another time [2:<2 years of age or with body surface area> <0.5 m 2 , calculate daunorubicin dosage (1 mg/kg) on basis of body weight rather than body surface area. 125 215 Consult published protocols for dosages for prednisone, vincristine, or other antineoplastic agents in these children. Conventional daunorubicin hydrochloride: In children 2 years of age and with body surface area 0.5 m 2 , 25 mg/m 2 IV on day 1 every week, in combination with vincristine (1.5 mg/m 2 IV on day 1 every week) and prednisone (40 mg/m 2 orally daily). 125 215 Generally, complete remission is obtained within 4 such courses; however, if after 4 courses, the patient is in partial remission, an additional 1 or 2 (if necessary) courses may be given in effort to obtain complete remission. 125 215 Other regimens have been used; dosage generally has ranged from 25 45 mg/m 2 , with frequency of administration dependent on specific regimen employed; consult published protocols. f Consolidation and Cumulative Dosage Initiate appropriate consolidation therapy after induction of a complete remission. f Total dosage administered should take into account previous or concomitant therapy with other potentially cardiotoxic agents or with related drugs (e.g., doxorubicin). 125 (See Myocardial Toxicity in Boxed Warning and also Prescribing Limits under Dosage and Administration.) Adults ALL Representative Dosage Schedule and Combination Therapy for Remission Induction IV Conventional daunorubicin hydrochloride: 45 mg/m 2 IV on days 1, 2, and 3, in combination with vincristine (2 mg IV on days 1, 8, and 15), prednisone (40 mg/m 2 orally daily on days 1 22, then tapered between days 22 29), and asparaginase (500 units/kg IV daily for 10 days on days 22 32). 215 Consolidation and Cumulative Dosage Initiate appropriate consolidation therapy after induction of a complete remission. f Total dosage administered should take into account previous or concomitant therapy with other potentially cardiotoxic agents or with related drugs (e.g., doxorubicin). 125 (See Myocardial Toxicity in Boxed Warning and also Prescribing Limits under Dosage and Administration.) AML Representative Dosage Schedule and Combination Therapy for Remission Induction IV Conventional daunorubicin hydrochloride: Adults> <60 years of age: 45 mg/m 2 IV daily on days 1, 2, and 3 of first course and on days 1 and 2 of subsequent courses, in combination with cytarabine (100 mg/m 2 IV daily for 7 days for first course and for 5 days for subsequent courses). 125 215 Conventional daunorubicin hydrochloride: Adults 60 years of age: 30 mg/m 2 IV daily on days 1, 2, and 3 of first course and on days 1 and 2 of subsequent courses, in combination with cytarabine (100 mg/m 2 IV daily for 7 days of first course and for 5 days for subsequent courses). 125 215 (Daunorubicin dosage reduction may not be appropriate if optimal supportive care is available. 215 ) Attainment of normal-appearing bone marrow may require up to 3 courses of induction therapy; evaluation of bone marrow following recovery from previous course determines whether additional course is required. 125 215 Consolidation and Cumulative Dosage Initiate appropriate consolidation therapy after induction of a complete remission. f Total dosage administered should take into account previous or concomitant therapy with other potentially cardiotoxic agents or with related drugs (e.g., doxorubicin). 125 (See Myocardial Toxicity in Boxed Warning and also Prescribing Limits under Dosage and Administration.) Advanced AIDS-related Kaposi s Sarcoma First-line Therapy IV Liposomal daunorubicin citrate: 40 mg/m 2 IV every 2 weeks. 133 Perform blood cell counts before each dose; if absolute granulocyte count> <750/mm 3 , withhold therapy until counts exceed this level. 133 Continue treatment until disease progression occurs (e.g., based on best response achieved, new visceral sites of involvement or progression of visceral disease, development of 10 new cutaneous lesions or a 25% increase in number of lesions compared with baseline, a change in character of 25% of all previously counted flat to raised lesions, increased surface area of indicator lesions) or until other complications of HIV disease preclude continuation. 133 Prescribing Limits Pediatric Patients Conventional Daunorubicin Hydrochloride IV Children> <2 years of age: Incidence of myocardial toxicity increases with total cumulative dosage> 10 mg/kg. 215 Children >2 years of age: Incidence of myocardial toxicity increases with total cumulative dosage >300 mg/m 2 . 