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Daunorubicin: Pediatric drug information

Daunorubicin: Pediatric drug information
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For additional information see "Daunorubicin: Drug information" and "Daunorubicin: Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US 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.

Cardiomyopathy:

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.

Brand Names: Canada
  • Cerubidine
Therapeutic Category
  • Antineoplastic Agent, Anthracycline;
  • Antineoplastic Agent, Antibiotic;
  • Antineoplastic Agent, Topoisomerase II Inhibitor
Dosing: Pediatric

Note: Dose, frequency, number of doses, and start date may vary by protocol and treatment phase; refer to individual protocols. In pediatric patients, dosing may be based on either BSA (mg/m2) or weight (mg/kg); use extra caution to verify dosing parameters during calculations.

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

Monitor cumulative anthracycline dose (combined); the risk for cardiomyopathy increases as the cumulative anthracycline dose increases (>250 mg/m2 of doxorubicin isotoxic equivalent dose in pediatric patients <18 years and 550 mg/m2 of doxorubicin isotoxic equivalent dose in patients ≥18 years); also dependent on other/additional risk factors (eg, chest irradiation); interpatient variability exists (eg, some patients may experience left ventricular dysfunction at lower doses). To calculate doxorubicin equivalent dose of daunorubicin, multiply total daunorubicin dose by 0.5 (Ref).

Acute lymphocytic leukemia, B cell

Acute lymphocytic leukemia, B cell (B-ALL):

AALL0232 (Ref): High risk, newly diagnosed:

Children and Adolescents:

Induction: IV: 25 mg/m2/dose once weekly for 4 weeks (in combination with intrathecal cytarabine, vincristine, prednisone/dexamethasone [age-dependent], pegaspargase, and intrathecal methotrexate).

Extended induction: IV: 25 mg/m2/dose once on day 1 (in combination with vincristine, prednisone/dexamethasone [age-dependent], and pegaspargase).

Memorial Sloan Kettering-New York IIB Protocol (Ref): High risk, newly diagnosed:

Children and Adolescents:

Induction: IV: 60 mg/m2/day as a continuous infusion over 24 hours on days 0 and 1 for a total dose of 120 mg/m2 (in combination with cyclophosphamide, vincristine, prednisone, pegaspargase, and intrathecal methotrexate).

Maintenance I: IV: 20 mg/m2/day as a continuous infusion over 24 hours on days 40 and 41 for a total dose of 40 mg/m2 (in combination with prednisone, mercaptopurine, cyclophosphamide, methotrexate, vincristine, cytarabine, thioguanine, and intrathecal methotrexate). Repeat for a total of 5 cycles.

GRAALL-2003 (Ref):

Adolescents ≥15 years:

Induction: IV: 50 mg/m2/dose 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).

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

MRC UKALLXII/ECOG E2993 (Ref):

Adolescents ≥15 years: Induction (Phase I): IV: 60 mg/m2/dose on days 1, 8, 15, and 22 (in combination with vincristine, asparaginase, and prednisone).

PETHEMA ALL-96 (Ref):

Adolescents ≥15 years:

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

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

Manufacturer's labeling: Remission induction:

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

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

Acute lymphoblastic leukemia, T cell

Acute lymphoblastic leukemia, T cell (T-ALL):

AALL0434 (Ref): Newly diagnosed: Children and Adolescents: Induction: IV: 25 mg/m2/dose on days 1, 8, 15, 22 (in combination with vincristine, prednisone, pegaspargase, intrathecal methotrexate, and cytarabine).

Acute myelogenous leukemia

Acute myelogenous leukemia (AML):

AAML0531 (Ref): Newly diagnosed:

Note: Some aspects of protocol dosing based on previous reports (Ref).

Infants and Children with BSA <0.6 m2: Induction I and Induction II: IV: 1.67 mg/kg/dose on days 1, 3, 5 (in combination with cytarabine and etoposide).

Children and Adolescents with BSA ≥0.6 m2: Induction I and Induction II: IV: 50 mg/m2/dose on days 1, 3, and 5 (in combination with cytarabine and etoposide).

AAML0431 (Ref): Patients with Down syndrome <4 years of age at time of AML diagnosis:

Infants and Children ≤3 years: Induction I, III, and IV: IV: 0.67 mg/kg/day as a continuous infusion on days 1 to 4 (96 hours total) (in combination with cytarabine and thioguanine).

