Generic Name: Idarubicin (eye-da-ROO-bi-sin)
Trade Name: Idamycin®, Idamycin PFS®
How is this drug used? Idarubicin is FDA approved for treatment in combination with other approved products for acute myelogenous leukemia. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Idarubicin belongs to a group of drugs called anthracycline antitumor antibiotics. Idarubicin produces its anti-cancer effects by binding to DNA and inhibiting the production of proteins necessary for sustaining life of a cell.
How is idarubicin given (administered)? Idarubicin is given intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used and the overall health of the patient. If idarubicin escapes from the vein in which it is being administered, it may cause serious damage to tissues that it comes into contact with. Although patients will be monitored for this, they should tell their healthcare provider immediately if they experience pain, redness, or swelling at the site of the drug administration.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with idarubicin. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
In addition, patients treated with idarubicin will have their heart function monitored prior to treatment and at intervals during treatment as a serious side effect that damages the heart may occur.
What are the common (occur in 30% or more of patients) side effects of treatment with idarubicin?
• Low white blood cell levels – increases risk of infection
• Low red blood cell levels – increases risk of anemia
• Low platelet levels – increases risk of bleeding
• Nausea or vomiting
• Mouth sores
• Abdominal cramps
• Loss of hair
• Pain near at or near the site of drug administration
• Skin abnormalities
• Lung abnormalities
What are the less common (occur in 10% to 29% of patients) side effects of treatment with idarubicin?
• Changes in nails
• Pain, redness, swelling, rash and/or peeling of the palms of the hands or soles of the feet (hand-foot syndrome)
• Abnormalities in heart rhythm
• Abnormalities in liver function levels, as determined by blood tests
• Darkening of the skin at the site of previous radiation treatment
• Discoloration of urine (reddish)
What are the possible late side effects of treatment with idarubicin? Patients may experience a side effect that causes damage to the heart. Although rare, this side effect causes abnormalities in the way the heart pumps blood. Patients will be monitored for this side effect and should speak with their physician about this possible late side effect.
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
• Swelling of feet, ankles or face
• Yellowing of skin or eyes
• Pain, burning or blistering at the site of drug administration
• Red streaks along injected vein
• Noticeable changes in heart rate or rhythm, chest pain
• Signs of infection (redness, swelling, tenderness, pus)
• Little or no urine output for 8 to 12 hours
• Flu or cold-like symptoms – fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness
• Persistent or severe fatigue
• Difficulty breathing, shortness of breath
• Chest pain
• Unexplained or pronounced bleeding (nosebleeds, bruising, blood in the urine, black tarry stools, etc.)
• Persistant nausea or vomiting
• Mouth sores
• Numbness or tingling in hands or feet
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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