215 Adults Conventional Daunorubicin Hydrochloride IV Incidence of myocardial toxicity increases with total cumulative dosage >400 550 mg/m 2 . 125 215 (See Cardiotoxicity under Cautions.) Special Populations Hepatic Impairment Conventional or Liposomal Daunorubicin In patients with serum bilirubin concentrations of 1.2 3 mg/dL, administer 75% of usual daily dose; in patients with serum bilirubin concentrations >3 mg/dL, administer 50% of usual dose. 125 133 215 Renal Impairment Conventional or Liposomal Daunorubicin In patients with serum creatinine concentrations >3 mg/dL, administer 50% of usual dose. 125 133 215 Cautions for daunorubicin hydrochloride Contraindications Hypersensitivity to daunorubicin or any ingredient in the formulation. 133 215 Warnings/Precautions Warnings Hematologic Effects Myelosuppression, manifested principally by severe leukopenia and thrombocytopenia, occurs in all patients receiving therapeutic dosages of conventional daunorubicin hydrochloride; infection or hemorrhage may occur. 125 Leukocyte and platelet nadirs usually occur within 10 14 days after administration, with return to normal levels during the third week. 215 f In patients with AIDS-related Kaposi s sarcoma receiving liposomal daunorubicin citrate, myelosuppression, mainly granulocytopenia (possibly severe and/or associated with fever; infection may result), is principal dose-limiting toxicity; lesser effect observed on platelets and erythroid cells. 133 164 Carefully monitor hematologic status during therapy; determine leukocyte, platelet, and erythrocyte counts prior to and at frequent intervals during therapy. 133 125 Evaluate bone marrow function to guide treatment and allow sufficient time for bone marrow recovery between courses of conventional daunorubicin. 215 f If absolute granulocyte count <750/mm 3 before scheduled dose of liposomal daunorubicin, withhold therapy until counts exceed this level. 133 Persistent, severe myelosuppression may result in superinfection or hemorrhage. 215 Severe hematologic toxicity may require supportive therapy, antibiotics for infections, and blood product transfusions. f Carefully observe patients with HIV infection and immunosuppression for intercurrent or opportunistic infections. 133 Do not initiate conventional daunorubicin in patients with preexisting drug-induced myelosuppression unless treatment benefit warrants risk. 125 215 Cardiotoxicity Risk of cardiotoxicity during or months to years after therapy; requires special attention and long-term periodic evaluation of cardiac function. 125 133 215 Preexisting cardiac disease and/or previous anthracycline (e.g., doxorubicin, epirubicin) therapy increase risk of daunorubicin-induced cardiotoxicity; carefully consider risks before initiation of therapy. 125 133 215 Infants and children appear to be at greater risk of anthracycline-induced cardiotoxicity. 125 215 Impaired left ventricular systolic performance, reduced contractility, CHF, or death reported in pediatric patients receiving anthracycline therapy; appear to be dose-dependent and aggravated by thoracic irradiation. 215 Potentially fatal CHF may occur during therapy or months to years after termination of therapy. 125 215 With conventional daunorubicin, incidence of myocardial toxicity (e.g., CHF) is increased at cumulative dosages> 550 mg/m 2 (>400 mg/m 2 in patients who have received radiation that encompassed the heart), >300 mg/m 2 in children >2 years of age, or >10 mg/kg in children <2 years of age. 125 215 With liposomal daunorubicin, CHF reported at cumulative dose of 340 mg/m 2 in at least 1 patient with AIDS-related Kaposi s sarcoma; in a limited number of patients, decreases in left ventricular ejection fraction occurred at median cumulative dose of 320 mg/m 2 (range: 200 2100 mg/m 2 ). 133 Other serious adverse cardiac effects reported with liposomal daunorubicin include pericardial effusion, pericardial tamponade, ventricular extrasystoles, cardiac arrest, sinus tachycardia, atrial fibrillation, pulmonary hypertension, MI, supraventricular tachycardia, and angina pectoris. 133 Further study and experience needed to determine relative risk of anthracycline-induced cardiotoxicity associated with liposomal versus conventional daunorubicin. 209 Previous therapy with anthracyclines (doxorubicin> 300 mg/m 2 or equivalent) may increase risk of cardiotoxicity with liposomal daunorubicin. 133 Early clinical diagnosis of drug-induced CHF and prompt initiation of treatment are essential for optimizing response to supportive therapy. 