Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
IDAMYCIN vs IDAMYCIN PFS
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Idarubicin is an anthracycline antineoplastic agent that intercalates with DNA and inhibits topoisomerase II, leading to inhibition of DNA replication and transcription, and ultimately cell death. It also generates free radicals and induces apoptosis.
Idarubicin is an anthracycline antineoplastic antibiotic that intercalates with DNA and inhibits topoisomerase II, resulting in DNA strand breaks and inhibition of nucleic acid synthesis.
Treatment of acute myeloid leukemia (AML) in adults, including induction therapy in combination with other agents,Treatment of acute lymphoblastic leukemia (ALL) (off-label)
Treatment of acute myeloid leukemia (AML) in adults,Treatment of acute lymphocytic leukemia (ALL) (off-label)
12 mg/m² IV daily for 3 days (acute myeloid leukemia) or 12 mg/m² IV daily for 3 days (acute lymphoblastic leukemia); maximum cumulative dose 600 mg/m².
12 mg/m² intravenously over 10 to 15 minutes daily for 3 days (induction) or 12 mg/m² intravenously daily for 2 days (consolidation).
Terminal elimination half-life: 20-30 hours (mean ~22 hours). Prolonged in severe hepatic impairment (up to 40 hours) and may be extended in patients with renal impairment due to accumulation of active metabolite idarubicinol (half-life > 60 hours).
Terminal elimination half-life of idarubicin is 20-30 hours; idarubicinol (active metabolite) has a terminal half-life of 45-60 hours, extending myelosuppression duration.
Idarubicin is extensively metabolized in the liver to its active metabolite idarubicinol, which has similar antineoplastic activity. The primary enzyme involved is aldo-keto reductase. Idarubicin and idarubicinol are eliminated via biliary excretion and renal excretion.
Hepatic metabolism primarily via aldo-keto reductases to idarubicinol (active metabolite); further metabolism via glucuronidation.
Primarily hepatic metabolism; biliary excretion of metabolites accounts for ~50% of total elimination. Renal excretion of unchanged drug is minimal (<10%). Approximately 30-40% of the dose is recovered in urine as metabolites. Fecal elimination of metabolites accounts for ~50%.
Renal (approximately 5-12% as unchanged drug and metabolites), biliary/fecal (significant, with 40-50% recovered in feces over 7 days).
Parent drug: 94-97% bound, primarily to albumin. Idarubicinol (active metabolite): ~95% bound to albumin.
Idarubicin: 94-97% bound to plasma proteins (primarily albumin); idarubicinol: 90-95% bound.
Vd: 20-30 L/kg (mean ~25 L/kg). Very large distribution indicates extensive tissue binding and penetration into cells, particularly in bone marrow.
Vd: 40-90 L/kg (extensive tissue distribution, indicating high affinity for intracellular sites such as DNA).
Oral bioavailability: approximately 28% (range 10-40%) due to first-pass metabolism. Not available orally in typical clinical practice; IV administration is standard. Oral formulations exist for investigational use but not FDA-approved.
Oral bioavailability: approximately 30% (limited clinical use; idarubicin is typically administered IV).
If serum creatinine > 2 mg/d L or creatinine clearance < 30 m L/min, reduce dose by 25-50% and monitor cardiac function.
GFR 20-50 m L/min: Administer 75% of dose; GFR <20 m L/min: Administer 50% of dose. Not dialyzable; no supplemental dose needed post-dialysis.
Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 25%; Child-Pugh C: reduce dose by 50% or consider alternative therapy.
Child-Pugh Class B: Reduce dose by 25%; Child-Pugh Class C: Reduce dose by 50%. Severe hepatic dysfunction (bilirubin >3 mg/d L): Contraindicated unless benefit outweighs risk.
10-12 mg/m² IV daily for 3 days; maximum cumulative dose 600 mg/m²; adjust for renal/hepatic impairment.
