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DAUNOrubicin (Conventional)

Pronunciation

(daw noe ROO bi sin con VEN sha nal)

Index Terms

  • Cerubidine
  • Conventional Daunomycin
  • Daunomycin
  • DAUNOrubicin Hydrochloride
  • Rubidomycin Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injectable, Intravenous:

Generic: 5 mg/mL (4 mL)

Injectable, Intravenous [preservative free]:

Generic: 5 mg/mL (4 mL, 10 mL)

Pharmacologic Category

  • Antineoplastic Agent, Anthracycline
  • Antineoplastic Agent, Topoisomerase II Inhibitor

Pharmacology

Inhibits DNA and RNA synthesis by intercalation between DNA base pairs and by steric obstruction. Daunomycin intercalates at points of local uncoiling of the double helix. 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

Distributes widely into tissues, particularly the liver, kidneys, lung, spleen, and heart; does not distribute into the CNS

Metabolism

Primarily hepatic to daunorubicinol (active), then to inactive aglycones, conjugated sulfates, and glucuronides

Excretion

Feces (40%); urine (~25% as unchanged drug and metabolites)

Half-Life Elimination

Initial: 45 minutes; Terminal: 18.5 hours; Daunorubicinol plasma half-life: ~27 hours

Use: Labeled Indications

Acute lymphocytic leukemia: Treatment (remission induction) of acute lymphocytic leukemia (ALL) in children and adults (in combination with other chemotherapy)

Acute myeloid leukemia: Treatment (remission induction) of acute myeloid leukemia (AML) in adults (in combination with other chemotherapy)

Contraindications

Hypersensitivity to daunorubicin or any component of the formulation

Dosing: Adult

Daunorubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Basch, 2011; Roila, 2010).

Manufacturer’s labeling: Note: Cumulative doses above 550 mg/m2 in adults without risk factors for cardiotoxicity and above 400 mg/m2 in adults receiving chest irradiation are associated with an increased risk of cardiomyopathy.

Acute lymphocytic leukemia (ALL):

IV: 45 mg/m2 on days 1, 2, and 3 (in combination with vincristine, prednisone, and asparaginase)

Acute myeloid leukemia (AML):

Adults <60 years: Induction: IV: 45 mg/m2 on days 1, 2, and 3 of the first course of induction therapy; subsequent courses: 45 mg/m2 on days 1 and 2 (in combination with cytarabine)

Adults ≥60 years: Induction: IV: 30 mg/m2 on days 1, 2, and 3 of the first course of induction therapy; subsequent courses: 30 mg/m2 on days 1 and 2 (in combination with cytarabine)

Indication-specific dosing (off-label dosing):

ALL:

CALGB 8811 regimen: IV: 45 mg/m2 (in patients <60 years) or 30 mg/m2 (in patients ≥60 years) on days 1, 2, and 3 of induction (Course I; 4 week cycle), in combination with cyclophosphamide, prednisone, vincristine, and asparaginase (Larson, 1995)

CCG 1961: Adults ≤21 years: IV: Induction: 25 mg/m2 once weekly for 4 weeks (in combination with vincristine, prednisone, and asparaginase) (Nachman, 2009)

GRAALL-2003: Adults ≤60 years: IV:

Induction: 50 mg/m2 on days 1, 2, and 3 and 30 mg/m2 on days 15 and 16 (in combination with prednisone, vincristine, asparaginase, cyclophosphamide, and G-CSF support) (Huguet, 2009)

Late intensification: 30 mg/m2 on days 1, 2, and 3 (in combination with prednisone, vincristine, asparaginase, cyclophosphamide, and G-CSF support) (Huguet, 2009)

MRC UKALLXII/ECOG E2993: Adults <60 years: IV: Induction (Phase I): 60 mg/m2 on days 1, 8, 15, and 22 (in combination with vincristine, asparaginase, and prednisone) (Rowe, 2005)

PETHEMA ALL-96: Adults ≤30 years: IV:

Induction: 30 mg/m2 on days 1, 8, 15, and 22 (in combination with vincristine, prednisone, asparaginase, and cyclophosphamide) (Ribera, 2008)

Consolidation-2/Reinduction: 30 mg/m2 on days 1, 2, 8, and 9 (in combination with vincristine, dexamethasone, asparaginase, and cyclophosphamide) (Ribera, 2008)

Protocol 8707: Adults ≤60 years: IV: Induction and Consolidation 2A cycles: 60 mg/m2 on days 1, 2, and 3 (in combination with vincristine, prednisone, and asparaginase). An additional 60 mg/m2 daunorubicin dose may be administered on day 15 of induction if bone marrow biopsy on day 14 shows residual disease (Linker, 2002).

