daunorubicin (Rx)

Brand and Other Names:Cerubidine

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 5mg/mL

powder for injection

  • 20mg

Acute Nonlymphocytic Leukemia

In combination with cytarabine 100 mg/m²/day IV for 7 days first course, for 5 days subsequent courses  

<60 years old: 45 mg/m² IVP days 1, 2, 3 first course; days 1, 2 subsequent courses

>60 years old: 30 mg/m² IVP days 1, 2, 3 first course; days 1, 2 subsequent courses

Monitor: Cardiac, renal, hepatic function

Acute Lymphocytic Leukemia

45 mg/m² IVP days 1, 2, 3  

Monitor: Cardiac, renal, hepatic function

Renal Impairment

>3 mg/dL serum creatinine: Administer 50% regular dose

Hepatic Impairment

< 1.2 mg/dL serum bilirubin: Dose adjustment not necessary

1.2-3 mg/dL serum bilirubin: 75% of regular dose

> 3 mg/dL serum bilirubin: 50% of regular dose

Administration

Limit lifetime dose to <550 mg/m² (including doses of related drugs) to reduce risk of cardiotoxicity (400 mg/m² for patients who received irradiation of cardiac region)

Dosage Forms & Strengths

injectable solution

  • 5mg/mL

powder for injection

  • 20mg

Acute Nonlymphocytic Leukemia

<2 years old or <0.5 m² BSA: 1 mg/kg IVP qWeek  

>2 years old or >0.5 m² BSA: 25 mg/m² IVP qWeek

Monitor: Cardiac, renal, hepatic function

Acute Lymphocytic Leukemia

<2 years old or <0.5 m² BSA: 1 mg/kg IVP qWeek

>2 years old or >0.5 m² BSA: 25 mg/m² IVP qWeek  

Monitor: Cardiac, renal, hepatic function

Administration

Limit lifetime dose for children 2 years old or older to 300 mg/sq.meter, and for children <2 years old to 10 mg/kg to avoid irreversible cardiotoxicity

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Interactions

Interaction Checker

and daunorubicin

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              Serious - Use Alternative (15)

              • adenovirus types 4 and 7 live, oral

                daunorubicin decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • darolutamide

                darolutamide will increase the level or effect of daunorubicin by Other (see comment). Avoid or Use Alternate Drug. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).

              • eliglustat

                eliglustat increases levels of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

              • erdafitinib

                erdafitinib will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

              • influenza virus vaccine quadrivalent, adjuvanted

                daunorubicin decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                daunorubicin decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • lasmiditan

                lasmiditan increases levels of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

                lasmiditan increases levels of daunorubicin by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates.

              • leniolisib

                leniolisib will increase the level or effect of daunorubicin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

              • palifermin

                palifermin increases toxicity of daunorubicin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • ropeginterferon alfa 2b

                ropeginterferon alfa 2b, daunorubicin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • sotorasib

                sotorasib will decrease the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              • tepotinib

                tepotinib will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

              • tofacitinib

                daunorubicin, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • trastuzumab

                trastuzumab, daunorubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, daunorubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.

              Monitor Closely (66)

              • acalabrutinib

                acalabrutinib increases levels of daunorubicin by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.

                acalabrutinib, daunorubicin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • amiodarone

                amiodarone will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • apalutamide

                apalutamide will decrease the level or effect of daunorubicin by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces BCRP and may decrease systemic exposure of drugs that are BCRP substrates.

              • atorvastatin

                atorvastatin will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • belatacept

                belatacept and daunorubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • berotralstat

                berotralstat will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

              • bevacizumab

                bevacizumab, daunorubicin. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.

              • bosutinib

                bosutinib increases levels of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • cholera vaccine

                daunorubicin, cholera vaccine. immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • clarithromycin

                clarithromycin will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • crizotinib

                crizotinib increases levels of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • cyclosporine

                cyclosporine will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • dengue vaccine

                daunorubicin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                daunorubicin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • dronedarone

                dronedarone will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • elagolix

                elagolix will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • eluxadoline

                eluxadoline increases levels of daunorubicin by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered BCRP substrates.

