Mitoxantrone Hydrochloride Solution for injection

What is this medicine?

MITOXANTRONE (MYE toe ZAN trone) is a chemotherapy drug. It targets fast dividing cells, like cancer cells, and causes these cells to die. This medicine is used to treat acute nonlymphocytic leukemia (ANLL) and advanced prostate cancer. It is also used to treat certain types of multiple sclerosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• infection (especially virus infection such as chickenpox or herpes)

• liver disease

• low blood counts, like low platelets, red blood cells, white blood cells

• previous chemotherapy, especially with doxorubicin, daunorubicin, epirubicin, or idarubicin

• recent or ongoing radiation therapy

• an unusual or allergic reaction to mitoxantrone, other medicines, foods, dyes, or preservatives

• pregnant or are trying to get pregnant

• breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional. If you have pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional right away.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• ciprofloxacin

• cyclosporine

• medicines to increase blood counts like filgrastim, pegfilgrastim, sargramostim

• other chemotherapy drugs like daunorubicin, doxorubicin, epirubicin, idarubicin, trastuzumab

• vaccines

Talk to your doctor or health care professional before taking any of these medicines:

• acetaminophen

• aspirin

• ibuprofen

• ketoprofen

• naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Your urine may turn blue-green for a few days after your dose. This is normal with this medicine.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Take a pregnancy test as directed before each dose of this medicine. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

There is a maximum amount of this medicine you should receive throughout your life. The amount depends on the medical condition being treated and your overall health. Your doctor will watch how much of this medicine you receive in your lifetime. Tell your doctor if you have taken this medicine before.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

• breathing problems

• changes in vision

• chest pain

• fast, irregular heartbeat

• mouth sores

• nausea, vomiting

• pain, swelling, redness at site where injected

• swelling of the ankles, feet, hands

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• blue color in the whites of your eyes

• constipation

• diarrhea

• hair loss

• loss of appetite

• missed menstrual periods

• nail discoloration or damage

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.