Children >3 to <4 years: Induction I, III, and IV: IV: 20 mg/m2/day as a continuous infusion on days 1 to 4 (96 hours total) (in combination with cytarabine and thioguanine).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

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

The following adjustments have also been recommended (Ref):

Infants, Children, and Adolescents:

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

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

Dosing: Liver Impairment: Pediatric

The manufacturer's labeling recommends the following adjustments: All patients:

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 based on experience from adult patients (Ref): All patients:

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.

Dosing: Adult

(For additional information see "Daunorubicin: Drug information")

Dosage guidance:

Safety: 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 (Ref). Actively manage modifiable cardiac risk factors (smoking, hypertension, diabetes, dyslipidemia, obesity) before initiating treatment (Ref). Ensure adequate hydration and consider use of antihyperuricemic prophylaxis in patients at risk for tumor lysis syndrome.

Clinical considerations: Daunorubicin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).

Acute lymphocytic leukemia

Acute lymphocytic leukemia (off-label dosing):

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

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

GRAALL-2005: Adults ≤60 years of age: Note: Rituximab is included if CD20-positive (Ref).

Induction: IV: 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) (Ref).

Late intensification: IV: 30 mg/m2 on days 1, 2, and 3 and on days 15 and 16 (in combination with prednisone, vincristine, asparaginase, cyclophosphamide, and G-CSF support) (Ref).

MRC UKALLXII/ECOG E2993: Adults <60 years of age:

Induction (Phase I): IV: 60 mg/m2 on days 1, 8, 15, and 22 (in combination with vincristine, asparaginase, and prednisone) (Ref).

Consolidation (Cycle 3): IV: 25 mg/m2 on days 1, 8, 15, and 22 (in combination with cyclophosphamide, cytarabine, and thioguanine) (Ref).

PETHEMA ALL-96: Adults ≤30 years of age:

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

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

Protocol 8707: Adults ≤60 years of age: IV: Induction and Consolidation 2A cycles: 60 mg/m2 on days 1, 2, and 3 (in combination with vincristine, prednisone, and an asparaginase product). 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 (Ref).

Acute myeloid leukemia

Acute myeloid leukemia (off-label dosing):

CCG 2891: Adults <21 years of age:

Induction: IV: 20 mg/m2/day continuous infusion on days 0 to 4 and 10 to 14 (in combination with dexamethasone, cytarabine, thioguanine, and etoposide) (Ref).

Consolidation: IV: 20 mg/m2/day continuous infusion on days 0 to 4 and 10 to 14 (in combination with dexamethasone, cytarabine, thioguanine, and etoposide) (Ref).

Cytarabine/daunorubicin (7 + 3): Induction: IV: 60 to 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 as a second induction course was administered (in combination with cytarabine) (Ref).

Cytarabine/daunorubicin (5 + 2): Consolidation/re-induction (postremission): IV: 45 mg/m2 on days 1 and 2 (in combination with cytarabine) for 2 courses (Ref).

Gemtuzumab ozogamicin/cytarabine/daunorubicin (CD33-positive AML): Adults 50 to 70 years of age:

Induction: IV: 60 mg/m2 on days 1, 2, and 3 (in combination with cytarabine and gemtuzumab ozogamicin); if >10% persistent leukemic blasts observed at day 15 bone marrow biopsy, a second induction course of 60 mg/m2/day for 2 days (in combination with cytarabine and G-CSF support) was administered (Ref).

Consolidation: IV: 60 mg/m2 on day 1 of consolidation course 1 and 60 mg/m2 on days 1 and 2 of consolidation course 2 (in combination with cytarabine and gemtuzumab ozogamicin) (Ref). Refer to protocol for dosage modification details.

Midostaurin/cytarabine/daunorubicin (FLT3 mutated AML): Adults <60 years of age: Induction: IV: 60 mg/m2 on days 1, 2, and 3 (in combination with cytarabine and midostaurin) for 1 or 2 cycles (Ref). Refer to protocol for dosage modification details.

Acute promyelocytic leukemia

Acute promyelocytic leukemia (off-label dosing):

Induction: Adults: IV: 50 mg/m2 on days 3, 4, 5, and 6 (in combination with ATRA [tretinoin] and cytarabine) (Ref) or 60 mg/m2 on days 3, 4, and 5 (in combination with ATRA and cytarabine) (Ref).

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) (Ref) 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) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Significant kidney function impairment may result in increased toxicities.

Scr >3 mg/dL: Administer 50% of normal dose (Ref).

CrCl 30 to 50 mL/minute: Administer 75% of original dose (Ref).

CrCl <30 mL/minute: Administer 50% of original dose (Ref).

Hemodialysis: Administer 50% of original dose (Ref).

Dosing: Liver Impairment: Adult

Note: Significant hepatic function impairment may result in increased toxicities.