125 215 In determining total daunorubicin dose in adults and children, consider any previous or concomitant therapy with other anthracyclines (e.g., doxorubicin) or with other potentially cardiotoxic drugs. 125 Do not use daunorubicin in patients who have previously received maximum recommended cumulative dose of doxorubicin or daunorubicin. 125 215 (See Doxorubicin under Interactions.) No completely reliable method exists to predict which patients will develop drug-induced CHF. ECG and/or determination of ejection fraction recommended before each course of conventional daunorubicin; if decrease 30% in limb lead QRS voltage in ECG (associated with substantial risk of drug-induced cardiomyopathy) or decrease in systolic ejection fraction from pretreatment baseline occurs, weigh benefits against cardiac risks. 125 215 The manufacturer of liposomal daunorubicin recommends evaluation of cardiac function (e.g., history of previous cardiac disease, physical examination) before each course of therapy and determination of left ventricular ejection fraction at total cumulative doses of 320 mg/m 2 and every 160 mg/m 2 thereafter (before therapy and every 160 mg/m 2 in patients with preexisting cardiac disease and/or those who have received previous anthracycline therapy [doxorubicin >300 mg/m 2 or equivalent] or radiation that encompassed the heart). 133 Pericarditis-myocarditis, unrelated to dose, reported rarely. 125 215 Fetal/Neonatal Morbidity and Mortality May cause fetal harm. 125 133 215 Avoid pregnancy during therapy. 125 133 Because of potential benefits, use during pregnancy may be acceptable in certain conditions (e.g., life-threatening situations, severe disease for which safer drugs cannot be used or are ineffective) despite possible risks to the fetus. 125 213 214 If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard. 125 133 215 Local Effects Conventional daunorubicin hydrochloride: Extravasation during infusion may cause severe local tissue necrosis, severe cellulitis, thrombophlebitis, or painful induration; usually accompanied by immediate burning sensation at injection site. 125 215 Liposomal daunorubicin citrate: Injection site inflammation reported rarely; tissue necrosis associated with extravasation not reported to date. 133 If extravasation occurs, aspirate as much infiltrated drug as possible; f may minimize local reaction by promptly infiltrating area with hydrocortisone sodium succinate injection (50 100 mg hydrocortisone) and/or sodium bicarbonate (5 mL of 8.4% injection) and applying cold compresses. 165 206 Infusion-related Effects Liposomal daunorubicin citrate: Triad of back pain, flushing, and chest tightness reported in about 14% of patients in clinical trials; generally occurs during first 5 minutes of infusion, subsides with infusion interruption, and generally does not recur if infusion resumed at slower rate. 133 Symptoms appear to be related to lipid component since also reported with other liposomal preparations. 133 Carcinogenicity Secondary leukemias reported in patients exposed to topoisomerase II inhibitors when used concomitantly with other antineoplastic agents or radiation therapy. 125 215 Sensitivity Reactions Dermatologic Reactions Conventional daunorubicin hydrochloride: Rash, contact dermatitis, urticaria reported rarely. 215 Hypersensitivity Reactions Conventional daunorubicin hydrochloride: Anaphylactoid reactions reported rarely. 215 Liposomal daunorubicin citrate: Allergic reactions and pruritus reported. 133 General Precautions Adequate Patient Evaluation and Monitoring Administer only under the supervision of a qualified clinician experienced in the use of cancer chemotherapy agents. 133 215 Closely observe patient and frequently determine CBC; evaluate cardiac, renal, and hepatic function prior to each course of treatment. 125 133 215 Take appropriate measures to control systemic infections before beginning therapy; 125 215 however, in some patients with acute leukemia, treatment of underlying malignancy in addition to other therapy (e.g., antibiotics) may be necessary before systemic infections can be controlled. f Hyperuricemia Conventional daunorubicin hydrochloride: Possible hyperuricemia secondary to extensive purine catabolism accompanying rapid cellular destruction; monitor serum uric acid concentrations. 125 215 Minimize or prevent by administering allopurinol prior to initiation of antileukemic therapy. 