IDArubicin

Dosage Forms

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)

Pharmacology

Mechanism of Action

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.

Pharmacokinetics/Pharmacodynamics

Distribution

V_dss: ~1500 L/m² (Robert 1993); extensive tissue binding; CSF

Metabolism

Hepatic to idarubicinol (active metabolite)

Excretion

Primarily biliary; urine (8 to 10% as idarubicinol, ~2 to 5% as unchanged drug [Robert 1993])

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: 22 hours (range: 4 to 48 hours); >45 hours (idarubicinol)

Protein Binding

94% (idarubicinol) to 97% (idarubicin)

Use in Specific Populations

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).

Contraindications

There are no contraindications listed in the manufacturer's 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

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.

Dosage and Administration

Dosing: Adult

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.

Indication-specific dosing:

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)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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 (Dupuis 2011).

Acute myeloid leukemia (AML): Limited data available: Infants, Children, and Adolescents:

New diagnosis (CCG-2961) (Lange 2008):

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 (Dinndorf 1997; Leahey 1997).

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%.

Reconstitution

May draw up 1 mg/mL solution into a syringe (for administration) or further dilute in NS or D₅W.

Administration

Idarubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (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.

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 (Pérez 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: 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; Pérez Fidalgo 2012). 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 (Pérez Fidalgo 2012).

Storage

Store intact vials of solution refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light.

Drug Interactions

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

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. 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

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Avoid combination

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. 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. Consider therapy modification

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

Erdafitinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Fam-Trastuzumab Deruxtecan: May enhance the cardiotoxic effect 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. 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

Lasmiditan: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Avoid combination

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 and Ivacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor and Ivacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. 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

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). 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

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Avoid combination

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. Exceptions: Smallpox and Monkeypox Vaccine (Live). Avoid combination

Adverse Reactions

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.

>10%:

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)

Warnings/Precautions

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.
• Cardiomyopathy: [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 (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. Monitor cardiac function during treatment.

ASCO has developed guidelines for prevention and monitoring of cardiac dysfunction in adult survivors of cancer (ASCO [Armenian 2017]). According to the guidelines, the risk of cardiac dysfunction is increased with the following:

• High-dose anthracycline therapy (eg, doxorubicin ≥250 mg/m², epirubicin ≥600 mg/m²)
• High-dose radiotherapy (≥30 Gy) with the heart in the treatment field
• Lower-dose anthracycline (eg, doxorubicin <250 mg/m², epirubicin <600 mg/m²) in combination with lower-dose radiotherapy (<30 Gy) with the heart in the treatment field
• Lower-dose anthracycline (eg, doxorubicin <250 mg/m², epirubicin <600 mg/m²) or trastuzumab alone AND any of the following risk factors: Multiple cardiovascular risk factors (≥2 risk factors), including smoking, hypertension, diabetes, dyslipidemia, and obesity (during or after completion of therapy), or older age (≥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 (eg, doxorubicin <250 mg/m², epirubicin <600 mg/m²) followed by trastuzumab (sequential therapy)
• Other risk factors for anthracycline-induced cardiotoxicity include age ≥60 years of age at time of treatment and ≥2 cardiovascular risk factors (smoking, hypertension, diabetes, dyslipidemia, or obesity) during or after treatment.

The ASCO guidelines recommend a comprehensive assessment in patients with cancer that includes a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking. An echocardiogram should be obtained prior to initiating potentially cardiotoxic therapies. Modifiable risk factors (smoking, hypertension, diabetes, dyslipidemia, obesity) should be actively managed before initiating potentially cardiotoxic therapies. Consider cardioprotectants (eg, dexrazoxane) or continuous infusions in patients who are likely to receive high-dose anthracycline therapy. 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. Serum cardiac biomarkers are recommended, along with referral to a cardiologist if indicated.

• 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.

Disease-related concerns:

• 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.

Special populations:

• 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.
• 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 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.

Monitoring Parameters

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

Cardiovascular monitoring (ASCO [Armenian 2017]): 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. Echocardiogram (prior to treatment). 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.

Pregnancy

Pregnancy Considerations

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.

Patient Education

What is this drug used for?

• It is used to treat a type of leukemia.

Frequently reported side effects of this drug

• Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Abdominal cramps
• Headache
• Hair loss

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Heart problems like 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, swelling, pain, or irritation
• Bleeding like vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; 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
• Infection
• Burning or numbness feeling
• Severe loss of strength and energy
• Mood changes
• Mouth irritation
• Mouth sores
• Redness or irritation of the palm or soles of feet
• Signs of a significant reaction like 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. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.