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 can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, tiredness).

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.

Seek medical attention right away if you have chest pain, irregular heartbeats, shortness of breath, swelling, or rapid weight gain.

Idarubicin is given as an infusion into a vein. A healthcare provider will give you this injection.

Idarubicin is usually given together with other cancer medicines. You may be given other medications to prevent nausea, vomiting, or infections.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when idarubicin is injected.

If any of this medication accidentally gets on your skin, wash it thoroughly with soap and warm water.

Idarubicin can increase your risk of bleeding or infection. You will need frequent medical tests. Your liver, kidney, and heart function may also need to be checked.

Usual Adult Dose for Acute Myeloid Leukemia:

12 mg/m2 daily for 3 days by slow (10 to 15 min) IV administration in combination with cytarabine
Maximum recommended cumulative lifetime dose for the IV formulation: 150 mg/m2

In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered.

Comment:
-Administration of the second course should be delayed in patients who experience severe mucositis until recovery has occurred, and a dose reduction of 25% is recommended.

Use: For the treatment of acute myeloid leukemia (AML) in combination with other approved antileukemic drug (including French-American-British [FAB] classifications M1 through M7)

Usual Adult Dose for Acute Nonlymphocytic Leukemia:

12 mg/m2 daily for 3 days by slow (10 to 15 min) IV administration in combination with cytarabine
Maximum recommended cumulative lifetime dose for the IV formulation: 150 mg/m2

In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered.

Comment:
-Administration of the second course should be delayed in patients who experience severe mucositis until recovery has occurred, and a dose reduction of 25% is recommended.

Use: For the treatment of acute myeloid leukemia (AML) in combination with other approved antileukemic drug (including French-American-British [FAB] classifications M1 through M7)

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 idarubicin.

• 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.

Call your doctor for instructions if you miss an appointment for your idarubicin injection.

Since idarubicin is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Unless your doctor tells you otherwise, continue your normal diet.

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.

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.

Idarubicin may cause serious side effects. 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 of idarubicin 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.

Tell your doctor about all other cancer medicines you have received in the past 7 months, especially:

• cyclophosphamide;

• paclitaxel; or

• trastuzumab.

This list is not complete. Other drugs may affect idarubicin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to idarubicin.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.