              • encorafenib

                encorafenib will increase the level or effect of daunorubicin by Other (see comment). Modify Therapy/Monitor Closely. Encorafenib (a BCRP inhibitor) may increase the concentration and toxicities of BCRP substrates. Closely monitor for signs and symptoms of increased exposure and consider adjusting the dose of these substrates.

              • erythromycin base

                erythromycin base will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • fingolimod

                daunorubicin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • fostamatinib

                fostamatinib will increase the level or effect of daunorubicin by decreasing metabolism. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of BCRP substrate drugs. Monitor for toxicities of BCRP substrate drug that may require dosage reduction when given concurrently with fostamatinib.

                fostamatinib will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.

              • fostemsavir

                fostemsavir will increase the level or effect of daunorubicin by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.

              • glecaprevir/pibrentasvir

                glecaprevir/pibrentasvir will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                glecaprevir/pibrentasvir will increase the level or effect of daunorubicin by decreasing metabolism. Use Caution/Monitor. Glecaprevir/pibrentasvir may increase plasma concentration of BCRP substrates.

              • hydroxyurea

                daunorubicin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • ifosfamide

                ifosfamide, daunorubicin. Other (see comment). Use Caution/Monitor. Comment: Risk of developing cardiotoxic effects increase in patients with prior or concomitant treatment with other cardiotoxic agents.

              • istradefylline

                istradefylline will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

              • itraconazole

                itraconazole will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ivacaftor

                ivacaftor increases levels of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.

              • ketoconazole

                ketoconazole will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • lapatinib

                lapatinib will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • levoketoconazole

                levoketoconazole will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • lomitapide

                lomitapide increases levels of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.

              • lonafarnib

                lonafarnib will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

              • meningococcal group B vaccine

                daunorubicin decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • nefazodone

                nefazodone will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • nicardipine

                nicardipine will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • nilotinib

                nilotinib will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ofatumumab SC

                ofatumumab SC, daunorubicin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                daunorubicin and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • osimertinib

                osimertinib will increase the level or effect of daunorubicin by Other (see comment). Modify Therapy/Monitor Closely. Osimertinib is an inhibitor of BCRP transport. Caution if coadministered with sensitive BCRP substrates.

              • oteseconazole

                oteseconazole will increase the level or effect of daunorubicin by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • ponatinib

                ponatinib increases levels of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

                ponatinib increases levels of daunorubicin by Other (see comment). Use Caution/Monitor.

              • quinidine

                quinidine will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ranolazine

                ranolazine will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • regorafenib

                regorafenib will increase the level or effect of daunorubicin by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.

              • rifampin

                rifampin will decrease the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ritonavir

                ritonavir will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • safinamide

                safinamide will increase the level or effect of daunorubicin by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.

              • sarecycline

                sarecycline will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

              • siponimod

                siponimod and daunorubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                daunorubicin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • sofosbuvir/velpatasvir

                sofosbuvir/velpatasvir will increase the level or effect of daunorubicin by Other (see comment). Use Caution/Monitor. Velpatasvir is an inhibitor of the drug transporter BCRP. Coadministration may increase systemic exposure of drugs that are BCRP substrates.

              • St John's Wort

                St John's Wort will decrease the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • stiripentol

                stiripentol will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

                stiripentol will increase the level or effect of daunorubicin by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered.

