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- Idarubicin Hydrochloride
- IMI 30
- SC 33428
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)
Brand Names: U.S.
- Idamycin PFS
- Antineoplastic Agent, Anthracycline
- Antineoplastic Agent, Topoisomerase II Inhibitor
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.
Vdss: ~1500 L/m2 (Robert 1993); extensive tissue binding; CSF
Hepatic to idarubicinol (active metabolite)
Primarily biliary; urine (8 to 10% as idarubicinol, ~2 to 5% as unchanged drug [Robert 1993])
Children: Children ≥1 year of age and adolescents: 17.6 ± 6.8 hours (range: 8.3 to 29.6 hours) (Reid 1990)
Adults: 22 hours (range: 4 to 48 hours); >45 hours (idarubicinol)
94% (idarubicinol) to 97% (idarubicin)
Special Populations: Renal Function Impairment
The disposition may be affected in patients with renal impairment.
Special Populations: Hepatic Function Impairment
Possible impaired metabolism leading to higher systemic concentrations in patients with moderate and severe impairment; disposition may also be affected.
Use: Labeled Indications
Acute myeloid leukemia: Treatment of acute myeloid leukemia (AML) in adults (in combination with other approved chemotherapy agents).
Off Label Uses
Acute myeloid leukemia (pediatric), newly diagnosed
Data from a large phase III trial support the use of idarubicin (as part of a multiagent chemotherapy regimen) in the management of newly diagnosed pediatric acute myeloid leukemia (AML) [Lange 2008].
Acute myeloid leukemia (pediatric), relapsed/refractory
Data from two small phase I/II trials suggest that idarubicin (in combination with fludarabine, cytarabine, and filgrastim) may be beneficial in pediatric patients with relapsed/refractory AML [Dinndorf 1997], [Leahey 1997]. Additional data may be necessary to further define the role of idarubicin in this condition.
There are no contraindications listed in the manufacturer's labeling.
Documentation of allergenic cross-reactivity for drugs in this class is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Hesketh 2017; Roila 2016).
Acute myeloid leukemia (AML): IV:
Manufacturer labeling: Induction: 12 mg/m2/day for 3 days (in combination with cytarabine); a second induction cycle may be administered if necessary.
AML, relapsed/refractory: FLAG-IDA regimen: 10 mg/m2/day for 3 days (in combination with fludarabine, cytarabine, and filgrastim); a second course was given for consolidation upon hematologic recovery (Parker 1997)
Acute promyelocytic leukemia (APL):
LPA 2005 (high-risk patients):
Induction (all patients): 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) (Sanz 2010)
Consolidation (patients ≤60 years of age): 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) (Sanz 2010)
APML4 protocol (Iland 2012): Induction (age-adjusted dosing):
Age <60 years of age: 12 mg/m2/day on days 2, 4, 6, and 8 (in combination with ATRA [tretinoin] and arsenic trioxide)
Age 61 to 70 years: 9 mg/m2/day on days 2, 4, 6, and 8 (in combination with ATRA [tretinoin] and arsenic trioxide)
Age >70 years of age: 6 mg/m2/day on days 2, 4, 6, and 8 (in combination with ATRA [tretinoin] and arsenic trioxide)
Refer to adult dosing.
Note: Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Dupuis 2011).
Acute myeloid leukemia (AML) (off-label use): IV:
Newly diagnosed (CCG-2961) (Lange 2008):
Induction: IdaDCTER: Idarubicin 5 mg/m2/dose daily for 4 days on days 0 to 3 in combination with cytarabine, etoposide, thioguanine, and dexamethasone
IdaDCTER: Idarubicin 5 mg/m2/dose daily for 4 days on days 0 to 3 in combination with cytarabine, etoposide, thioguanine, and dexamethasone
Idarubicin 12 mg/m2/dose daily for 3 days on days 0 to 2 in combination with fludarabine and cytarabine
Relapsed/refractory: 12 mg/m2 once daily for 3 days on days 0 to 2 in combination with fludarabine and cytarabine (Dinndorf 1997; Leahey 1997)
Dosing: Renal Impairment
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 (Aronoff 2007):
CrCl >50 mL/minute: No dosage adjustment is necessary.
CrCl 10 to 50 mL/minute: Administer 75% of dose.
CrCl <10 mL/minute: Administer 50% of dose.
Hemodialysis: Supplemental dose not needed.
Continuous ambulatory peritoneal dialysis (CAPD): Supplemental dose not needed.
Infants, Children, and Adolescents:
GFR >50 mL/minute/1.73 m2: No dosage adjustment is 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
Dosing: Hepatic Impairment
Bilirubin 2.6 to 5 mg/dL: Administer 50% of dose (Perry 2012)
Bilirubin >5 mg/dL: Avoid use
Dosing: Adjustment for Toxicity
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%.
May draw up 1 mg/mL solution into a syringe (for administration) or further dilute in NS or D5W.
Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Dupuis 2011; Hesketh 2017; Roila 2016).
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. In some pediatric protocols (off-label use), idarubicin was infused over 15 minutes or over at least 30 minutes (Lange 2008; Leahy 1997); refer to individual protocols for infusion rate details.
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 (Perez Fidalgo 2012); 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: Adults: 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 (Mouridsen 2007; Perez Fidalgo 2012). Note: Reduce dexrazoxane dose by 50% in patients with moderate to severe renal impairment (CrCl <40 mL/minute).
DMSO: Children and Adults: 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 (Perez Fidalgo 2012).