Serum bilirubin 1.2 to 3 mg/dL: Administer 75% of dose (Ref).

Serum bilirubin >3 mg/dL: Administer 50% of dose (Ref), although some sources recommend avoiding daunorubicin use with serum bilirubin >5 mg/dL (Ref).

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Cardiotoxicity (including cardiomyopathy, ECG abnormality, heart failure, myocarditis, pericarditis) (Harrison 1976)

Dermatologic: Alopecia (Matthews 1972), contact dermatitis, hyperpigmentation (Pol 2010), leukonychia (Shelley 1997), nail bed changes (pigmentation) (Anderson 1992), skin pigmentation (Anderson 1992), skin rash, Stevens-Johnson syndrome (Shakya 2021), urticaria

Gastrointestinal: Abdominal pain (Matthews 1972), diarrhea (Matthews 1972), nausea (Matthews 1972), stomatitis (Matthews 1972), vomiting

Genitourinary: Red urine discoloration (Matthews 1972)

Hematologic & oncologic: Bone marrow depression (including anemia, neutropenia, thrombocytopenia) (Matthews 1972)

Contraindications

Hypersensitivity to daunorubicin or any component of the formulation.

Canadian labeling: Patients who exhibit myocardial lesions or those ≥75 years of age.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Daunorubicin may cause severe bone marrow suppression 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.

• Cardiomyopathy: Daunorubicin 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 cessation of treatment). According to the manufacturer's labeling, the incidence of myocardial toxicity increases as the total cumulative (lifetime) doses 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.

- According to American Society of Clinical Oncology 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 age ≥60 years at cancer treatment, or compromised cardiac function (eg, borderline low LVEF [50% to 55%], history of myocardial infarction, 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 age ≥60 years at time of treatment and 2 or more cardiovascular risk factors (smoking, hypertension, diabetes, dyslipidemia, or obesity) during or after treatment.

• Extravasation: Vesicant; if extravasation occurs, severe local tissue damage leading to ulceration and necrosis, and pain may occur. For IV administration only. Daunorubicin is 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.

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

• Tumor lysis syndrome: May cause tumor lysis syndrome and hyperuricemia.

Special populations:

• Older adult: Cardiotoxicity may occur more frequently in older adults. 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. 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 2018]). 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.

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

Warnings: Additional Pediatric Considerations

Pediatric patients are at increased risk for developing delayed cardiac toxicity and congestive heart failure during early adulthood due to an increasing census of long-term survivors; risk factors include: Young treatment age (<5 years), cumulative exposure, and concomitant cardiotoxic therapy. Up to 40% of pediatric patients may have subclinical cardiac dysfunction and 5% to 10% may develop heart failure. Long-term monitoring is recommended for all pediatric patients (COG 2018).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous [preservative free]:

Generic: 50 mg/10 mL (10 mL)

Solution, Intravenous, as hydrochloride:

Generic: 20 mg/4 mL (4 mL [DSC])

Solution, Intravenous, as hydrochloride [preservative free]:

Generic: 20 mg/4 mL (4 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (DAUNOrubicin HCl Intravenous)

20 mg/4 mL (per mL): $39.34 - $40.24

50 mg/10 mL (per mL): $37.05 - $40.24

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.

Dosage Forms: Canada

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

Solution, Intravenous, as hydrochloride:

Generic: 20 mg/4 mL (4 mL)

Solution Reconstituted, Intravenous:

Cerubidine: 20 mg (1 ea)

Administration: Pediatric

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

Parenteral: Administration rate/technique may vary by protocol. May administer IV push over 1 to 15 minutes into the tubing of a rapidly infusing IV solution of D5W or NS. Some pediatric protocols use a continuous infusion of the daily dose over 24 hours. Drug is very irritating, do not inject IM or SUBQ. Refer to individual protocol for details, particularly if the patient is receiving dexrazoxane as a cardioprotectant (including timing with respect to dexrazoxane administration); take precautions to minimize extravasation risks.

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.

Administration: Adult

Daunorubicin 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 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 (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).

Hazardous Drugs Handling Considerations

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).

Storage/Stability

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.

Use

Treatment (remission induction) of acute lymphocytic leukemia (ALL) in combination with other chemotherapy (FDA approved in pediatric patients [age not specified] and adults).

Treatment (remission induction) of acute myeloid leukemia (AML) in combination with other chemotherapy (FDA approved in adults).