              • tacrolimus

                tacrolimus will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • tafamidis

                tafamidis will increase the level or effect of daunorubicin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tafamidis meglumine

                tafamidis meglumine will increase the level or effect of daunorubicin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • trastuzumab

                trastuzumab, daunorubicin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, daunorubicin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trazodone

                trazodone will decrease the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • tucatinib

                tucatinib will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

              • vemurafenib

                vemurafenib increases levels of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • verapamil

                verapamil will increase the level or effect of daunorubicin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              Minor (0)

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                Adverse Effects

                >10%

                Nausea

                Vomiting

                Arrhythmias

                Discoloration of urine

                Alopecia

                1-10%

                Injection site skin flare

                Hyperuricemia

                GI ulceration

                Diarrhea

                <1%

                Arrhythmia

                Cardiomyopathy

                Bilirubin increased

                Pruritus

                Urticaria

                Frequency Not Defined

                Fever

                CHF

                Flushing

                Stomatitis

                Myelosuppression

                Rash

                Hyperpigmentation of previously radiated areas

                Transverse pigmentation of fingernails and toenails

                Fertility impairment

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                Warnings

                Black Box Warnings

                The drug should be administered under the supervision of an experienced leukemia-chemotherapy physician. Physician must be capable of responding rapidly to severe hemorrhagic conditions or overwhelming infection.

                Administer daunorubicin into a rapidly flowing IV infusion. Severe local tissue necrosis will result if extravasation occurs. Do not administer IM or SC.

                Cumulative dosage that exceeds 400 to 550 mg/m² in adults, 300 mg/m² >2 years of age, or 10 mg/kg in children <2 years of age may result in a severe and potentially fatal myocardial toxicity including congestive heart failure; this may occur during therapy or several months to years after therapy.

                Severe myelosuppression that could lead to infection or hemorrahage may occur when used at therapeutic doses

                Dosage adjustment recommended in patients with renal or hepatic impairment

                Contraindications

                Hypersensitivity

                Active infection

                IM or SC administration (vesicant)

                Patients who have received max cumulative dose of daunorubicin or doxorubicin

                Patients with preexisting myelosuppression from other drug treatments

                Cautions

                Risk of severe cardiotoxicity (including CHF) & myelosuppression

                Caution in hepatic/renal impairment

                Children may be more sensitive to cardiotoxic effects than adults

                Avoid pregnancy

                Secondary leukemias reported when used in combination with radiation or chemotherapy

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                Pregnancy & Lactation

                Pregnancy Category: D

                Lactation: excretion in milk unknown/not recommended

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Anthracycline; intercalates between DNA base pairs, impairs topoisomerase II function and subsequently inhibits DNA and RNA replication

                Pharmacokinetics

                Protein Bound: 50-60%

                Half-life: 14-20 hr (parent drug), 24-48 hr (daunorubicinol)

                Vd: 20-39.2 L/kg

                Metabolism: Hepatic

                Metabolites: Daunorubicinol

                Clearance: 17.3 mL/min

                Excretion: Feces (40%) & urine (25%)

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                Administration

                IV Incompatibilities

                Additive: dexamethasone sodium phosphate, heparin

                Y-site: allopurinol, aztreonam, cefepime, fludarabine, piperacillin/tazobactam

                IV Compatibilities

                Additive: cytarabine/etoposide, hydrocortisone Na-succinate

                Y-site: amifostine, etoposide phosphate, filgrastim, gemcitabine, granisetron, melphalan, methotrexate, ondansetron, Na-bicarb, teniposide, thiotepa, vinorelbine

                IV Preparation

                Reconstitute 20 mg vial with 4 mL SWI to a final concentration of 5 mg/mL

                IV Administration

                Vesicant, never administer IM or SC

                IVP: desired dose is withdrawn into a syringe containing 10-15 mL NS, then injected over 2-3 min into the tubing or sidearm of a freely flowing IV infusion of NS or D5W

                Avoid small veins, swollen or edematous extremities, & areas overlying joints & tendons as inj sites

                Has also been diluted in 100 mL of D5W or NS & infused over 30-45 min

                Flush with 5-10 mL of IV solution before & after drug administration

                Extravasation Management

                Terminate injection or infusion immediately & aspirate back as much as possible

                Apply cold pack w/circulating ice water, ice pack or cryogel pack to extravasation site for 15-20 min QID x 24-48 hr

                Elevate site for 48 hr, then resume normal activity

                Extravasation of <1-2 mL often heal spontaneously. If >3 mL, ulceration may occur.

