Novantrone (mitoxantrone hydrochloride)

Novantrone® (mitoxantrone hydrochloride) is a synthetic anticancer agent for intravenous use. Novantrone is approved to treat reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary progressive multiple sclerosis (SPMS) or worsening relapsing-remitting multiple sclerosis (RRMS). Novantrone is not indicated for treatment of primary progressive multiple sclerosis.¹

What are the ingredients in Novantrone?

The active ingredient in Novantrone is mitoxantrone hydrochloride.¹

How does Novantrone work?

Novantrone is a chemotherapy medication used as a disease-modifying drug (DMD) to reduce the number of MS relapses. It suppresses the body's immune system during treatment and depletes the number of cells that attack myelin around the nerves.¹

What are the possible side effects?

Many clinical trials evaluated the safety and efficacy of Novantrone. The most common side effects experienced by those taking Novantrone include:¹

• Nausea and vomiting
• Hair thinning
• Loss of menstrual periods
• Bladder infections
• Mouth sores
• Headache

If you have trouble breathing, experience swelling of legs or ankles, or uneven or fast heartbeat, call 911 immediately. These problems generally happen in people who receive a lifetime dose of more than 12 doses but can also occur at lower lifetime doses.¹

Novantrone has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because it can cause life-threatening heart problems. Your doctor will assess your heart function before you begin treatment with Novantrone, before each infusion, and for a time after your last dose.¹

Novantrone may reduce white blood cell count, which increases the chance of getting an infection. It may also cause your platelet count to go down, which increases the chance of bleeding. This is why regular blood tests are conducted. Call the doctor if you experience fever, chills, sore throat, cough, pain with urination, urination more often, or if you notice any unusual bleeding or bruising.¹

These are not all the possible side effects of Novantrone. Talk to your doctor about what to expect when taking Novantrone. You also should call your doctor if you have any changes that concern you when taking Novantrone.

Other things to know about Novantrone

People with MS may experience changes in heart function when treated with Novantrone. Before starting therapy, everyone should have a cardiac assessment including taking a history, physical examination, ECG, and quantitative LVEF (left ventricular ejection fraction) evaluation. People with a baseline LVEF below the lower limit of normal should not be treated with Novantrone.¹

A complete blood count, including platelets and liver function tests, should be obtained prior to each course of Novantrone and if signs of infection develop.¹

Novantrone and its metabolites are excreted in the bile and urine. It may cause a blue-green color to the whites of your eyes (sclera) and the urine for 24 hours after administration.¹

Before starting Novantrone, talk with your doctor if you have:¹

• A preexisting myelosuppression (reduction of bone marrow activity) as the result of prior drug therapy
• Been treated with certain medications that can affect cardiac toxicity
• Leukemia
• Abnormal liver function
• A plan to become pregnant, as Novantrone may harm unborn babies
• A history of hypersensitivity or allergic reaction to mitoxantrone hydrochloride

Before beginning treatment for MS, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For additional details, read the full prescribing information of Novantrone.