Medication Safety Issues
Sound-alike/look-alike issues:

DAUNOrubicin may be confused with DACTINomycin, DAUNOrubicin liposomal, DOXOrubicin, DOXOrubicin liposomal, epiRUBicin, IDArubicin, valrubicin

High alert medication:

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).

Metabolism/Transport Effects

Substrate of P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

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.

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

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 Anthracyclines. Risk C: Monitor

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

Reproductive Considerations

Patients should avoid becoming pregnant during therapy. In general, patients who could become pregnant should use effective contraception during systemic anticancer therapy and for 3 to 6 months after the last dose. Patients with partners who could become pregnant should use effective contraception during treatment and for 3 to 6 months after the last dose of systemic anticancer therapy (ESMO [Peccatori 2013]).

Daunorubicin is associated with an intermediate risk of azoospermia and infertility in males (ESMO [Lambertini 2020]). Recommendations are available for fertility preservation of male and female patients to be treated with anticancer agents (ASCO [Oktay 2018]; Klipstein 2020).

Pregnancy Considerations

Daunorubicin crosses the placenta.

Based on data from animal reproduction studies, in utero exposure to daunorubicin may cause fetal harm. Outcome data following maternal use of daunorubicin during pregnancy are available (Fracchiolla 2017; NTP 2013).

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 encourage a multidisciplinary team (obstetrician, neonatologist, oncology team) approach (ESMO [Peccatori 2013]). Guidance is available for the management of acute myeloid leukemia during pregnancy. If daunorubicin is indicated, it should not be administered in the first trimester, but may begin in the second trimester; use between 24 and 32 weeks gestation should consider benefits and risks of therapy (BSH [Ali 2015]).

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 (877-635-4499).

Monitoring Parameters

CBC with differential and platelet count, serum bilirubin, serum uric acid, LFT, ECG, ventricular ejection fraction (echocardiography [ECHO] or multigated radionuclide angiography [MUGA] scan), renal function test; signs/symptoms of extravasation.

Cardiovascular monitoring (ASCO [Armenian 2017]): Adults: 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.

Mechanism of Action

Daunorubicin 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.

Pharmacokinetics (Adult Data Unless Noted)

