the DNA and prevents the cancer cells from dividing into new cells.1-3

Mitoxantrone also blocks an enzyme that cancer cells need to repair damaged DNA. When damage to DNA progresses past a certain point, cancer cells then purposefully destroy themselves.1-3

A key trait of cancer cells is uncontrolled, rapid cell division. Mitoxantrone targets this type of cell. The goal of treatment with the drug is to damage cancer cells instead of healthy cells.1,2

However, some healthy cells divide quickly and can be targeted by mitoxantrone. These include cells in the hair follicles, intestines, and blood. This explains some of the common side effects of mitoxantrone.1,2

What are the possible side effects?

The most common side effects of mitoxantrone include:1-3

  • Diarrhea
  • Hair thinning
  • Nausea
  • Constipation
  • Stomach pain
  • Fever/chills from infections
  • Mouth sores
  • Cough/sore throat from respiratory infection

Mitoxantrone has a boxed warning, the strictest warning from the FDA. It has this warning because of the risk of congestive heart failure (CHF). Mitoxantrone and certain other chemotherapies can damage your heart and cause cardiotoxicity. This makes it hard for your heart to pump blood, and it can lead to heart disease.1

CHF is serious and can be deadly. It can occur during treatment or up to years after stopping treatment. Certain factors increase the risk of CHF, including:4,5

  • Presence or history of heart problems
  • Previous treatment with similar medicines that can affect the heart
  • Higher lifetime doses of mitoxantrone
  • Previous radiation to the chest area

Mitoxantrone also has a boxed warning because it can increase your risk of developing acute myeloid leukemia (AML). Your doctor will monitor you for signs of this blood disorder. Talk to your doctor if you notice any symptoms of AML, including:1

  • Excessive bruising
  • Bleeding
  • Recurring infections

These are not all the possible side effects of mitoxantrone. Talk to your doctor about what to expect when taking mitoxantrone. Call your doctor if you have any changes that concern you when taking mitoxantrone.

Other things to know

Mitoxantrone is usually taken in combination with a steroid drug, such as prednisone, to treat prostate cancer. Prednisone helps reduce inflammation and immune system activity. This can help reduce the side effects of chemotherapy.1,2

Follow your mitoxantrone dosing schedule as your doctor prescribes. It is given as an infusion into a vein. The dosage and schedule depend on individual factors. To reduce the risk of CHF, your doctor may limit how many doses you receive.3

CHF can occur whether or not risk factors are present. Your doctor will monitor your heart before and during treatment. Talk to your doctor if you notice any symptoms of heart failure, including:4,5

  • Trouble breathing
  • Weight gain
  • Swelling of legs or ankles
  • Uneven or fast heartbeat

Mitoxantrone also can lower your white blood cell count, which can lead to infections. Your doctor will monitor your white blood cell count with blood tests. Talk to your doctor if you notice any symptoms of infections, including:1

  • Fever
  • Chills
  • Sore throat
  • Cough
  • Pain while urinating
  • Urinating more often

Before beginning treatment, tell your doctor about your full health history. Certain other health conditions and medicines may make taking mitoxantrone less safe. Tell your doctor about:

  • Other medical conditions you have, especially blood conditions and heart, liver, or kidney problems
  • All other medicines you take, including vitamins, supplements, and over-the-counter drugs
  • Any current or past infections
  • Past cancer treatments
  • Any allergies you have

For more information, read the full prescribing information.

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