Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
IDAMYCIN PFS vs ELLENCE
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 antibiotic that intercalates with DNA and inhibits topoisomerase II, resulting in DNA strand breaks and inhibition of nucleic acid synthesis.
ELLENCE (epirubicin) is an anthracycline cytotoxic antibiotic. It intercalates between DNA base pairs, inhibits topoisomerase II activity, and generates free radicals, leading to DNA damage and cell death.
Treatment of acute myeloid leukemia (AML) in adults,Treatment of acute lymphocytic leukemia (ALL) (off-label)
Adjuvant therapy in patients with axillary node-positive breast cancer,Treatment of metastatic breast cancer,Off-label: treatment of ovarian cancer, gastric cancer, small cell lung cancer, and soft tissue sarcoma
12 mg/m² intravenously over 10 to 15 minutes daily for 3 days (induction) or 12 mg/m² intravenously daily for 2 days (consolidation).
60-120 mg/m2 IV bolus or slow infusion on Day 1 every 21-28 days; or 20-30 mg/m2 IV daily for 3 days repeated every 28 days.
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.
Terminal elimination half-life is approximately 20-40 hours (mean ~30 hours). This supports a 3-week dosing interval to allow for recovery from myelosuppression.
Hepatic metabolism primarily via aldo-keto reductases to idarubicinol (active metabolite); further metabolism via glucuronidation.
Primarily hepatic metabolism via aldoketoreductases and conjugation; also metabolized by glucuronidation and cytochrome P450 (CYP) enzymes, including CYP2B4 and CYP3A4.
Renal (approximately 5-12% as unchanged drug and metabolites), biliary/fecal (significant, with 40-50% recovered in feces over 7 days).
Primarily hepatobiliary excretion: ~40-50% of dose excreted as unchanged drug and metabolites in bile and feces. Renal excretion accounts for <10% (mostly as metabolites).
Idarubicin: 94-97% bound to plasma proteins (primarily albumin); idarubicinol: 90-95% bound.
Approximately 77% bound to plasma proteins, primarily albumin.
Vd: 40-90 L/kg (extensive tissue distribution, indicating high affinity for intracellular sites such as DNA).
Mean volume of distribution is 13-34 L/kg (average ~21 L/kg), indicating extensive tissue distribution and binding.
Oral bioavailability: approximately 30% (limited clinical use; idarubicin is typically administered IV).
IV only; oral bioavailability is negligible (<5%) due to extensive first-pass metabolism. Not administered orally.
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.
No specific GFR-based dose adjustments required; caution in severe renal impairment (Cr Cl <10 m L/min) with potential increased toxicity.
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.
Child-Pugh A: reduce dose by 25%; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated or use at 50% reduction with caution.
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.
75-100 mg/m2 IV on Day 1 of 21-day cycles or 20-30 mg/m2 IV daily for 3 days every 28 days.
No specific dose adjustment, but monitor for increased myelosuppression and cardiotoxicity. Consider dose reduction based on renal function and performance status.
No specific dose adjustment; consider increased susceptibility to myelosuppression and cardiotoxicity; monitor left ventricular ejection fraction.
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.
Myocardial toxicity, including potentially fatal congestive heart failure, especially with cumulative doses >900 mg/m²; secondary acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS); extravasation leading to severe tissue necrosis; severe myelosuppression.
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
Cardiotoxicity (cumulative dose-dependent), myelosuppression, secondary leukemia, extravasation, hepatotoxicity, renal impairment, immunosuppression, tumor lysis syndrome, and fetal harm.
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)
Severe hepatic impairment (Child-Pugh class C), severe renal impairment (Cr Cl <30 m L/min), baseline neutrophil count <1500 cells/mm³, severe cardiac dysfunction, hypersensitivity to epirubicin or other anthracyclines.
Avoid grapefruit and grapefruit juice due to potential CYP3A4 inhibition affecting drug metabolism. No other significant food interactions.
Avoid grapefruit and grapefruit juice during treatment as they may affect drug metabolism. No other specific food interactions known.
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.
Pregnancy Category D. First trimester: High risk of teratogenicity including cardiac anomalies, skeletal defects, and fetal demise. Second and third trimesters: Risk of fetal growth restriction, preterm birth, and neonatal myelosuppression. Avoid use unless absolutely necessary.
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.
Contraindicated due to potential transfer into breast milk (M/P ratio not available). Theoretical risk of severe adverse effects in infants including bone marrow suppression and cardiotoxicity. Discontinue nursing or drug.
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.
No established dose adjustments; avoid use if possible. Pharmacokinetic changes include increased volume of distribution and clearance, but insufficient data to recommend dose modification. Use reduced doses if unavoidable, guided by toxicity monitoring.
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.
Ellence (epirubicin) is an anthracycline chemotherapeutic agent. It is a vesicant; extravasation can cause severe tissue necrosis. Administer via a freely flowing IV line. Premedicate with antiemetics. Monitor for cardiotoxicity, which is dose-dependent and may be cumulative. Total lifetime dose should not exceed 900-1000 mg/m². Assess cardiac function (LVEF) before and during treatment. Urine may turn red for 1-2 days after administration. Avoid live vaccines.
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.
Ellence can cause severe nausea and vomiting; take antiemetics as prescribed.,Report any pain, redness, or swelling at the injection site immediately.,Urine may appear red for 1-2 days after treatment; this is normal.,Use effective contraception during and for at least 6 months after treatment.,Avoid live vaccines (e.g., MMR, varicella) while on this medication.,Report signs of infection (fever, chills), unusual bleeding or bruising, shortness of breath, or chest pain.,Do not breastfeed while taking Ellence.
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 PFS vs ELLENCE, answered by our medical review team.
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.. ELLENCE is a Anthracycline Antineoplastic that works by ELLENCE (epirubicin) is an anthracycline cytotoxic antibiotic. It intercalates between DNA base pairs, inhibits topoisomerase II activity, and generates free radicals, leading to DNA damage and cell death.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between IDAMYCIN PFS and ELLENCE 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 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).. The standard adult dose of ELLENCE is: 60-120 mg/m2 IV bolus or slow infusion on Day 1 every 21-28 days; or 20-30 mg/m2 IV daily for 3 days repeated every 28 days.. 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 PFS and ELLENCE 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 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 . ELLENCE is classified as Category C. Pregnancy Category D. First trimester: High risk of teratogenicity including cardiac anomalies, skeletal defects, and fetal demise. Second and third trimesters: Risk of fetal growt. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.