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

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

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Daunorubicin;
  • (AR) Argentina: Daunoblastina | Daunogobbi | Daunorubicina gp pharm | Daunorubicina kemex | Maxidauno;
  • (AT) Austria: Daunoblastin;
  • (AU) Australia: Daunorubicin | Daunoxome;
  • (BE) Belgium: Cerubidine;
  • (BR) Brazil: Daunoblastina | Evoclass;
  • (CH) Switzerland: Cerubidine | Daunoblastin;
  • (CL) Chile: Cerubidine | Daunorubicina | Daurocina;
  • (CN) China: Daunoblastina | Daunorubicin;
  • (CO) Colombia: Al dauno | Cerubidine | Daunac | Daunorubicina;
  • (CZ) Czech Republic: Cerubidine | Daunoblastina;
  • (DE) Germany: Daunoblastin | Daunorubicin | Daunoxome;
  • (EC) Ecuador: Daunorubicin | Daunorubicina | Maxidauno;
  • (EE) Estonia: Cerubidine | Daunoblastin | Daunoblastina | Daunocyte | Daunorubicin | Daunosin;
  • (EG) Egypt: Daunocin;
  • (ES) Spain: Daunoblastina;
  • (ET) Ethiopia: Daunoplus;
  • (FI) Finland: Cerubidin | Daunoxome;
  • (FR) France: Cerubidine | Daunorubicine Dci | Daunoxome;
  • (GB) United Kingdom: Cerubidin | Daunorubicin | Daunoxome | Trav daunorubicin;
  • (GR) Greece: Daunoblastina;
  • (HK) Hong Kong: Daunoblastina;
  • (HR) Croatia: Daunoblastina;
  • (HU) Hungary: Cerubidine | Rubomycin;
  • (ID) Indonesia: Daunoblastina | Daunocin | Daunorubicin;
  • (IE) Ireland: Cerubidin;
  • (IN) India: Dauneon | Daunocin | Daunomycin | Daunorubitec | Daunotec | Zedaunor;
  • (IT) Italy: Daunoblastina | Daunorubicina | Daunoxome;
  • (JO) Jordan: Daunoblastina;
  • (JP) Japan: Daunomycin;
  • (KR) Korea, Republic of: Cerubidine | Ckd daunorubicin | Daunoblastina | Daunocin;
  • (KW) Kuwait: Daunoblastina;
  • (LB) Lebanon: Cerubidine;
  • (LT) Lithuania: Cerubidine | Daunoblastina;
  • (LV) Latvia: Cerubidine | Daunoblastina;
  • (MA) Morocco: Cerubidine;
  • (MX) Mexico: Daunorubicina | Rubilem | Runabicon;
  • (MY) Malaysia: Daunoblastina | Daunocin | Daunorubicin;
  • (NL) Netherlands: Cerubidine;
  • (NO) Norway: Cerubidin;
  • (NZ) New Zealand: Daunorubicin | Daunorubicin Pfizer;
  • (PE) Peru: Daunocin | Daunorubicina | Daunorubitec;
  • (PK) Pakistan: D-blastin | Daunoblastina | Daunocin | Rubilem;
  • (PL) Poland: Cerubidine | Dauneon | Daunoblastin | Daunocin | Daunomicina | Daunotec | Daunoxome;
  • (PR) Puerto Rico: Cerubidine | Daunorubicin | Daunorubicin HCL;
  • (PT) Portugal: Cerubidine | Daunoblastina | Daunorrubicina;
  • (RO) Romania: Daunoblastina;
  • (RU) Russian Federation: Cerubidine | Daunorubicin lens | Daunoxome | Rubomycin;
  • (SA) Saudi Arabia: Daunoblastina;
  • (SE) Sweden: Cerubidin | Cerubidine;
  • (SG) Singapore: Daunoblastina;
  • (SI) Slovenia: Daunoblastina;
  • (SK) Slovakia: Daunoblastina;
  • (TN) Tunisia: Cerubidine;
  • (TR) Turkey: Daunomicina | Daunosin;
  • (TW) Taiwan: Daunoblastina | Daunomycin;
  • (UA) Ukraine: Daunoblastina | Rubomycin;
  • (UY) Uruguay: Daunorrubicina FU;
  • (ZA) South Africa: Daunoblastin;
  • (ZM) Zambia: Daunorubicin HCL
  1. Ades L, Sanz MA, Chevret S, et al. Treatment of newly diagnosed acute promyelocytic leukemia (APL): a comparison of French-Belgian-Swiss and PETHEMA results. Blood. 2008;111(3):1078-1084. [PubMed 17975017]
  2. Ali S, Jones GL, Culligan DJ, Marsden PJ, Russell N, Embleton ND, Craddock C; British Committee for Standards in Haematology. Guidelines for the diagnosis and management of acute myeloid leukaemia in pregnancy. Br J Haematol. 2015;170(4):487-495. doi:10.1111/bjh.13554 [PubMed 26081614]
  3. Anderson LL, Thomas DE, Berger TG, Vukelja SJ. Cutaneous pigmentation after daunorubicin chemotherapy. J Am Acad Dermatol. 1992;26(2 Pt 1):255-256. doi:10.1016/s0190-9622(08)80301-5 [PubMed 1552062]
  4. Armenian SH, Lacchetti C, Barac A, et al. Prevention and monitoring of cardiac dysfunction in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2017;35(8):893-911. doi:10.1200/JCO.2016.70.5400 [PubMed 27918725]
  5. Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th Ed. American College of Physicians; 2007:98.
  6. Burnett AK, Russell NH, Hills RK, et al. Optimization of chemotherapy for younger patients with acute myeloid leukemia: results of the medical research council AML15 trial. J Clin Oncol. 2013;31(27):3360-3368. doi:10.1200/JCO.2012.47.4874 [PubMed 23940227]