Store intact vials of solution refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light.
Ado-Trastuzumab Emtansine: May enhance the cardiotoxic effect 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. Consider therapy modification
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Bevacizumab: May enhance the cardiotoxic effect of Anthracyclines. Avoid combination
Cardiac Glycosides: May diminish the cardiotoxic effect of Anthracyclines. Anthracyclines may decrease the serum concentration of Cardiac Glycosides. The effects of liposomal formulations may be unique from those of the free drug, as liposomal formulation have unique drug disposition and toxicity profiles, and liposomes themselves may alter digoxin absorption/distribution. Monitor therapy
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Monitor therapy
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
Cyclophosphamide: May enhance the cardiotoxic effect of Anthracyclines. Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification
Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect 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. Consider therapy modification
Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
Palifermin: May enhance the adverse/toxic effect 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. Consider therapy modification
P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy
P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy
Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Taxane Derivatives: May enhance the adverse/toxic effect of Anthracyclines. Taxane Derivatives may increase the serum concentration of Anthracyclines. Taxane Derivatives may also increase the formation of toxic anthracycline metabolites in heart tissue. Consider therapy modification
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification
Trastuzumab: May enhance the cardiotoxic effect 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. Consider therapy modification
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination
The relative cardiotoxicity of idarubicin compared to doxorubicin is unclear. Some investigators report no increase in cardiac toxicity for adults at cumulative oral idarubicin doses up to 540 mg/m2; other reports suggest a maximum cumulative intravenous dose of 150 mg/m2.
Cardiovascular: Cardiac failure (dose-related), ECG abnormalities (transient; includes atrial premature contractions, S-T wave changes, supraventricular tachycardia, ventricular premature contractions; generally asymptomatic and self-limiting)
Central nervous system: Headache
Dermatologic: Alopecia (25% to 30%), skin rash (11%), urticaria
Gastrointestinal: Vomiting (30% to 60%), gastrointestinal hemorrhage (30%), diarrhea (9% to 22%), stomatitis (11%), nausea
Genitourinary: Urine discoloration (darker yellow)
Hematologic & oncologic: Anemia (effects are generally less severe with oral dosing), bone marrow suppression (nadir: 10 to 15 days; recovery: 21 to 28 days; primarily leukopenia; effects are generally less severe with oral dosing), thrombocytopenia (effects are generally less severe with oral dosing)
Hepatic: Increased serum bilirubin (≤44%), increased serum transaminases (≤44%)
Miscellaneous: Radiation recall phenomenon
1% to 10%:
Central nervous system: Peripheral neuropathy, seizure
<1%, postmarketing, and/or case reports: Cardiomyopathy, hyperuricemia, myocarditis, typhlitis (neutropenic)
Concerns related to adverse effects:
• Bone marrow suppression: [US Boxed Warning]: 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). Monitor blood counts frequently. Do not use in patients with preexisting bone marrow suppression unless the benefit outweighs the risk.
• Extravasation: [US Boxed Warning] 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. Ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation.
• Gastrointestinal toxicity: Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Dupuis 2011; Hesketh 2017; Roila 2016). Abdominal pain, diarrhea, and mucositis may commonly occur. Severe enterocolitis with perforation has been reported (rare).
• Hyperuricemia: Rapid lysis of leukemic cells may lead to hyperuricemia. Ensure adequate hydration and consider use of antihyperuricemic prophylaxis.
• Myocardial toxicity: [US Boxed Warning]: 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, prior therapy with other anthracyclines or anthracenediones are also at increased risk for cardiotoxicity. Other risk factors for anthracycline-induced cardiotoxicity include ≥60 years of age at time of treatment and ≥2 cardiovascular risk factors (smoking, hypertension, diabetes, dyslipidemia, or obesity) during or after treatment (Armenian 2017). Potentially fatal heart failure, acute arrhythmias (may be life-threatening) or other cardiomyopathies may also occur. Regular monitoring of 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. Monitor cardiac function during treatment.
• Hepatic impairment: [US Boxed Warning]: Dosage reductions are recommended in patients with hepatic impairment. Idarubicin use is not recommended if bilirubin >5 mg/dL.
• Infections: Systemic infections should be controlled prior to initiation of treatment.
• Renal impairment: [US Boxed Warning]: Dosage reductions are recommended in patients with renal impairment.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Elderly: 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.
• Experienced physician: [US Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician. Use 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.
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); monitor infusion site for signs of extravasation; monitor for gastrointestinal toxicity and infection
Adverse events were observed in animal reproduction studies. Fetal fatality was noted in a case report following second trimester exposure in a pregnant woman.
Guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy from the European Society for Medical Oncology (ESMO) suggest utilizing an anthracycline agent other than idarubicin (in combination with cytarabine) for induction treatment in acute myeloid leukemia (AML) and only in the second and third trimester; the guidelines also recommend referral to a facility with expertise in cancer during pregnancy and a multidisciplinary team (obstetrician, neonatologist, oncology team) is encouraged (Peccatori 2013).
The manufacturer recommends that women of reproductive potential avoid pregnancy during treatment.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea, vomiting, abdominal pain, diarrhea, abdominal cramps, headache, or hair loss. Have patient report immediately to prescriber signs of heart problems (cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out), severe injection site redness, burning, edema, pain, or irritation, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of infection, burning or numbness feeling, severe loss of strength and energy, mood changes, mouth irritation, mouth sores, or redness or irritation of the palm or soles of feet (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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