125 215 Specific Populations Pregnancy Category D. 133 215 (See Fetal/Neonatal Morbidity and Mortality under Cautions.) Lactation Not known whether daunorubicin is distributed into human milk. 125 215 Discontinue nursing because of potential risk to nursing infants. 125 215 Pediatric Use Conventional daunorubicin hydrochloride: Although appropriate studies not performed, cardiotoxicity may be more frequent and occur at lower cumulative doses compared with adults. 125 215 Liposomal daunorubicin citrate: Safety and efficacy not established. 133 Geriatric Use Conventional daunorubicin hydrochloride: Although appropriate studies not performed, cardiotoxicity may be more frequent and occur at lower cumulative doses compared with younger adults. 125 215 Use with caution in patients with age-related bone marrow reserve inadequacies; consider dosage adjustment in patients with age-related renal impairment. 125 215 Liposomal daunorubicin citrate: Safety and efficacy not established. 133 Hepatic Impairment Possible enhanced toxicity; dosage adjustment recommended. 125 133 215 (See Hepatic Impairment under Dosage and Administration.) Limited clinical experience with liposomal daunorubicin citrate in patients with hepatic impairment; reduce dosage based on experience with conventional daunorubicin. 215 Renal Impairment Possible enhanced toxicity; dosage adjustment recommended. 125 133 215 (See Renal Impairment under Dosage and Administration.) Limited clinical experience with liposomal daunorubicin citrate in patients with renal impairment; reduce dosage based on experience with conventional daunorubicin. 133 Common Adverse Effects Conventional daunorubicin hydrochloride: Alopecia, nausea/vomiting, myelosuppression, mucositis. 215 Liposomal daunorubicin citrate: Myelosuppression, opportunistic infections, infusion-related effects (back pain, flushing, chest tightness), neuropathy, nausea, vomiting, alopecia, fever, fatigue. 133 Interactions for daunorubicin hydrochloride No formal drug interaction studies conducted with liposomal daunorubicin, but interactions not observed when administered concomitantly with various antiretroviral, antiviral, or anti-infective agents. 133 Myelosuppressive Agents Potential pharmacodynamic interaction (additive myelosuppressive effects); dosage reduction of daunorubicin may be required. 125 215 Hepatotoxic Agents Possible impairment of hepatic function and increased risk of toxicity. 125 215 Specific Drugs Drug Interaction Comments Cyclophosphamide Possible increased cardiotoxicity with concurrent use 125 215 Doxorubicin Increased risk of cardiotoxicity if daunorubicin used in a patient previously treated with doxorubicin 125 215 Do not use daunorubicin in patients who have previously received maximum recommended cumulative doses of doxorubicin or daunorubicin 125 215 Methotrexate Possible hepatic impairment and increased risk of toxicity 125 215 daunorubicin hydrochloride Pharmacokinetics Encapsulation in liposomes substantially alters pharmacokinetics relative to conventional IV formulations (i.e., nonencapsulated drug). 133 Absorption Bioavailability Peak plasma daunorubicin concentrations following IV administration of liposomal daunorubicin citrate are higher than those following IV administration of conventional daunorubicin hydrochloride. 164 Distribution Extent Conventional daunorubicin hydrochloride: Rapidly and widely distributed into tissues, with highest concentrations in the spleen, kidneys, liver, lungs, and heart; absorbed by cells and binds to cellular components, particularly nucleic acids. 125 215 Does not appear to cross blood-brain barrier. 125 215 Appears to cross placenta, but not known whether distributed into milk. 125 215 Liposomal daunorubicin citrate: Does not distribute into plasma and tissues as widely as conventional daunorubicin hydrochloride; decreased distribution into peripheral compartment and increased distribution into Kaposi s lesions compared with conventional IV formulation. 133 Distributes into Kaposi s sarcoma lesions to a greater extent than into healthy skin. 164 167 Appears to cross blood-brain barrier in animals; not known whether crosses blood-brain barrier in humans. 133 Plasma Protein Binding Conventional daunorubicin hydrochloride: Approximately 63% (mainly albumin). 164 Liposomal daunorubicin citrate: Minimal. 164 Elimination Metabolism Conventional daunorubicin hydrochloride: Extensively metabolized in the liver and other tissues, mainly by cytoplasmic aldoketoreductases; daunorubicinol, the major metabolite, exhibits antineoplastic activity. 