Idarubicin Injection

Important warning:

Idarubicin injection may cause serious or life-threatening heart problems at any time during your treatment or months to years after your treatment has ended. Your doctor will order tests before and during your treatment to see if your heart is working well enough for you to safely receive idarubicin. Your doctor may tell you that you should not receive this medication if the tests show your heart's ability to pump blood has decreased. Tell your doctor if you have or have ever had any type of heart disease or radiation (x-ray) therapy to the chest area. Tell your doctor and pharmacist if you are taking or have ever received other cancer chemotherapy medications. If you experience any of the following symptoms, call your doctor immediately: shortness of breath; cough; difficulty breathing; swelling of the face, hands, feet, ankles or lower legs; weight gain (more than 5 pounds [about 2.3 kilograms] in 24 hours); dizziness; fainting; or fast, irregular, or pounding heartbeat.

Idarubicin injection may increase the risk that you will develop other cancers. Talk to you doctor about the risks of receiving idarubicin injection.

Idarubicin injection should be administered only into a vein. However, it may leak into surrounding tissue causing severe irritation or damage. Your doctor or nurse will monitor your administration site for this reaction. If you experience any of the following symptoms, call your doctor immediately: pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected.

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

Why is this medicine prescribed?

Idarubicin injection is used to treat acute myelogenous leukemia (AML; a type of cancer of the white blood cells). Idarubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of cancer cells in your body.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Idarubicin comes as a solution (liquid) to be injected intravenously (into a vein) over 10 to 15 minutes by a doctor or nurse in a medical facility. It is given once a day for 3 days. Yourdoctor will tell you how often you will receive idarubicin. Theschedule depends on the condition you have and on how your body responds to themedication

Your doctor may need to delay your treatment or adjust your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with idarubicin injection.

Askyour pharmacist or doctor for a copy of the manufacturer's information for thepatient.

What special precautions should I follow?

Before receiving idarubicin,

  • tell your doctor or pharmacist if you are allergic to thismedication, any part of this medication, or any other medications, foods orsubstances. Tell your doctor or pharmacist about the allergy and what symptomsyou had.

  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

  • tell your doctor if you have an infection, or if you have or have ever had bleeding problems, anemia (low red blood cells), low white blood cells; or kidney or liver disease.

  • tell your doctor if you or your partner are pregnant or plan to become pregnant. You or your partner should not become pregnant while you are receiving idarubicin injection. You may have to take a pregnancytest before starting treatment. You should use effective birth control toprevent pregnancy during your treatment and for 6.5 months after your finaldose. If your partner can become pregnant, use effective birth control toprevent pregnancy during your treatment and for 3.5 months after your finaldose. Talk to your doctor about what birth control would work best for you and your partner. If you or your partner become pregnant while receiving idarubicin injection, call your doctor immediately. Idarubicin may harm the fetus.

  • tellyour doctor if you are breastfeeding or plan to breastfeed. You should notbreastfeed while you are receiving idarubicin injection and for 2 weeks after your final dose.

  • you should know that idarubicin may decrease fertility in men and women. Talk to your doctor about the risks of receiving idarubicin injection.

What special dietary instructions should I follow?

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

What side effects can this medicine cause?

Idarubicin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • vomiting
  • diarrhea
  • sores in the mouth and throat
  • stomach pain
  • headache
  • hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • fever, sore throat, ongoing cough and congestion, or other signs of infection
  • unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds
  • fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain
  • hives, rash, or redness and blisters on the palms and soles of the feet

Idarubicin injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What other information should I know?

Idarubicin injection may cause your urine and other body fluids to change to a reddish color. This effect is temporary and is not harmful.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

  • Idamycin® PFS
  • also available generically
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