OTN Mitoxantrone

In the U.S.

• Novantrone
• OTN Mitoxantrone

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Mitoxantrone injection is used alone or together with other medicines to treat advanced prostate cancer and acute nonlymphocytic leukemia (ANLL). It belongs to the group of medicines known as antineoplastics or cancer medicines. Mitoxantrone is also used to treat some forms of multiple sclerosis (MS). This medicine will not cure MS, but it may extend the time between relapses.

Mitoxantrone interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by mitoxantrone, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some unwanted effects may not occur for months or years after the medicine is used.

Before you begin treatment with mitoxantrone, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Black, tarry stools
• bladder pain
• bloody or cloudy urine
• cough or shortness of breath
• difficult, burning, or painful urination
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• frequent urge to urinate
• lower back or side pain
• pale skin
• stomach pain
• swelling or inflammation of the mouth
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

• Blood in the urine or stools
• decrease in urination
• fever or chills
• pinpoint red spots on the skin
• seizures
• sore, red eyes
• swelling of the feet and lower legs
• yellow eyes or skin

• Blue skin at the place of injection
• pain or redness at the place of injection
• skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Absent, missed, or irregular menstrual periods
• back pain
• body aches or pains
• congestion
• constipation
• diarrhea
• dryness or soreness of the throat
• hair loss
• headache
• longer or heavier menstrual periods
• nausea or vomiting
• oral bleeding
• pain or tenderness around the eyes and cheekbones
• runny nose
• sneezing
• stopping of menstrual bleeding
• stuffy nose
• tender, swollen glands in the neck
• thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.