Version July 2025
Idarubicin should be given slowly into a freely flowing intravenous infusion; it must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration.
As is the case with other anthracyclines, the use of idarubicin can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have preexisting cardiac disease.
As is usual with antileukemic agents, severe myelosuppression occurs when idarubicin is used at effective therapeutic doses.
It is recommended that idarubicin be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
Dosage should be reduced in patients with impaired hepatic function.
Dosage should be reduced in patients with impaired renal function.
Dosage guidance:
Safety: Actively manage modifiable cardiac risk factors (smoking, hypertension, diabetes, dyslipidemia, obesity) before initiating treatment (Ref). Do not use idarubicin in patients with preexisting bone marrow suppression unless the benefit outweighs the risk. Ensure adequate hydration and consider use of antihyperuricemic prophylaxis in patients at risk for tumor lysis syndrome. Control systemic infections prior to idarubicin initiation.
Clinical considerations: Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).
Acute lymphoblastic leukemia, recurrent or refractory, salvage therapy (off-label use): Induction: IV: 40 mg/m2 on day 3 (in combination with cytarabine, intrathecal methotrexate, and granulocyte-colony stimulating factor) for 1 cycle (Ref).
Acute myeloid leukemia :
Induction: IV: 12 mg/m2 on days 1 to 3 (in combination with cytarabine) for 1 cycle (Ref); a second induction cycle may be administered after 3 to 4 weeks if necessary (Ref).
Consolidation: IV: 12 mg/m2 on day 1 of cycle 1 (in combination with cytarabine) and 12 mg/m2 on days 1 and 2 of cycle 2 (in combination with cytarabine) (Ref).
Acute myeloid leukemia, poor-risk disease (off-label dosing): Induction: FLAG-IDA regimen: IV: 8 mg/m2 on days 4 to 6 (in combination with fludarabine, cytarabine, and granulocyte-colony stimulating factor) for 2 cycles (Ref).
Acute myeloid leukemia, relapsed/refractory (off-label dosing): FLAG-IDA regimen: IV: 10 mg/m2 on days 1 to 3 (in combination with fludarabine, cytarabine, and filgrastim); a second course may be given for consolidation upon hematologic recovery (Ref).
Acute promyelocytic leukemia:
LPA 2005 regimen (high-risk patients):
Induction (all patients): IV: 12 mg/m2/day on days 2, 4, 6, and 8 (day 8 dose was omitted in patients >70 years of age) in combination with ATRA (tretinoin) (Ref).
Consolidation (patients ≤60 years of age): IV: 5 mg/m2/day for 4 days in consolidation cycle 1 and 12 mg/m2/day for 1 day in consolidation cycle 3 (in combination with ATRA [tretinoin] and cytarabine) (Ref).
APML4 protocol (Iland 2012): Induction (age-adjusted dosing):
Age <60 years of age: IV: 12 mg/m2/day on days 2, 4, 6, and 8 (in combination with ATRA [tretinoin] and arsenic trioxide).
Age 61 to 70 years: IV: 9 mg/m2/day on days 2, 4, 6, and 8 (in combination with ATRA [tretinoin] and arsenic trioxide).
Age >70 years of age: IV: 6 mg/m2/day on days 2, 4, 6, and 8 (in combination with ATRA [tretinoin] and arsenic trioxide).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, it does recommend that dosage reductions be made. Patients with Scr ≥2 mg/dL did not receive treatment in many clinical trials.
The following adjustments have been recommended (Ref):
GFR ≥30 mL/minute: No dosage adjustment is necessary.
GFR <30 mL/minute: Consider administering 67% of original dose.
Hemodialysis: Consider administering 67% of original dose.
Bilirubin 2.6 to 5 mg/dL: Administer 50% of dose (Ref).
Bilirubin >5 mg/dL: Avoid use (Ref).
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).
Manufacturer labeling: If patients experience severe mucositis during the first induction cycle, delay administration of the second cycle until mucositis has resolved; consider reducing the dose by 25% for subsequent cycles. In studies, if severe myelosuppression occurred, subsequent courses were administered with a 25% dose reduction.
Cardiotoxicity: Consider dexrazoxane (if appropriate) to reduce cardiac toxicity in patients who have received a high cumulative dose of anthracycline therapy (Ref).
Asymptomatic cardiac dysfunction : Consider initiating heart failure medications (eg, an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and/or beta blockers) in patients with asymptomatic (stage B) heart disease (Ref).
Mild cardiac dysfunction: Continue treatment with close cardiovascular monitoring (Ref).
Moderate or severe cardiac dysfunction: Interrupt treatment and utilize a multidisciplinary approach when deciding if/when to restart. Initiation of heart failure medications is recommended (Ref).
