- Solution for injection 1 mg/mL
Idarubicin is a DNA-intercalating analog of daunorubicin, which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II.
Approximately 97% is protein bound, 94% (active metabolite).
The major metabolite is idarubicinol (active metabolite). Extensive extra hepatic metabolism.
The t 1/ 2 is approximately 22 h. The t 1/ 2 is at least 45 h (active metabolite). Primarily excreted by biliary and, to a lesser extent, by renal excretion.
Special PopulationsRenal Function Impairment
Possible impaired metabolism and the disposition also may be affected. Consider dose reduction.Hepatic Function Impairment
Possible impaired metabolism and the disposition may also be affected. Consider dose reduction.
Indications and Usage
Acute myelocytic leukemia as part of a combination chemotherapy regimen.
Dosage and AdministrationAdults
IV Induction therapy in combination with other chemotherapeutic drugs : Idarubicin 12 mg/m 2 /day for 3 days by slow (10 to 15 minutes) IV injection in combination with cytarabine; may give second course if needed. Reduce dosage of subsequent courses 25% in patients experiencing severe mucositis. Delay therapy until recovery from mucositis occurs.
- Diligently follow institutional and NIH procedures for handling, administration, and disposal of anticancer drugs. Wear appropriate protective equipment when preparing and administering idarubicin. Avoid exposure by direct contact of the skin, mucous membranes, and eyes.
- If accidental skin or mucus membrane contact occurs, wash thoroughly with soap and water. If accidental eye contact occurs, immediately institute standard irrigation techniques.
- Do not administer if particulate matter or cloudiness is noted. Solution has a red-orange color which is normal and of no concern.
- Administer prescribed dose slowly (over 10 to 15 minutes) into freely flowing IV infusion of 0.9% sodium chloride injection or 5% dextrose in water injection. Attach tubing to butterfly needle or other suitable device and insert into large vein. Take precautions to avoid extravasation.
- Discard unused portions of vial. Do not save any unused portions for future use.
- Do not mix with any other medications. Flush infusion line with D5W or 0.9% sodium chloride injection prior to administration of any concomitant medication.
Store vials in refrigerator (36° to 46°F). Protect from light. Retain in original carton until time of use.
None well documented.
Laboratory Test Interactions
None well documented.
CHF; serious arrhythmias (including atrial fibrillation); chest pain; MI; asymptomatic declines in left ventricular ejection fraction.
Headache (20%); neurologic involvement of peripheral nerves (7%); seizure (4%).
Hair loss (77%).
Nausea/vomiting (82%); abdominal cramps/diarrhea (73%); mucositis (50%); severe enterocolitis with perforation (rare).
Severe changes in renal function (1% or less).
Hemorrhage (63%); myelosuppression.
Changes in hepatic functions (less than 5%).
Pulmonary allergy (2%).
Infection (95%); fever (26%).
WarningsIV use only
Do not administer IM or subcutaneously.Extravasation
Local irritation or phlebitis may occur. Refer to your institution-specific protocol. Give idarubicin slowly into a freely flowing IV infusion; never give IM or subcutaneously. Extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If signs or symptoms of extravasation occur, terminate the injection or infusion immediately and restart in another vein. Monitor IV infusion site for signs or symptoms of extravasation. If noted, immediately discontinue infusion and restart in another vein. Be prepared to treat extravasation site with intermittent ice packs ( 1/ 2 h immediately, then 1/ 2 h 4 times daily for 3 days) and extremity elevation. Frequently examine extravasation site and immediately inform health care provider if pain, erythema, edema, or vesiculation is noted or if patient reports persistent pain.Myocardial toxicity
Idarubicin can cause myocardial toxicity, leading to potentially fatal CHF, acute life-threatening arrhythmias, or other cardiomyopathies. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have preexisting cardiac disease.Myelosuppression
Severe myelosuppression occurs in all patients when idarubicin is used at therapeutic doses for induction, consolidation, or maintenance.
Category D .
Undetermined. Discontinue nursing prior to taking this drug.
Safety and efficacy not established.
Hepatic/Renal function impairment
Reduce dosage in patients with impaired hepatic or renal function. Do not administer if the bilirubin level is more than 5 mg/dL.
Bone marrow suppression
Idarubicin is a potent bone marrow suppressant. Do not give to patients with preexisting bone marrow suppression induced by previous drug therapy or radiotherapy unless the benefit warrants the risk.
Pre-existing heart disease and previous therapy with anthracyclines at high cumulative doses or other potentially cardiotoxic agents are co-factors for increased risk of idarubicin-induced cardiac toxicity.
Idarubicin can cause severe local tissue necrosis, which may occur with or without accompanying stinging or burning sensation.
Severe and prolonged myelosuppression. Possibly increased severity of GI toxicity.
- Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
- Advise patient, family, or caregiver that medication will be used in combination with other agents to achieve max benefit possible.
- Review dosing schedule with patient, family, or caregiver.
- Advise patient, family, or caregiver that medication will usually cause a red coloration of the urine. Advise that this is not a problem and is expected because the medication is being eliminated in the urine.
- Advise patient, family, or caregiver that medication may cause hair loss but that this is reversible when therapy is stopped.
- Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; hives; difficulty breathing; chest pain; fever, chills or other signs of infection; sores in mouth; unusual bleeding or bruising; pain, redness, or swelling at injection site.
- Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting, diarrhea, or appetite loss; persistent or worsening general body weakness.
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