  7. Castaigne S, Pautas C, Terré C, et al; Acute Leukemia French Association. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012;379(9825):1508-1516. doi:10.1016/S0140-6736(12)60485-1 [PubMed 22482940]
  8. Cerubidine (daunorubicin) [product monograph]. Montreal, Quebec, Canada: Searchlight Pharma Inc; October 2022.
  9. Children's Oncology Group (COG). Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. http://www.survivorshipguidelines.org/pdf/2018/COG_LTFU_Guidelines_v5.pdf. Updated October 2018. Accessed March 25, 2021.
  10. Cooper TM, Franklin J, Gerbing RB, et al. AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia: a report from the Children's Oncology Group. Cancer. 2012;118(3):761-769. [PubMed 21766293]
  11. Crom WR, Glynn-Barnhart AM, Rodman JH, et al. Pharmacokinetics of Anticancer Drugs in Children. Clin Pharmacokinet. 1987;12(3):168-213. [PubMed 3555940]
  12. Cuttner J, Mick R, Budman DR, et al. Phase III Trial of Brief Intensive Treatment of Adult Acute Lymphocytic Leukemia Comparing Daunorubicin and Mitoxantrone: A CALGB Study. Leukemia. 1991;5(5):425-431. [PubMed 2033963]
  13. Daunorubicin (daunorubicin hydrochloride injection) [product monograph]. Mississauga, Ontario, Canada: Hikma Canada Limited; June 2023.
  14. Daunorubicin [prescribing information]. Bedford, OH: Bedford Laboratories; June 2013.
  15. Daunorubicin [prescribing information]. Bridgewater, NJ: Hisun Pharmaceuticals; August 2020.
  16. Dupuis LL, Boodhan S, Sung L. Guideline for the Classification of the Acute Emetogenic Potential of Antineoplastic Medication in Pediatric Cancer Patients. Pediatr Blood Cancer. 2011;57:191-198. [PubMed 21465637]
  17. Fernandez HF, Sun Z, Yao X, et al. Anthracycline dose intensification in acute myeloid leukemia. N Engl J Med. 2009;361:1249-1259. [PubMed 19776406]
  18. Floyd J, Mirza I, Sachs B, et al. Hepatotoxicity of Chemotherapy. Semin Oncol. 2006;33(1):50-67. [PubMed 16473644]
  19. Floyd JD, Nguyen DT, Lobins RL, et al. Cardiotoxicity of Cancer Therapy. J Clin Oncol. 2005;23(30):7685-7696. [PubMed 16234530]
  20. Fracchiolla NS, Sciumè M, Dambrosi F, et al. Acute myeloid leukemia and pregnancy: clinical experience from a single center and a review of the literature. BMC Cancer. 2017;17(1):442. doi:10.1186/s12885-017-3436-9 [PubMed 28645262]
  21. Gamis AS, Alonzo TA, Meshinchi S, et al. Gemtuzumab ozogamicin in children and adolescents with de novo acute myeloid leukemia improves event-free survival by reducing relapse risk: results from the randomized phase III Children’s Oncology Group trial AAML0531. J Clin Oncol. 2014;32(27):3021-3032. [PubMed 25092781]
  22. Gibson BE, Webb DK, Howman AJ, et al. Results of a randomized trial in children with acute myeloid leukaemia: medical research council AML12 trial. Br J Haematol. 2011;155(3):366-376. [PubMed 21902686]
  23. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
  24. Guest EM, Aplenc R, Sung L, et al. Gemtuzumab ozogamicin (GO) in infants with acute myeloid leukemia (AML) - combined results from the Children's Oncology Group (COG) trials. AAML03P1 and AAML0531. Blood. 2014;124:377.
  25. Harrison DT, Sanders LA. Letter: Pericarditis in a case of early daunorubicin cardiomyopathy. Ann Intern Med. 1976;85(3):339-341. doi:10.7326/0003-4819-85-3-339 [PubMed 1066982]
  26. Herrstedt J, Clark-Snow R, Ruhlmann CH, et al; participants of the MASCC/ESMO Consensus Conference 2022. 2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting. ESMO Open. 2024;9(2):102195. doi:10.1016/j.esmoop.2023.102195 [PubMed 38458657]
  27. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO guideline update. J Clin Oncol. 2020;38(24):2782-2797. doi:10.1200/JCO.20.01296 [PubMed 32658626]
  28. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  29. Huguet F, Chevret S, Leguay T, et al; Group of Research on Adult ALL (GRAALL). Intensified therapy of acute lymphoblastic leukemia in adults: report of the randomized GRAALL-2005 clinical trial. J Clin Oncol. 2018;36(24):2514-2523. doi:10.1200/JCO.2017.76.8192 [PubMed 29863974]
  30. Huguet F, Lequay T, Raffoux E, et al. Pediatric-inspired therapy in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: the GRAALL-2003 study. J Clin Oncol. 2009;27:911-918. [PubMed 19124805]