Symptomatic cardiac dysfunction: Initiate heart failure medications (Ref).
Mild cardiac dysfunction: Consider a multidisciplinary approach for decisions regarding treatment interruption versus continuation (Ref).
Moderate cardiac dysfunction: Interrupt treatment; consider a multidisciplinary approach for decisions regarding treatment reinitiation (Ref).
Severe cardiac dysfunction: Discontinue anthracycline therapy (Ref).
Refer to adult dosing.
(For additional information see "Idarubicin: Pediatric drug information")
Note: Dose, frequency, number of doses, and start date may vary by protocol and/or treatment phase; refer to specific protocol. In general, idarubicin use in pediatric patients is rare and has been replaced by newer agents and protocols. Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).
Acute myeloid leukemia (AML): Limited data available: Infants, Children, and Adolescents:
New diagnosis (CCG-2961) (Ref):
Induction: IV: IdaDCTER: Idarubicin 5 mg/m2/dose daily for 4 days on days 0 to 3 in combination with cytarabine, etoposide, thioguanine, and dexamethasone.
Consolidation: IV:
IdaDCTER: Idarubicin 5 mg/m2/dose daily for 4 days on days 0 to 3 in combination with cytarabine, etoposide, thioguanine, and dexamethasone.
OR
Idarubicin 12 mg/m2/dose daily for 3 days on days 0 to 2 in combination with fludarabine and cytarabine.
Relapsed/refractory: IV: Children and Adolescents: 12 mg/m2 once daily for 3 days in combination with fludarabine and cytarabine (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no specific dosage adjustments provided in the manufacturer's labeling; however, it does recommend that dosage reductions be made. Adult patients with Scr ≥2 mg/dL did not receive treatment in many clinical trials. The following adjustments have also been recommended (Ref):
Infants, Children, and Adolescents:
GFR >50 mL/minute/1.73 m2: No adjustment necessary.
GFR ≤50 mL/minute/1.73 m2: Administer 75% of dose.
Intermittent hemodialysis: Administer 75% of dose.
Peritoneal dialysis (PD): Administer 75% of dose.
Continuous renal replacement therapy (CRRT): Administer 75% of dose.
There are no specific dosage adjustments provided in the manufacturer's labeling; however, it does recommend that dosage reductions be made. Based on experience in adult patients, avoid use if bilirubin is >5 mg/dL and dosage adjustment suggested if bilirubin is 2.6 to 5 mg/dL (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults and may include combination therapy.
>10%:
Cardiovascular: Cardiac disorder (16%)
Dermatologic: Alopecia (77%), dermatological reaction (46%, including bullous pemphigoid [palms and soles], skin rash, urticaria)
Gastrointestinal: Abdominal cramps (≤73%), diarrhea (≤73%; grade 4: <5%), nausea (≤82%; grade 4: <5%), stomatitis (50%; grade 4: <5%), vomiting (≤82%; grade 4: <5%)
Hematologic & oncologic: Hemorrhage (63%)
Infection: Infection (95%)
Nervous system: Headache (20%), mental status changes (41%)
Respiratory: Pulmonary disease (39%)
Miscellaneous: Fever (26%)
1% to 10%:
Nervous system: Cerebellar disorder (4%), peripheral neuropathy (7%), seizure (4%)
Respiratory: Pulmonary hypersensitivity reaction (2%)
Frequency not defined:
Hematologic & oncologic: Bone marrow depression
Miscellaneous: Radiation recall phenomenon
Postmarketing:
Cardiovascular: Acute myocardial infarction, cardiac arrhythmia (including atrial fibrillation), cardiomyopathy (Ahmed 2019), chest pain, decreased left ventricular ejection fraction, heart failure
Gastrointestinal: Enterocolitis (with perforation)
Local: Urticaria at injection site
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to idarubicin, any component of the formulation, or to other anthracyclines or anthracenediones; uncontrolled infections; history of severe heart disease, recent myocardial infarction, severe myocardial insufficiency, severe arrhythmia; previous therapy with maximum cumulative doses of idarubicin, doxorubicin, daunorubicin, epirubicin, or other anthracycline and anthracenediones; severe persistent drug-induced myelosuppression; severe hepatic impairment; severe renal impairment
Concerns related to adverse effects:
• Bone marrow suppression: Severe myelosuppression occurs when idarubicin is used at effective therapeutic doses. Patients are at risk of developing infection and bleeding due to neutropenia and thrombocytopenia, respectively (may be fatal).