AML: Induction:

CCG 2891: Adults <21 years: IV: 20 mg/m2/day continuous infusion on days 0 to 4 and 10 to 14 (in combination with dexamethasone, cytarabine, thioguanine, and etoposide) (Woods, 1996)

Adults <60 years: IV: 90 mg/m2 on days 1, 2, and 3 (in combination with cytarabine). If residual disease was observed on day 12 to day 14 bone marrow biopsy, 45 mg/m2 for 3 days was administered (in combination with cytarabine) (Fernandez, 2009).

Adults <60 years: IV: 60 mg/m2 on days 1, 2, and 3 (in combination with cytarabine and cladribine); may repeat if partial remission occurs (Holowiecki, 2012).

Adults ≥60 years: IV: 45 or 90 mg/m2 on days 1, 2, and 3 (in combination with cytarabine); the escalated 90 mg/m2 dose was associated with increased remission rates and overall survival in the subgroup of patients 60 to 65 years of age as compared to patients >65 years (Lowenberg, 2009)

Acute promyelocytic leukemia (APL):

Induction: Adults: IV: 50 mg/m2 on days 3, 4, 5, and 6 (in combination with ATRA and cytarabine) (Powell, 2010) or 60 mg/m2 on days 1, 2, and 3 (in combination with ATRA and cytarabine) (Ades, 2008)

Consolidation: Adults: IV: 50 mg/m2 on days 1, 2, and 3 for 2 cycles (in combination with ATRA; arsenic trioxide was administered for 2 cycles prior to daunorubicin and ATRA) (Powell, 2010) or 60 mg/m2 on days 1, 2, and 3 during cycle 1 of consolidation (in combination with cytarabine), followed by 45 mg/m2 on days 1, 2, and 3 during cycle 2 of consolidation (in combination with cytarabine) (Ades, 2008)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Daunorubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Dupuis, 2011).

Manufacturer’s labeling: Note: Cumulative doses above 300 mg/m2 in children >2 years or 10 mg/kg in children <2 years of age are associated with an increased risk of cardiomyopathy.

Acute lymphocytic leukemia (ALL):

Children <2 years or BSA <0.5 m2: Remission induction: IV: 1 mg/kg/dose on day 1 every week for up to 4 to 6 cycles (in combination with vincristine and prednisone)

Children ≥2 years and BSA ≥0.5 m2: Remission induction: IV: 25 mg/m2 on day 1 every week for up to 4 to 6 cycles (in combination with vincristine and prednisone)

Indication-specific dosing (off-label dosing):

ALL:

CCG 1961: Children ≥10 years and Adolescents: IV: Induction: 25 mg/m2 once weekly for 4 weeks (in combination with vincristine, prednisone, and asparaginase) (Nachman, 2009)

GRAALL-2003: Adolescents ≥15 years: IV:

Induction: 50 mg/m2 on days 1, 2, and 3 and 30 mg/m2 on days 15 and 16 (in combination with prednisone, vincristine, asparaginase, cyclophosphamide, and G-CSF support) (Huguet, 2009)

Late intensification: 30 mg/m2 on days 1, 2, and 3 (in combination with prednisone, vincristine, asparaginase, cyclophosphamide, and G-CSF support) (Huguet, 2009)

MRC UKALLXII/ECOG E2993: Adolescents ≥15 years: IV: Induction (Phase I): 60 mg/m2 on days 1, 8, 15, and 22 (in combination with vincristine, asparaginase, and prednisone) (Rowe, 2005)

PETHEMA ALL-96: Adolescents ≥15 years: IV:

Induction: 30 mg/m2 on days 1, 8, 15, and 22 (in combination with vincristine, prednisone, asparaginase, and cyclophosphamide) (Ribera, 2008)

Consolidation-2/Reinduction: 30 mg/m2 on days 1, 2, 8, and 9 (in combination with vincristine, dexamethasone, asparaginase, and cyclophosphamide) (Ribera, 2008)

Acute myeloid leukemia (AML): Induction:

CCG 2891:

Children <3 years: IV: 0.67 mg/kg/day continuous infusion on days 0 to 4 and 10 to 14 (in combination with dexamethasone, cytarabine, thioguanine, and etoposide) (Woods, 1996)

Children ≥3 years and Adolescents: IV: 20 mg/m2/day continuous infusion on days 0 to 4 and 10 to 14 (in combination with dexamethasone, cytarabine, thioguanine, and etoposide) (Woods, 1996)

MRC AML 10/12: Children ≤14 years: IV: 50 mg/m2 on days 1, 3, and 5 for 2 cycles (in combination with cytarabine and etoposide) (Gibson, 2005)

Dosing: Renal Impairment

The manufacturer's labeling recommends the following adjustment: Scr >3 mg/dL: Administer 50% of normal dose

The following adjustments have also been recommended (Aronoff, 2007):

Adults: No dosage adjustment necessary.