  31. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  32. Keefe DL. Anthracycline-Induced Cardiomyopathy. Semin Oncol. 2001;28(4)(suppl 12):2-7. [PubMed 11552224]
  33. Klipstein S, Fallat ME, Savelli S; Committee on Bioethics; Section on Hematology/Oncology; Section on Surgery. Fertility preservation for pediatric and adolescent patients with cancer: medical and ethical considerations. Pediatrics. 2020;145(3):e20193994. doi:10.1542/peds.2019-3994 [PubMed 32071259]
  34. Krens SD, Lassche G, Jansman FGA, et al. Dose recommendations for anticancer drugs in patients with renal or hepatic impairment. Lancet Oncol. 2019;20(4):e200-e207. doi:10.1016/S1470-2045(19)30145-7 [PubMed 30942181]
  35. Lambertini M, Peccatori FA, Demeestere I, et al; ESMO Guidelines Committee. Fertility preservation and post-treatment pregnancies in post-pubertal cancer patients: ESMO clinical practice guidelines. Ann Oncol. 2020;31(12):1664-1678. doi:10.1016/j.annonc.2020.09.006 [PubMed 32976936]
  36. Larsen EC, Devidas M, Chen S, et al. Dexamethasone and high-dose methotrexate improve outcome for children and young adults with high-risk B-acute lymphoblastic leukemia: A report from Children's Oncology Group Study AALL0232. J Clin Oncol. 2016;34(20):2380-2388. doi:10.1200/JCO.2015.62.4544 [PubMed 27114587]
  37. Larson RA, Dodge RK, Burns CP, et al. A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: cancer and leukemia group B study 8811. Blood. 1995;85:2025-2037. [PubMed 7718875]
  38. Linker C, Damon L, Ries C, et al. Intensified and shortened cyclical chemotherapy for adult acute lymphoblastic leukemia. J Clin Oncol. 2002;20:2464-2471. [PubMed 12011123]
  39. Loeffen EAH, van Dalen EC, Mulder RL, et al; Anthracycline Cardiotoxicity Working Group. The duration of anthracycline infusion should be at least one hour in children with cancer: A clinical practice guideline. Pediatr Blood Cancer. 2018;65(2). doi:10.1002/pbc.26867 [PubMed 29077260]
  40. Lowenberg B, Ossenkoppele GJ, van Putten W, et al. High-dose daunorubicin in older patients with acute myeloid leukemia. N Engl J Med. 2009;361:1235-1248. [PubMed 19776405]
  41. Lyon AR, López-Fernández T, Couch LS, et al; ESC Scientific Document Group. 2022 ESC guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022;43(41):4229-4361. doi:10.1093/eurheartj/ehac244 [PubMed 36017568]
  42. Masaoka T, Ogawa M, Yamada K, et al. A Phase II Comparative Study of Idarubicin Plus Cytarabine Versus Daunorubicin Plus Cytarabine in Adult Acute Myeloid Leukemia. Semin Hematol. 1996;33(4)(suppl 3):12-17. [PubMed 8916311]
  43. Matthews RN, Colebatch JH. Daunorubicin. Results in childhood leukaemia. Arch Dis Child. 1972;47(252):272-277. doi:10.1136/adc.47.252.272 [PubMed 4502569]
  44. Maury S, Chevret S, Thomas X, et al; for GRAALL. Rituximab in B-lineage adult acute lymphoblastic leukemia. N Engl J Med. 2016;375(11):1044-1053. doi:10.1056/NEJMoa1605085 [PubMed 27626518]
  45. Morgan C, Tillett T, Braybrooke J, et al. Management of Uncommon Chemotherapy-Induced Emergencies. Lancet Oncol. 2011;12(8):806-814. [PubMed 21276754]
  46. Mouridsen HT, Langer SW, Buter J, et al. Treatment of Anthracycline Extravasation With Savene (Dexrazoxane): Results From Two Prospective Clinical Multicentre Studies. Ann Oncol. 2007;18(3):546-550. [PubMed 17185744]
  47. Nachman JB, La MK, Hunger SP, et al. Young adults with acute lymphoblastic leukemia have an excellent outcome with chemotherapy alone and benefit from intensive postinduction treatment: a report from the children's oncology group. J Clin Oncol. 2009;27(31):5189-5194. doi:10.1200/JCO.2008.20.8959 [PubMed 19805689]
  48. National Toxicology Program (NTP). NTP monograph: developmental effects and pregnancy outcomes associated with cancer chemotherapy use during pregnancy. NTP Monogr. 2013;(2):i-214. [PubMed 24736875]
  49. Oktay K, Harvey BE, Partridge AH, et al. Fertility preservation in patients with cancer: ASCO clinical practice guideline update. J Clin Oncol. 2018;36(19):1994-2001. doi:10.1200/JCO.2018.78.1914 [PubMed 29620997]
  50. Ovesen JL, Sam­mons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  51. Paw Cho Sing E, Robinson PD, Flank J, et al. Classification of the acute emetogenicity of chemotherapy in pediatric patients: a clinical practice guideline. Pediatr Blood Cancer. 2019;66(5):e27646. doi:10.1002/pbc.27646 [PubMed 30729654]
