Idarubicin is used in combination chemotherapy in adults to treat acute myeloid leukemia (AML), a type of blood cancer.

Idarubicin may also be used for purposes not listed in this medication guide.

Idarubicin may cause dangerous effects on your heart, especially if you have heart problems, if you have received certain cancer drugs in the past, or if you are over 60.

Tell your doctor if you have ever had:

• heart problems;
• radiation treatment;
• chemotherapy with doxorubicin, daunorubicin, epirubicin, idarubicin, or mitoxantrone;
• bone marrow suppression;
• liver or kidney disease;
• gout;
• anemia (low red blood cells); or
• sepsis (a severe reaction to an infection).

Idarubicin can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6.5 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3.5 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 14 days after your last dose.

Use Idamycin PFS (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Idarubicin may cause dangerous effects on your heart. Tell doctor right away if you have chest pain, shortness of breath (even with mild exertion), swelling, or rapid weight gain.

Call your doctor at once if you have:

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• irritation or skin changes where the injection was given;
• pain, blisters, bleeding, or severe rash on the palms of your hands or the soles of your feet;
• sores or white patches in or around your mouth; or
• severe nausea, vomiting, stomach cramps, or diarrhea.

Common side effects may include:

• nausea, vomiting, stomach pain, diarrhea;
• mouth sores;
• bleeding;
• headache;
• rash; or
• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.