Mitoxantrone Hydrochloride, Injection

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KEY POINTS

• This medicine is given by IV to treat multiple sclerosis and certain types of cancer.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may damage your heart or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: mitoxantrone, injection

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat certain types of cancer and multiple sclerosis. It may be given along with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems
• Bone marrow or blood disease
• Heart disease
• Kidney stones
• Liver disease
• Nerve damage or nerve pain

Tell your provider if you have recently had radiation or chemotherapy.

Tell your healthcare provider if you have any signs of infection such as cough, shortness of breath, sore throat, fever, chills, or mouth sores before or after starting this medicine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use an effective birth control method while you are taking this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine and for at least 1 month after you finish treatment.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

This is a very strong medicine. Only healthcare providers experienced with this drug should prescribe it. The infusions of this medicine are given by your healthcare provider in a clinic or hospital where you can be monitored closely. If you feel pain or burning where the infusion is being given, tell your healthcare provider right away.

This medicine needs to be given on a regular schedule. Keep all your appointments for treatments.

What should I watch out for?

This medicine may damage your heart. Talk with your healthcare provider about this. If you notice an irregular or fast heart beat, chest pain, trouble breathing, swollen feet or ankles, or any unexplained swelling, call your healthcare provider.

This medicine may increase the risk of certain types of leukemia. Talk about this with your healthcare provider.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause mouth sores. Use a soft bristle brush or mouth swab to brush your teeth.

You may need to drink more water while on this medicine, check with your healthcare provider about this.

This medicine may turn may cause your urine, sweat, saliva, or the white of your eyes to appear a blue-green color. This is normal and may last for about 24 hours after the medicine is given.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Irregular or fast heart beat; chest pain; swollen feet or ankles, or any unexplained swelling; fever; chills; sore throat; unusual bruising or bleeding; painful mouth sores that keep you from drinking fluids; severe nausea, vomiting or diarrhea; black, tarry bowel movements; pain, redness, or swelling where the IV is given; stomach pain.

Other: Mild nausea or vomiting, loss of appetite, loss of hair, body aches or pains, constipation, runny nose, irregular menstrual periods, headache, tiredness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider before taking:

• Antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Zymaxid), levofloxacin (Levaquin), and moxifloxacin (Avelox)
• Natural remedies such as echinacea, garlic, ginkgo, and ginseng
• Other cancer medicines such as daunorubicin (Cerubidine), doxorubicin (Doxil), epirubicin (Ellence), idarubicin (Idamycin), and trastuzumab (Herceptin)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.