• Cardiomyopathy: Idarubicin may cause myocardial toxicity leading to heart failure. Cardiotoxicity is more common in patients who have previously received anthracyclines or have preexisting cardiac disease. The risk of myocardial toxicity is also increased in patients with concomitant or prior mediastinal/pericardial irradiation, patients with anemia, bone marrow depression, infections, leukemic pericarditis, or myocarditis. Patients with active or dormant cardiovascular disease, concurrent administration of cardiotoxic drugs (eg, trastuzumab, cyclophosphamide, paclitaxel), prior therapy with other anthracyclines or anthracenediones are also at increased risk for cardiotoxicity. Potentially fatal heart failure, acute arrhythmias (may be life-threatening) or other cardiomyopathies may also occur. Regular monitoring of left ventricular ejection fraction (LVEF) is recommended, especially in patients with cardiac risk factors or impaired cardiac function. The half-life of other cardiotoxic agents must be considered. Avoid the use of anthracycline-based therapy for at least 5 half-lives after discontinuation of the cardiotoxic agent, and specifically avoid idarubicin for up to 7 months after discontinuation of trastuzumab.
According to ASCO guidelines (ASCO [Armenian 2017]), the risk of cardiac dysfunction is increased with high-dose anthracycline therapy (eg, equivalent to doxorubicin ≥250 mg/m2); high-dose radiotherapy (≥30 Gy) with the heart in the treatment field; lower-dose anthracyclines (eg, equivalent to doxorubicin <250 mg/m2) in combination with lower-dose radiotherapy (<30 Gy) with the heart in the treatment field; lower-dose anthracyclines AND any of the following risk factors: ≥2 cardiovascular risk factors (including smoking, hypertension, diabetes, dyslipidemia, and obesity) during or after completion of therapy or ≥60 years of age at cancer treatment, or compromised cardiac function (eg, borderline low LVEF [50% to 55%], history of MI, moderate or higher valvular heart disease) before or during treatment; treatment with lower-dose anthracycline followed by trastuzumab (sequential therapy); other risk factors for anthracycline-induced cardiotoxicity include ≥60 years of age at time of treatment and 2 or more cardiovascular risk factors (smoking, hypertension, diabetes, dyslipidemia, or obesity) during or after treatment.
• Extravasation: Vesicant; may cause severe local tissue necrosis if extravasation occurs. For IV administration only; not for IM or SUBQ administration. Administer through a freely flowing IV infusion line preferably into a large vein. Ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation.
• GI toxicity: Nausea/vomiting, mucositis, abdominal pain, and diarrhea commonly occur, although are severe in a small percentage of patients. Severe enterocolitis with perforation has been reported rarely (risk of perforation may be increased by instrumental intervention); consider the possibility of perforation in patients who develop severe abdominal pain and evaluate/manage appropriately.
• Hyperuricemia: Rapid lysis of leukemic cells may lead to hyperuricemia.
Special populations:
• Older adult: Patients >60 years of age who were undergoing induction therapy experienced heart failure, serious arrhythmias, chest pain, MI, and asymptomatic declines in LVEF more frequently than younger patients.
• Pediatrics: A panel from the American Society of Pediatric Hematology/Oncology (ASPHO) and International Society of Pediatric Oncology (SIOP) recommends in favor of an anthracycline infusion duration of at least 1 hour in pediatric patients to reduce the potential for cardiotoxicity (ASPHO/SIOP [Loeffen 2017]). However, extravasation risks should also be minimized and the protocol infusion duration specified in a protocol should be followed, particularly if the patient is receiving dexrazoxane as a cardioprotectant.
Other warnings/precautions:
• Experienced provider: Administer under the supervision of a provider experienced in leukemia and cancer chemotherapy, with capability to respond rapidly in the event of severe hemorrhagic conditions and/or overwhelming infection.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous, as hydrochloride [preservative free]:
Idamycin PFS: 5 mg/5 mL (5 mL); 10 mg/10 mL (10 mL); 20 mg/20 mL (20 mL)
Generic: 5 mg/5 mL (5 mL); 10 mg/10 mL (10 mL); 20 mg/20 mL (20 mL)
Yes
Solution (Idamycin PFS Intravenous)
5 mg/5 mL (per mL): $12.94
10 mg/10 mL (per mL): $12.93
20 mg/20 mL (per mL): $12.42
Solution (IDArubicin HCl Intravenous)
5 mg/5 mL (per mL): $7.20 - $18.54
10 mg/10 mL (per mL): $7.20 - $16.07
20 mg/20 mL (per mL): $7.20 - $13.78
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Generic: 1 mg/mL (5 mL, 10 mL, 20 mL)
Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).