Children:

CrCl <30 mL/minute: Administer 50% of dose

Hemodialysis/continuous ambulatory peritoneal dialysis (CAPD): Administer 50% of dose

Dosing: Hepatic Impairment

The manufacturer's labeling recommends the following adjustments:

Serum bilirubin 1.2 to 3 mg/dL: Administer 75% of dose

Serum bilirubin >3 mg/dL: Administer 50% of dose

The following adjustments have also been recommended (Floyd, 2006):

Serum bilirubin 1.2 to 3 mg/dL: Administer 75% of dose

Serum bilirubin 3.1 to 5 mg/dL: Administer 50% of dose

Serum bilirubin >5 mg/dL: Avoid use

Reconstitution

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]). Dilute vials of powder for injection [Canadian product] with 4 mL SWFI for a final concentration of 5 mg/mL. May further dilute solution or reconstituted daunorubicin solution in D5W or NS for infusion.

Administration

Daunorubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Basch, 2011; Dupuis, 2011; Roila, 2010).

For IV administration only. Do not administer IM or SubQ. Administer as slow IV push over 1 to 5 minutes into the tubing of a rapidly infusing IV solution of D5W or NS or may dilute further and infuse over 15 to 30 minutes.

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: 1000 mg/m2 (maximum dose: 2000 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: 1000 mg) IV over 1-2 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).

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]).

Compatibility

Stable in D5W, LR, NS, SWFI; incompatible with dexamethasone, fluorouracil, heparin, sodium bicarbonate.

Y-site administration: Incompatible with allopurinol, aztreonam, cefepime, fludarabine, piperacillin/tazobactam.

Storage

Solution: Store intact vials at 2°C to 8°C (36°F to 46°F). Protect from light. Retain in carton until time of use. Solution prepared for infusion in D5W or NS may be stored at 20°C to 25°C (68°F to 77°F) for up to 24 hours. Discard unused portion.

Lyophilized powder [Canadian product]: Store intact vials of powder at 15°C to 30°C (59°F to 86°F). Protect from light. Retain in carton until time of use. Reconstituted daunorubicin is stable for 24 hours at room temperature or 48 hours when refrigerated at 2°C to 8°C (36°F to 46°F). Protect reconstituted solution from light.

Drug Interactions

Ado-Trastuzumab Emtansine: May enhance the cardiotoxic effect of Antineoplastic Agents (Anthracycline, Systemic). 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 Antineoplastic Agents (Anthracycline, Systemic). Monitor therapy

Cardiac Glycosides: May diminish the cardiotoxic effect of Antineoplastic Agents (Anthracycline, Systemic). Antineoplastic Agents (Anthracycline, Systemic) 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

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 Antineoplastic Agents (Anthracycline, Systemic). 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. 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

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

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

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 Antineoplastic Agents (Anthracycline, Systemic). Taxane Derivatives may increase the serum concentration of Antineoplastic Agents (Anthracycline, Systemic). Taxane Derivatives may also increase the formation of toxic anthracycline metabolites in heart tissue. Consider therapy modification

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. Avoid combination

Trastuzumab: May enhance the cardiotoxic effect of Antineoplastic Agents (Anthracycline, Systemic). 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

Adverse Reactions

Frequency not defined.

>10%:

Cardiovascular: Cardiac failure (dose-related, may be delayed for 7 to 8 years after treatment), ECG abnormality (transient, generally asymptomatic and self-limiting; includes atrial premature contractions, ST segment changes on ECG, supraventricular tachycardia, ventricular premature contractions)

Dermatologic: Alopecia (reversible)

Gastrointestinal: Nausea (mild), stomatitis, vomiting (mild)

Genitourinary: Red urine discoloration

Hematologic & oncologic: Bone marrow depression (onset: 7 days; nadir: 10 to 14 days; recovery: 21 to 28 days; primarily leukopenia; anemia, thrombocytopenia)

Miscellaneous: Radiation recall phenomenon

1% to 10%:

Dermatologic: Discoloration of sweat

Endocrine & metabolic: Hyperuricemia

Gastrointestinal: Abdominal pain, diarrhea, discoloration of saliva, gastrointestinal ulcer

Local: Post-injection flare

Ophthalmic: Discoloration of tears

<1% (Limited to important or life-threatening): Anaphylactoid reaction, cardiac arrhythmia, cardiomyopathy, hepatitis, hypersensitivity reaction (systemic; includes angioedema, dysphagia, dyspnea, pruritus, urticaria), increased serum bilirubin, increased serum transaminases, infertility, injection site reaction (includes injection site cellulitis, local thrombophlebitis, pain at injection site), leukemia (secondary), myocardial infarction, myocarditis, pericarditis, skin rash, sterility, typhlitis (neutropenic)

ALERT: U.S. Boxed Warning

Extravasation:

Daunorubicin must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration.

