Idarubicin

Class
Topoisomerase inhibitors
Subclass
Anthracyclines
Substance name
IDArubicin hydrochloride
Brand names
Idamycin PFS®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment of acute myeloid leukemiaNewly-diagnosed CD33-positive
12 mg/m² IV q24h
Alternative
12 mg/m² IV q24h for 3 days
Other off-label uses
Treatment of acute lymphoblastic leukemia (maintenance therapy)
Treatment of non-Hodgkin's lymphoma (relapsed or refractory)
Indications for use
Labeled indications
Adults
Treatment of acute myeloid leukemia (newly-diagnosed CD33-positive)
Off-label indications
Adults
Treatment of acute lymphoblastic leukemia (maintenance therapy)
Treatment of non-Hodgkin's lymphoma (relapsed or refractory)
Safety risks
Boxed warnings
Congestive HF
Use extreme caution with pre-existing cardiac disease including HF, angina, LV dysfunction, recent or acute myocardial infarction, or cardiac arrhythmias.
Contraindications
Known idarubicin or other anthracycline hypersensitivity or anthracenedione hypersensitivity
Platelet counts < 50,000/mm3 (Intramuscular injections)
Warnings and precautions
Bleeding
Use caution with dental disease.
Chemotherapy-induced bone marrow suppression
Use caution with a history of bone marrow suppression, or coagulopathy, or those who have received previous myelosuppressive therapy such as chemotherapy or radiotherapy.
Tumor lysis syndrome
Use caution with large chemosensitive tumors.
Specific populations
Renal impairment
eGFR 20-50 mL/min/1.73 m²
Reduce dose by 25%.
eGFR 10-20 mL/min/1.73 m²
Use with caution. Reduce dose by 25%.
eGFR < 10 mL/min/1.73 m²
Do not use. Reduce dose by 50%.
Renal replacement therapy
Continuous renal replacement
Dose as in eGFR 10-20 mL/min/1.73 m². Reduce dose by 25%.
Intermittent hemodialysis
Do not use. Dose as in eGFR < 10 mL/min/1.73 m². Reduce dose by 50%.
Peritoneal dialysis
Do not use. Dose as in eGFR < 10 mL/min/1.73 m². Reduce dose by 50%.
Hepatic impairment
Any severity
Reduce dose. Monitor serum aminotransferases. Monitor for toxicity. - Administration not recommended in patients with serum bilirubin concentration >5 mg/dL.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
Avoid use. This drug can harm a developing fetus.
Women of childbearing potential should be advised not to become pregnant during treatment and to use adequate contraception during therapy.
This drug can induce chromosomal damage in human spermatozoa; therefore, males undergoing therapy should use effective contraceptive methods for up to 3 months after completing treatment.
Women of childbearing potential should be informed of the potential hazard to the fetus.
Women attempting to have children after completion of therapy should be advised to obtain genetic counseling first, if appropriate.
All trimesters • Australia Category: D
Avoid use.
Breastfeeding
Little information available on breastfeeding safety.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
AF, alopecia, myocardial infarction, abdominal pain, bleeding, chest pain, diarrhea, fever, headache, skin rash, urticaria
Common 1-10%
Anemia, ↓ WBC count, ↓ blood neutrophil count, ↓ platelet count, ↑ liver enzymes, oral ulcers, pancytopenia, peripheral neuropathy, nausea, seizure, vomiting
Unknown frequency
AT, AV block, bradycardia, cardiomyopathy, enterocolitis, gastrointestinal perforation, heart failure, premature ventricular contractions, ↑QTc interval, radiation recall reaction, injection site reactions, ST-segment changes, VT
Interactions
Drug(s)
Check Interactions
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