IV: For IV administration only. Do not administer IM or SubQ; administer as slow injection over 10 to 15 minutes into a free-flowing IV solution of NS or D5W.
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Initiate antidote (dexrazoxane or dimethyl sulfate [DMSO]). Apply dry cold compresses for 20 minutes 4 times daily for 1 to 2 days (Ref); withhold cooling beginning 15 minutes before dexrazoxane infusion; continue withholding cooling until 15 minutes after infusion is completed. Topical DMSO should not be administered in combination with dexrazoxane; may lessen dexrazoxane efficacy.
Dexrazoxane: 1,000 mg/m2 (maximum dose: 2,000 mg) IV (administer in a large vein remote from site of extravasation) over 1 to 2 hours days 1 and 2, then 500 mg/m2 (maximum dose: 1,000 mg) IV over 1 to 2 hours day 3; begin within 6 hours of extravasation. Day 2 and day 3 doses should be administered at approximately the same time (±3 hours) as the dose on day 1 (Ref). Note: Reduce dexrazoxane dose by 50% in patients with moderate to severe renal impairment (CrCl <40 mL/minute).
DMSO: Apply topically to a region covering twice the affected area every 8 hours for 7 days; begin within 10 minutes of extravasation; do not cover with a dressing (Ref).
Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).
For IV administration only. Do not administer IM or SubQ; administer as slow push over 3 to 5 minutes, preferably into the side of a freely-running saline or dextrose infusion or as intermittent infusion over 10 to 15 minutes into a free-flowing IV solution of NS or D5W.
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Initiate antidote (dimethyl sulfate [DMSO] or dexrazoxane [adult]) (see Management of Drug Extravasations for more details). Apply dry cold compresses for 20 minutes 4 times daily for 1 to 2 days (Ref); withhold cooling beginning 15 minutes before dexrazoxane infusion; continue withholding cooling until 15 minutes after infusion is completed. Topical DMSO should not be administered in combination with dexrazoxane; may lessen dexrazoxane efficacy.
Hazardous agent (NIOSH 2024 [table 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Acute myeloid leukemia: Treatment of acute myeloid leukemia in adults (in combination with other approved chemotherapy agents).
Acute lymphoblastic leukemia, recurrent or refractory, salvage therapy
IDArubicin may be confused with DAUNOrubicin, daunorubicin/cytarabine, DOXOrubicin, epiRUBicin, idaruCIZUmab, idelalisib, valrubicin
Idamycin PFS may be confused with Adriamycin
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Substrate of CYP2C9 (Minor), CYP2D6 (Minor), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Ado-Trastuzumab Emtansine: May increase cardiotoxic effects of Anthracyclines. Management: When possible, patients treated with ado-trastuzumab emtansine should avoid anthracycline-based therapy for up to 7 months after stopping ado-trastuzumab emtansine. Monitor closely for cardiac dysfunction in patients receiving this combination. Risk D: Consider Therapy Modification
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Bevacizumab: May increase cardiotoxic effects of Anthracyclines. Risk X: Avoid
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CycloPHOSphamide: May increase cardiotoxic effects of IDArubicin. Risk X: Avoid
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Fam-Trastuzumab Deruxtecan: May increase cardiotoxic effects of Anthracyclines. Management: When possible, patients treated with fam-trastuzumab deruxtecan should avoid anthracycline-based therapy for up to 7 months after stopping fam-trastuzumab deruxtecan. Monitor closely for cardiac dysfunction in patients receiving this combination. Risk D: Consider Therapy Modification
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Margetuximab: Anthracyclines may increase adverse/toxic effects of Margetuximab. Specifically, the risk of cardiac dysfunction may be increased. Management: Avoid anthracycline-based therapy for up to 4 months after discontinuing margetuximab due to an increased risk of cardiac dysfunction. If anthracyclines must be used with margetuximab monitor cardiac function closely. Risk D: Consider Therapy Modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification
Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Taxane Derivatives: May increase adverse/toxic effects of Anthracyclines. Specifically, the risk of cardiotoxicity may be increased with this combination. Taxane Derivatives may increase serum concentration of Anthracyclines. Management: Administer doxorubicin before paclitaxel, administer idarubicin after paclitaxel has been stopped for 5 half lives, consider use of liposomal doxorubicin, epirubicin, or docetaxel instead of doxorubicin/paclitaxel. Monitor for cardiovascular toxicities. Risk D: Consider Therapy Modification
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Trastuzumab: May increase cardiotoxic effects of Anthracyclines. Management: When possible, patients treated with trastuzumab should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab. Monitor closely for cardiac dysfunction in patients receiving anthracyclines with trastuzumab. Risk D: Consider Therapy Modification
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Evaluate pregnancy status prior to use in patients who could become pregnant; pregnancy should be avoided during treatment with idarubicin.