Experienced physician:

It is recommended that daunorubicin be administered only by physicians who are 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.

Bone marrow suppression:

Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage.

Myocardial toxicity:

Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m2 in adults, 300 mg/m2 in children older than 2 years of age, or 10 mg/kg in children younger than 2 years of age.

Hepatic impairment:

Dosage should be reduced in patients with impaired hepatic function.

Renal impairment:

Dosage should be reduced in patients with impaired renal function.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: [U.S. Boxed Warning]: May cause severe bone marrow suppression when used at therapeutic doses; may lead to infection or hemorrhage. Use with caution in patients with drug-induced bone marrow suppression (preexisting), unless the therapy benefit outweighs the toxicity risk. Monitor blood counts at baseline and frequently during therapy.

• Extravasation: [U.S. Boxed Warning]: Potent vesicant; if extravasation occurs, severe local tissue damage leading to ulceration and necrosis, and pain may occur. For IV administration only. NOT for IM or SubQ administration. Administer through a rapidly flowing IV line. Ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation.

• Gastrointestinal toxicity: Daunorubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Basch, 2011; Dupuis, 2011; Roila, 2010).

• Myocardial toxicity: [U.S. Boxed Warning]: May cause cumulative, dose-related myocardial toxicity; may lead to heart failure. May occur either during treatment or may be delayed (months to years after cessations of treatment). The incidence of irreversible myocardial toxicity increases as the total cumulative (lifetime) dosages approach 550 mg/m2 in adults, 400 mg/m2 in adults receiving chest radiation, 300 mg/m2 in children >2 years of age, or 10 mg/kg in children <2 years of age. Total cumulative dose should take into account prior treatment with other anthracyclines or anthracenediones, previous or concomitant treatment with other cardiotoxic agents or irradiation of chest. Although the risk increases with cumulative dose, irreversible cardiotoxicity may occur at any dose level. Patients with preexisting heart disease, hypertension, concurrent administration of other antineoplastic agents, prior or concurrent chest irradiation, advanced age; and infants and children are at increased risk. Monitor left ventricular (LV) function (baseline and periodic) with ECHO or MUGA scan; monitor ECG.

• Secondary malignancy: Secondary leukemias may occur when used with combination chemotherapy or radiation therapy.

• Tumor lysis syndrome: May cause tumor lysis syndrome and hyperuricemia. Urinary alkalinization and prophylaxis with an antihyperuricemic agent may be necessary. Monitor electrolytes, renal function, and hydration status.

Disease-related concerns:

• Hepatic impairment: [U.S. Boxed Warning]: Dosage reductions are recommended in patients with hepatic impairment; significant hepatic impairment may result in increased toxicities.

• Renal impairment: [U.S. Boxed Warning]: Dosage reductions are recommended in patients with renal impairment; significant renal impairment may result in increased toxicities.

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: Cardiotoxicity may occur more frequently in elderly patients. Use with caution in patients with impaired renal function and/or poor marrow reserve due to advanced age; dosage adjustment may be necessary.

• Pediatric: Infants and children are at increased risk for developing delayed cardiotoxicity; long-term periodic cardiac function monitoring is recommended.

• Radiation recipients: Use with caution in patients who have received radiation therapy; reduce dosage in patients who are receiving radiation therapy simultaneously.

Dosage form specific issues:

• Formulations (conventional vs liposomal): Use caution when selecting product for preparation and dispensing; indications, dosages, and adverse event profiles differ between conventional daunorubicin hydrochloride solution and daunorubicin liposomal.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]).

Other warnings/precautions:

• Experienced physician: [U.S. Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician.

Monitoring Parameters

CBC with differential and platelet count, liver function test, ECG, left ventricular ejection function (echocardiography [ECHO] or multigated radionuclide angiography [MUGA] scan), renal function test, signs/symptoms of extravasation

Pregnancy Risk Factor

D

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Daunorubicin crosses the placenta. Women of reproductive potential should avoid pregnancy.

Patient Education

• 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 urine discoloration, mouth irritation, lip irritation, or alopecia. 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 5 pounds in 24 hours, dizziness, or passing out), signs of infection, angina, passing out, severe abdominal pain, severe nausea, vomiting, excessive weight loss, severe diarrhea, bruising, bleeding, loss of strength and energy, bone pain, night sweats, or severe pain or irritation at the injection site (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.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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