Classes
DEA Class; Rx
Common Brand Names; Idamycin
- Antineoplastics, Anthracycline
Description
Anthracycline chemotherapy agent
Used in combination with other antileukemia drugs in adults with acute myelogenous leukemia
Cardiotoxicity and myelosuppression have been reported
Indications
Indicated for the treatment of acute myelogenous leukemia (AML).
Contraindications
Hypersensitivity
Serum bilirubin >5 mg/dL [>85.5 umol/L]
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
12 mg/m2 IV; maximum cumulative lifetime idarubicin dose: 150 mg/m2 IV.
12 mg/m2 IV; maximum cumulative lifetime idarubicin dose: 150 mg/m2 IV .
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.
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.
How supplied
Idarubicin hydrochloride
injectable solution
- 1mg/mL