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Idarubicin

    Brands

    DEA Class; Rx

    Common Brand Names; Idamycin

    • Antineoplastics, Anthracycline

    Anthracycline chemotherapy agent
    Used in combination with other antileukemia drugs in adults with acute myelogenous leukemia
    Cardiotoxicity and myelosuppression have been reported

    Indicated for the treatment of acute myelogenous leukemia (AML).

    For the treatment of acute promyelocytic leukemia (APL).
    For the treatment of acute lymphocytic leukemia (ALL).

    Hypersensitivity

    Serum bilirubin >5 mg/dL [>85.5 umol/L]

    • Infection (95%)
    • Nausea (30-60%)
    • Vomiting (30-60%)
    • Alopecia (25-30%)
    • Hemorrhage (63%)
    • Stomatitis (11%)
    • Fever (26%)
    • Elevated bilirubin and transaminases (20-30%)
    • Myelosuppression: > 10%
    • Seizure (4%)
    • CHF (2%)
    • Peripheral neuropathy (8%)

    Vesicant-avoid extravasation

    Risk of myocardial toxicity leading to potentially fatal CHF; 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 cardiac toxicity; benefit to risk ratio of idarubicin therapy in such patients should be weighed before starting treatment

    Monitor cardiac function during treatment in order to minimize risk of cardiac toxicity of the type described for other anthracycline compounds

    Prior radiation treatment to mediastinal-pericardial area & prior anthracyclines increases cardiotoxic risk

    Cumulative doses >150 mg/m² associated with decreased ejection fraction

    Possibility of injection site reactions

    Use caution in hepatic/renal impairment; dose reduction may be necessary

    Not for administration to patients with pre-existing bone marrow suppression induced by previous drug therapy or radiotherapy unless the benefit warrants the risk

    Due to the increased risk of cardiotoxicity, avoid concomitant use until cardiotoxic agent has been discontinued for at least 5 half-lives; specifically avoid therapy for up to 7 months after stopping trastuzumab

    Avoid pregnancy

    There is no conclusive information about therapy adversely affecting human fertility or causing teratogenesis; there has been one report of a fetal fatality after maternal exposure to drug during second trimester

    Not known whether drug is excreted in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from drug; mothers should discontinue nursing prior to taking drug and do not breastfeed during treatment and for 14 days after last dose

    Adults

    12 mg/m2 IV; maximum cumulative lifetime idarubicin dose: 150 mg/m2 IV.

    Geriatric

    12 mg/m2 IV; maximum cumulative lifetime idarubicin dose: 150 mg/m2 IV  .

    Adolescents

    Safety and efficacy have not been established. Doses up to 12 mg/m2 IV have been given off-label for AML; maximum cumulative lifetime idarubicin dose: 150 mg/m2 IV.

    Children

    Safety and efficacy have not been established. Doses up to 12 mg/m2 IV have been given off-label for AML; maximum cumulative lifetime dosage limits should be considered.

    Idarubicin hydrochloride

    injectable solution

    • 1mg/mL