Children: 12 mg/m² intravenously daily for 3 days (induction) or 12 mg/m² daily for 2 days (consolidation). For infants <0.5 m²: 0.75 mg/kg intravenously daily for 3 days.
Start at lower end of dosing range (e.g., 10-12 mg/m²), monitor cardiac function closely due to increased risk of cardiomyopathy; reduce dose for renal impairment.
No specific dose adjustment, but monitor for increased myelosuppression and cardiotoxicity. Consider dose reduction based on renal function and performance status.
Idarubicin should be administered only under the supervision of physicians experienced in leukemia chemotherapy. Severe myelosuppression occurs. Cardiotoxicity (including heart failure, arrhythmias, and cardiomyopathy) may occur, especially with cumulative doses exceeding 150 mg/m². Extravasation can cause severe tissue necrosis. Reduction of left ventricular ejection fraction (LVEF) and congestive heart failure have been reported.
Severe myelosuppression when used at therapeutic doses; cardiac toxicity including potentially fatal congestive heart failure, acute left ventricular failure, and arrhythmias; secondary malignancies including acute myeloid leukemia and myelodysplastic syndrome; extravasation leading to severe tissue necrosis; reduce dose in patients with hepatic impairment.
Myelosuppression: severe bone marrow suppression leading to infection, bleeding, and anemia,Cardiotoxicity: acute (arrhythmias, myocardial depression) and chronic (cumulative dose-related cardiomyopathy); monitor LVEF,Secondary malignancies: higher risk of therapy-related myelodysplasia or acute leukemia,Extravasation: severe tissue damage if extravasation occurs; use central line administration,Tumor lysis syndrome: rapid lysis of tumor cells can cause uric acid nephropathy,Hepatic impairment: requires dose reduction,Renal impairment: requires dose reduction,Immunosuppression: live vaccines contraindicated
Monitor cardiac function before and during therapy; cumulative dose increases risk of cardiotoxicity,Severe myelosuppression with risk of infection and bleeding,Extravasation risk: administer via secure IV line,Secondary malignancies reported,Hepatic and renal impairment may require dose adjustment,Tumor lysis syndrome,May impair fertility
Hypersensitivity to idarubicin or any component of the formulation,Severe hepatic impairment (bilirubin >5 mg/d L),Severe renal impairment (creatinine clearance <15 m L/min),Inadequate bone marrow reserve due to prior chemotherapy or radiotherapy,Pregnancy (category D): can cause fetal harm,Lactation: discontinue nursing or drug
Hypersensitivity to idarubicin or other anthracyclines,Severe hepatic impairment (Child-Pugh class C),Severe renal impairment (creatinine clearance < 30 m L/min),Pre-existing severe myelosuppression not due to leukemia,Severe cardiac dysfunction (e.g., recent myocardial infarction, cardiomyopathy)
Avoid grapefruit and grapefruit juice as they may inhibit CYP3A4 metabolism and increase idarubicin toxicity. No other significant food interactions are reported. Maintain adequate hydration to prevent tumor lysis syndrome; avoid alcohol as it may exacerbate hepatic toxicity.
Avoid grapefruit and grapefruit juice due to potential CYP3A4 inhibition affecting drug metabolism. No other significant food interactions.
Pregnancy category D. First trimester: high risk of fetal malformations (central nervous system, cardiovascular, skeletal). Second and third trimesters: increased risk of fetal growth restriction, preterm birth, and neonatal myelosuppression. Avoid use unless maternal benefit outweighs risks.
Idarubicin is embryotoxic and teratogenic in animal studies. Human data are limited, but it is classified as FDA Pregnancy Category D. There is evidence of fetal risk in the first trimester, including malformations and spontaneous abortion. In the second and third trimesters, there is risk of fetal growth restriction, preterm labor, and neonatal myelosuppression. Use only if potential benefit justifies risk.
Not recommended. Idarubicin is excreted into breast milk; M/P ratio not available. Potential for severe adverse effects in nursing infant including neutropenia and cardiotoxicity.