125 164 Liposomal daunorubicin citrate: Daunorubicinol metabolite detected only in low concentrations in plasma after IV administration. 133 164 167 168 Elimination Route Conventional daunorubicin hydrochloride: Excreted in urine (14 25%) and bile (40%) as daunorubicin and its metabolites. 125 215 Half-life Conventional daunorubicin hydrochloride: Triphasic for daunorubicin and metabolites. f Daunorubicin elimination is biphasic: 45 minutes (initial phase) and 18.5 hours (terminal phase). 125 Daunorubicinol: terminal plasma half-life averages 26.7 hours. 125 133 164 171 Liposomal daunorubicin citrate: 4.4 hours (probably represents distribution half-life). 133 164 Special Populations Liposomal daunorubicin citrate: Pharmacokinetics not evaluated in women, in different ethnic groups, or in patients with renal or hepatic impairment. 133 Stability Storage Parenteral Powder for Injection (Conventional Daunorubicin Hydrochloride) 15 30 C. 125 Protect from light; store in carton until time of use. 125 Reconstituted solution is stable for 24 hours at room temperature and 48 hours under refrigeration; protect from exposure to sunlight. 125 Injection (Conventional Daunorubicin Hydrochloride) 2 8 C. 215 Protect from light; store in carton until time of use. 215 Prepared solution for infusion stable for 24 hours at 15 30 C; discard unused portion. 215 Liposomal Injection (Liposomal Daunorubicin Citrate) 2 8 C. 133 Protect from light; do not freeze. 133 When diluted as directed with dextrose 5% injection, solution is stable for up to 6 hours at 2 8 C. 133 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Conventional Daunorubicin Hydrochloride The manufacturers recommend that no other drugs be mixed with conventional daunorubicin hydrochloride. 215 Solution Compatibility (Conventional Daunorubicin Hydrochloride) 215 HID Compatible Dextrose 3.3% in sodium chloride 0.3% Dextrose 5% in water Ringer s injection, lactated Sodium chloride 0.9% Drug Compatibility Admixture Compatibility (Conventional Daunorubicin Hydrochloride)215fHID Compatible Cytarabine with etoposide Hydrocortisone sodium succinate Incompatible Dexamethasone sodium phosphate Heparin sodium Y-site Compatibility (Conventional Daunorubicin Hydrochloride)215HID Compatible Amifostine Anidulafungin Caspofungin acetate Etoposide phosphate Filgrastim Gemcitabine HCl Granisetron HCl Melphalan HCl Methotrexate sodium Ondansetron HCl Sodium bicarbonate Teniposide Thiotepa Vinorelbine tartrate Incompatible Allopurinol sodium Aztreonam Fludarabine phosphate Piperacillin sodium tazobactam sodium Liposomal Daunorubicin Citrate The manufacturer states that liposomal daunorubicin citrate may be mixed only with dextrose 5% injection; must not be mixed with saline, bacteriostatic agents (e.g., benzyl alcohol), or any other solution. 133 Actions Exhibits antimitotic and cytotoxic activity. 125 Intercalates into DNA and inhibits topoisomerase II (by stabilizing the complex between this enzyme and DNA), resulting in single-strand and double-strand breaks in DNA. 125 Also may inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. 215 f Also has antibacterial and immunosuppressive properties. f Advice to Patients Risk of myelosuppression; importance of informing clinicians if fever, sore throat, or unusual bleeding or bruising occurs. 215 f Risk of cardiotoxicity; advise patients of need for regular cardiac monitoring during and after therapy. 133 215 Importance of patients informing clinicians immediately if any stinging or burning at IV injection site occurs during administration. f Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy. 133 215 Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 133 215 Probable alopecia; possible transient red coloration of urine after initiation of conventional (nonencapsulated) daunorubicin hydrochloride. 125 215 Importance of informing patients of other important precautionary information. 133 215 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. DAUNOrubicin Citrate Liposomal Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection, for IV infusion 2 mg (of daunorubicin) per mL (50 mg) DaunoXome Gilead * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name DAUNOrubicin Hydrochloride Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection 20 mg (of daunorubicin) Cerubidine Bedford Injection 5 mg (of daunorubicin) per mL* DAUNOrubicin Hydrochloride Injection AHFS DI Essentials. Copyright 2017, Selected Revisions June 20, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 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