Idarubicin

Idarubicin is a prescription medication used treat acute myelogenous leukemia (AML). AML is a type of cancer of the white blood cells. Idarubicin belongs to a group of drugs called anthracyclines. These work by slowing or stopping the growth of cancer cells in your body.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include infection, nausea, vomiting, and hair loss.

Idarubicin is a prescription medication used treat acute myelogenous leukemia (AML). AML is a type of cancer of the white blood cells.

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

Idarubicin may be found in some form under the following brand names:

• Idamycin

Common side effects of idarubicin include:

• infection
• nausea
• vomiting
• hair loss
• stomach cramps
• diarrhea
• inflammation and sores in the mouth
• skin reactions
• fever
• headache

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• daunorubicin (cerubidine)
• doxorubicin (Doxil)
• epirubicin (Ellence)
• mitoxantrone (Novantrone)
• cyclophosphamide (Cytoxan)
• trastuzumab (Herceptin)

This is not a complete list of idarubicin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects of idarubicin include the following:

• Idarubicin 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.
• Idarubicin 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. These tests may include an electrocardiogram (ECG) and an echocardiogram. 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. If you experience any of the following symptoms, call your doctor immediately: shortness of breath; difficulty breathing; swelling of the hands, feet, ankles or lower legs; or fast, irregular, or pounding heartbeat.
• Idarubicin can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious infection or increase your risk of bleeding. If you experience any of the following symptoms, call your doctor immediately: 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.
• Tell your doctor if you have or have ever had kidney or liver disease. Your doctor may tell you that you should not receive this medication or may change your dose if you have kidney or liver disease.

Do not take this medication if you are allergic to idarubicin or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of idarubicin, there are no specific foods that you must exclude from your diet.

Before taking idarubicin,

• tell your doctor and pharmacist if you are allergic to idarubicin, any other medications, or any of the ingredients in idarubicin injection.
• 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 previously received radiation therapy or have or have ever had heart disease or if you have an infection, blood-clotting problems, or anemia (decreased amount of red blood cells in the blood).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. It is recommended to avoid pregnancy while prescribed idarubicin.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if idarubicin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using idarubicin.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

For therapy in adult patients with AML the following doses are recommended:

• 12 mg/m² daily for 3 days.
• A second course may be necessary.
• Dose adjustments may be done based on response to medication and the degree of liver and/or kidney dysfunction.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

1. Idarubicin HCl Injection should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration.
2. As is the case with other anthracyclines the use of idarubicin HCl can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have pre-existing cardiac disease.
3. As is usual with antileukemic agents, severe myelosuppression occurs when idarubicin HCl is used at effective therapeutic doses.
4. It is recommended that idarubicin HCl be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
5. Dosage should be reduced in patients with impaired hepatic or renal function