  52. Peccatori FA, Azim HA Jr, Orecchia R, et al; ESMO Guidelines Working Group. Cancer, pregnancy and fertility: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(suppl 6):S160-S170. doi:10.1093/annonc/mdt199 [PubMed 23813932]
  53. Pérez Fidalgo JA, García Fabregat L, Cervantes A, et al. Management of Chemotherapy Extravasation: ESMO-EONS Clinical Practice Guidelines. Ann Oncol. 2012;23(suppl 7):167-173. [PubMed 22997449]
  54. Pol RR, Wright A, Hill A. Daunorubicin-induced hyperpigmentation. Br J Haematol. 2010;151(5):414. doi:10.1111/j.1365-2141.2010.08358.x [PubMed 21029070]
  55. Powell BL, Moser B, Stock W, et al. Arsenic trioxide improves event-free and overall survival for adults with acute promyelocytic leukemia: North American Leukemia Intergroup Study C9710. Blood. 2010;116:3751-3757. [PubMed 20705755]
  56. Refer to manufacturer’s labeling.
  57. Ribera JM, Oriol A, Sanz MA, et al. Comparison of the results of the treatment of adolescents and young adults with standard-risk acute lymphoblastic leukemia with the Programa Espanol de Tratamiento en Hematologia pediatric-based protocol ALL-96. J Clin Oncol. 2008;26:1843-1849. [PubMed 18398150]
  58. Rowe JM, Buck G, Burnett AK, et al. Induction therapy for adults with acute lymphoblastic leukemia: results of more than 1500 patients from the international ALL trial: MRC UKALL XII/ECOG E2993. Blood. 2005;106:3760-3767. [PubMed 16105981]
  59. Shakya P, Sharma Nepal A. Daunorubicin induced Stevens-Johnson syndrome: a case report. Clin Case Rep. 2021;9(7):e04475. doi:10.1002/ccr3.4475 [PubMed 34295492]
  60. Shelley WB, Humphrey GB. Transverse leukonychia (Mees' lines) due to daunorubicin chemotherapy. Pediatr Dermatol. 1997;14(2):144-145. doi:10.1111/j.1525-1470.1997.tb00222.x [PubMed 9144702]
  61. Speth PA, Minderman H, Haanen C. Idarubicin v Daunorubicin: Preclinical and Clinical Pharmacokinetic Studies. Semin Oncol. 1989;16(1)(suppl 2):2-9. [PubMed 2648580]
  62. Steinherz PG, Redner A, Steinherz L, Meyers P, Tan C, Heller G. Development of a new intensive therapy for acute lymphoblastic leukemia in children at increased risk of early relapse. The Memorial Sloan-Kettering-New York-II protocol. Cancer. 1993;72(10):3120-3130. doi:10.1002/1097-0142 [PubMed 8221579]
  63. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation. N Engl J Med. 2017;377(5):454-464. doi:10.1056/NEJMoa1614359 [PubMed 28644114]
  64. Taub JW, Berman JN, Hitzler JK, et al. Improved outcomes for myeloid leukemia of Down syndrome: a report from the Children's Oncology Group AAML0431 trial. Blood. 2017;129(25):3304-3313. doi:10.1182/blood-2017-01-764324 [PubMed 28389462]
  65. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  66. Weick JK, Kopecky KJ, Appelbaum FR, et al. A Randomized Investigation of High-Dose Versus Standard-Dose Cytosine Arabinoside With Daunorubicin in Patients With Previously Untreated Acute Myeloid Leukemia: A Southwest Oncology Group Study. Blood. 1996;88(8):2841-2851. [PubMed 8874180]
  67. Wiernik PH, Banks PL, Case DC Jr, et al. Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood. 1992;79(2):313-319. [PubMed 1730080]
  68. Winter SS, Dunsmore KP, Devidas M, et al. Improved survival for children and young adults with T-lineage acute lymphoblastic leukemia: results from the Children's Oncology Group AALL0434 methotrexate randomization. J Clin Oncol. 2018;36(29):2926-2934. doi:10.1200/JCO.2018.77.7250 [PubMed 30138085]
  69. Woods WG, Kobrinsky N, Buckley JD, et al. Timed-sequential induction therapy improves postremission outcome in acute myeloid leukemia: a report from the Children’s Cancer Group. Blood. 1996;87:4979-4989. [PubMed 8652810]
  70. Woods WG, Ruymann FB, Lampkin BC, et al. The Role of Timing of High-Dose Cytosine Arabinoside Intensification and of Maintenance Therapy in the Treatment of Children With Acute Nonlymphocytic Leukemia. Cancer. 1990;66(6):1106-1113. [PubMed 2205352]
  71. Zamorano JL, Lancellotti P, Rodriguez Muñoz D, et al. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016;37(36):2768-2801. [PubMed 27567406]
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