It is unknown if idarubicin is excreted in human breast milk. Due to potential for serious adverse reactions in nursing infants, including immunosuppression and carcinogenesis, breastfeeding is contraindicated during treatment and for at least 1 month after the last dose. M/P ratio is not established.
No established dose adjustments in pregnancy. Pharmacokinetic changes (increased volume of distribution, altered clearance) may require dose individualization based on BSA and toxicity monitoring. Use lowest effective dose with aggressive supportive care.
No specific dose adjustments have been established for pregnancy. Physiological changes in pregnancy (increased plasma volume, altered hepatic metabolism) may affect pharmacokinetics but no formal studies exist. Use standard dosing based on body surface area with caution and monitor for toxicity.
Idarubicin is a potent anthracycline with significant cardiotoxicity; cumulative lifetime dose should not exceed 150 mg/m² in adults. Administer IV slowly over 5-10 minutes to reduce risk of extravasation, which causes severe tissue necrosis. Monitor for acute infusion reactions and premedicate with antiemetics. Renal and hepatic impairment require dose adjustment; check bilirubin and creatinine levels before each cycle. Concomitant use with other cardiotoxic agents increases risk of heart failure.
Administer IV only; extravasation causes severe tissue necrosis. Premedicate with antiemetics. Monitor for cardiotoxicity with cumulative doses >550 mg/m2 (or 450 mg/m2 with prior chest irradiation). Urine may turn reddish for 1-2 days. Leukocyte nadir occurs 10-14 days after administration.
Tell your doctor if you have heart, liver, or kidney problems before starting treatment.,You will need regular blood tests to monitor blood counts and heart function.,Report any chest pain, shortness of breath, or swelling in your ankles immediately.,Avoid grapefruit and grapefruit juice during treatment as it may increase side effects.,Use effective contraception during and for at least 6 months after treatment.,Notify your healthcare provider if you experience fever, chills, or signs of infection.,This medication may cause your urine to turn reddish-orange for 1-2 days after administration.
This drug can cause severe nausea and vomiting; take antiemetics as prescribed.,Your urine may appear red or orange for 1-2 days after treatment; this is normal.,Report any pain, redness, or swelling at the injection site immediately.,Avoid receiving live vaccines during treatment and for 6 months after.,Use effective contraception during and for at least 6 months after therapy.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about IDAMYCIN vs IDAMYCIN PFS, answered by our medical review team.
IDAMYCIN is a Anthracycline Antineoplastic that works by Idarubicin is an anthracycline antineoplastic agent that intercalates with DNA and inhibits topoisomerase II, leading to inhibition of DNA replication and transcription, and ultimately cell death. It also generates free radicals and induces apoptosis.. IDAMYCIN PFS is a Anthracycline Antineoplastic that works by Idarubicin is an anthracycline antineoplastic antibiotic that intercalates with DNA and inhibits topoisomerase II, resulting in DNA strand breaks and inhibition of nucleic acid synthesis.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between IDAMYCIN and IDAMYCIN PFS depend on the specific clinical indication. These are both Anthracycline Antineoplastic agents and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of IDAMYCIN is: 12 mg/m² IV daily for 3 days (acute myeloid leukemia) or 12 mg/m² IV daily for 3 days (acute lymphoblastic leukemia); maximum cumulative dose 600 mg/m².. The standard adult dose of IDAMYCIN PFS is: 12 mg/m² intravenously over 10 to 15 minutes daily for 3 days (induction) or 12 mg/m² intravenously daily for 2 days (consolidation).. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between IDAMYCIN and IDAMYCIN PFS in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. IDAMYCIN is classified as Category C. Pregnancy category D. First trimester: high risk of fetal malformations (central nervous system, cardiovascular, skeletal). Second and third trimesters: increased risk of fetal gro. IDAMYCIN PFS is classified as Category C. Idarubicin is embryotoxic and teratogenic in animal studies. Human data are limited, but it is classified as FDA Pregnancy Category D. There is evidence of fetal risk in the first . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.