                Protect site from heat & sunlight

                Varied results in studies using 99% DMSO to treat extravasation, follow institutional policy

                If pain, erythema, &/or swelling persist beyond 48 hr, refer pt immediately to plastic surgeon for consultation & possible debridement

                See also Totect

                Storage

                Store intact vials at room temp

                Protect from light

                Reconstituted solution stable for 24 hr at room temp or 48 hr if refrigerated

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                daunorubicin intravenous
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                5 mg/mL vial
                daunorubicin intravenous
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                5 mg/mL vial
                daunorubicin intravenous
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                5 mg/mL vial
                daunorubicin intravenous
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                5 mg/mL vial
                daunorubicin intravenous
                -
                5 mg/mL vial
                daunorubicin intravenous
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                5 mg/mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                daunorubicin intravenous

                DAUNORUBICIN - INJECTION

                (dawn-oh-REWB-eh-sin)

                COMMON BRAND NAME(S): Cerubidine

                WARNING: Daunorubicin must be given only by injection into a vein. This medication must not be given by injection into a muscle or under the skin. If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor right away if you notice redness, pain, or swelling at or near the injection site.This medication may rarely cause serious (rarely fatal) heart problems (including heart failure). This may occur both during treatment or months to years after treatment is completed. The risk of heart problems is affected by your dose, medical history (including previous heart disease, radiation treatment to the chest area), and previous use of this and other drugs (including doxorubicin). Tell your doctor right away if you notice symptoms such as irregular heartbeat, shortness of breath, swelling ankles/feet, unusual tiredness, or unusual/sudden weight gain.Daunorubicin may cause certain severe blood and bone marrow disorders (low red blood cells/white blood cells/platelets). This can affect your body's ability to stop bleeding or fight infection. Tell your doctor right away if you develop easy bleeding/bruising or signs of infection (such as sore throat that doesn't go away, fever, chills).Very rarely, people with cancer who are treated with this type of medication have developed other cancers (such as secondary leukemia). The risk may be increased when this medication is given with certain anti-cancer drugs or radiation treatment. Consult your doctor for more details.Before starting treatment with this medication, tell your doctor if you have liver or kidney problems. Your dose may need to be adjusted.

                USES: Daunorubicin is used to treat leukemia and other cancers. It belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells.

                HOW TO USE: This medication is given by injection into a vein by a health care professional. Dosage is based on your medical condition, body size, and response to treatment.If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelids and flush with water for 15 minutes, then get medical help right away. Caregivers should take precautions (such as wearing gloves) to prevent contact with the patient's urine and other body fluids.Drink plenty of fluids while using this medication unless otherwise directed by your doctor. Doing so helps decrease the risk of certain side effects (such as increased uric acid).

                SIDE EFFECTS: See also Warning section.Nausea, vomiting, constipation, diarrhea, and loss of appetite may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.This medication may cause your urine to turn a reddish color. This is a normal, harmless effect of the drug and should not be mistaken for blood in your urine.Temporary hair loss is a common side effect. Normal hair growth should return after treatment has ended.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: unusual bleeding/bruising (such as small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds).Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using daunorubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (such as doxorubicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (such as anemia, low blood cell counts), gout, heart disease (such as heart failure, irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).Daunorubicin can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using daunorubicin before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children may be more sensitive to the side effects of this drug, especially effects on the heart.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using daunorubicin. Daunorubicin may harm an unborn baby. Men and women using this medication should ask about reliable forms of birth control during treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other anti-cancer drugs (especially anthracyclines such as doxorubicin), cyclophosphamide.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Lab and/or medical tests (such as kidney/liver function, complete blood count, EKG) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.