Patients who could become pregnant should use effective contraception during therapy and for 6.5 months after the last idarubicin dose. Patients with partners who could become pregnant should also use effective contraception during therapy and for 3.5 months after the last dose of idarubicin.
Idarubicin is associated with an intermediate risk of azoospermia and infertility in males (ESMO [Lambertini 2020]). Fertility preservation should be considered for both females and males prior to treatment with idarubicin and/or seek genetic counseling after treatment. Recommendations are available for fertility preservation in adult patients treated with anticancer agents (ASCO [Oktay 2018]).
Idarubicin is more lipophilic than other anthracycline antineoplastic agents, therefore placental transfer is more likely (BSH [Ali 2015]; ELN [Döhner 2010]). Neonatal neutropenia, cardiac cardiomyopathy, and an increased risk of other fetal complications may be associated with in utero exposure to idarubicin (BSH [Ali 2015]; Chang 2015; Lishner 2016; Thomas 2015). Fetal fatality has been reported following maternal use during the second trimester.
Available guidelines recommend use of an anthracycline agent other than idarubicin (in combination with cytarabine) for induction treatment in acute myeloid leukemia (AML) in pregnant patients, and treatment should only be in the second and third trimester (BSH [Ali 2015]; ESMO [Peccatori 2013]; Lishner 2016). The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy; the guidelines recommend referral to a facility with expertise in cancer during pregnancy and a multidisciplinary team (obstetrician, neonatologist, oncology team) is encouraged (ESMO [Peccatori 2013]).
A long-term observational research study is collecting information about the diagnosis and treatment of cancer during pregnancy. For additional information about the pregnancy and cancer registry or to become a participant, contact Cooper Health (1-877-635-4499).
It is not known if idarubicin is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding should be discontinued prior to idarubicin therapy; patients should not breastfeed during therapy and for 14 days after the last idarubicin dose.
Monitor cumulative (lifetime) anthracycline/idarubicin dose. CBC with differential and platelet count (frequently), cardiac function (LVEF; prior and during treatment), serum electrolytes, renal function (serum creatinine; prior to and during treatment), uric acid, liver function (ALT, AST, bilirubin; prior to and during treatment). Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor infusion site for signs of extravasation; monitor for GI toxicity and infection.
Additional cardiovascular monitoring (ASCO [Armenian 2017], ESC [Lyon 2022]): Comprehensive assessment prior to treatment including a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking. Obtain echocardiogram (transthoracic preferred, perform at baseline and 12 months after therapy completion for all patients; in addition, perform every 2 cycles and within 3 months after therapy completion for high- or very high-risk patients). Cardiac biomarkers (troponin and natriuretic peptide at baseline for high and very high-risk patients [may consider for low- and moderate-risk]; also prior to each cycle during anthracycline treatment and at 3 and 12 months after therapy completion for high- and very high-risk patients). In patients who develop signs/symptoms of cardiac dysfunction during therapy, an echocardiogram is recommended for diagnostic workup; if echocardiogram is not available or feasible, a cardiac MRI (preferred) or MUGA scan may be utilized; obtain serum cardiac biomarkers. Refer to a cardiologist when clinically indicated. Consider cardioprotectants (eg, dexrazoxane) or continuous infusions in patients who are likely to receive high-dose anthracycline therapy.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Idarubicin inhibits DNA and RNA synthesis by intercalation between DNA base pairs and by steric obstruction. Although the exact mechanism is unclear, it appears that direct binding to DNA (intercalation) and inhibition of DNA repair (topoisomerase II inhibition) result in blockade of DNA and RNA synthesis and fragmentation of DNA.
Distribution: Vdss: 1,500 L/m2 (Robert 1993); extensive tissue binding; CSF
Protein binding: 94% (idarubicinol) to 97% (idarubicin)
Metabolism: Hepatic to idarubicinol (active metabolite)
Half-life elimination:
Children: Children ≥1 year of age and adolescents: 17.6 ± 6.8 hours (range: 8.3 to 29.6 hours) (Reid 1990)
Adults: Adults: 22 hours (range: 4 to 48 hours); >45 hours (idarubicinol)
Excretion: Primarily biliary; urine (8 to 10% as idarubicinol, ~2% to 5% as unchanged drug [Robert 1993])
Altered kidney function: The disposition may be affected in patients with renal impairment.
Hepatic function impairment: Possible impaired metabolism leading to higher systemic concentrations in patients with moderate and severe impairment; disposition may also be affected.
