Idarubicin - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Idarubicin. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS • Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received prior anthracyclines or who have pre-existing cardiac disease. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment [see Warnings and Precautions ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including IDAMYCIN PFS [see Warnings and Precautions ] . • Extravasation and Tissue Necrosis: Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately terminate the infusion of IDAMYCIN PFS and institute the recommended management procedures [see Dosage and Administration and Warnings and Precautions ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage leading to congestive heart failure can occur with IDAMYCIN PFS. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment. • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS)
5 WARNINGS AND PRECAUTIONS • Myelosuppression : Severe myelosuppression resulting in severe infection, septic shock, hemorrhage, or death may occur.
Obtain complete blood counts prior to each treatment and closely monitor patients during treatment for possible clinical complications due to myelosuppression. • Tumor Lysis Syndrome : During treatment, monitor blood chemistries and manage promptly.
Treat as clinically indicated. • Hypersensitivity : Monitor patients for hypersensitivity reactions and manage as clinically indicated. • Renal Impairment : Assess renal function prior to and during treatment.
Reduce the dose in patients on dialysis or those with GFR <30 mL/min. ( 2.3 , 5.7 , 8.6 ) • Hepatic Impairment : Obtain liver tests prior to and during therapy.
Reduce dose in patients with serum bilirubin levels of 2.6 to 5 mg/dL.
Avoid use in patients with serum bilirubin greater than 5 mg/dL. ( 2.4 , 5.8 , 8.7 ) • Embryo-Fetal Toxicity : Can cause fetal harm.
Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.9 , 8.1 , 8.3 ) 5.1 Cardiomyopathy IDAMYCIN PFS can cause myocardial damage, including left ventricular failure, or congestive heart failure (CHF).
In pediatric patients, anthracycline-induced cardiomyopathy included impaired left ventricular systolic performance, reduced contractility, congestive heart failure, or death.
Cardiomyopathy may develop during treatment with IDAMYCIN PFS or up to several years after completion of treatment.
Cases of pericarditis and myocarditis have also been reported at a lower incidence and may not be dose related.
The risk of cardiomyopathy is generally proportional to the cumulative exposure to anthracycline drugs.
Include prior doses of other anthracyclines or anthracenediones in calculations of total cumulative dosage for idarubicin hydrochloride.
In adult patients, at cumulative doses exceeding 90 mg/m 2 of idarubicin hydrochloride, there is an increased incidence of drug-induced congestive heart failure.
The tolerable limit may be lower in patients who received radiation therapy to the mediastinum.
Concomitant use of cardiotoxic drugs may increase the risk of idarubicin-induced cardiac toxicity or may result in cardiotoxicity at a lower cumulative anthracycline dose.
Calculate the lifetime cumulative anthracycline exposure prior to each cycle of IDAMYCIN PFS.
IDAMYCIN PFS use is not recommended in patients whose lifetime anthracycline exposure has reached the maximum cumulative limit.
Assess left ventricular cardiac function (e.g., MUGA or echocardiogram) prior to initiation of IDAMYCIN PFS.
Perform serial cardiac monitoring, which may include electrocardiograms and/or determination of systolic ejection fraction, in all patients during treatment to detect acute changes and after treatment to detect delayed cardiotoxicity.
Increase the frequency of assessments as the cumulative anthracycline dose increases or in patients with risk factors for cardiac toxicity.
Consider long-term periodic evaluation of cardiac function in these patients.
Adults 65 years of age and older, or with pre-existing cardiac disease, may have an increased risk of anthracycline-induced cardiac toxicity, or may experience cardiotoxicity at a lower cumulative anthracycline dose.
Discontinue IDAMYCIN PFS in patients who develop signs or symptoms of cardiomyopathy.
5.2 Secondary Malignancies The risk of developing secondary AML and myelodysplastic syndrome (MDS) is increased following treatment with IDAMYCIN PFS.
AML and MDS have occurred in patients treated with anthracycline topoisomerase inhibitors when used in combination with other antineoplastic agents or radiation therapy.
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