daunorubicin (Rx)Brand and Other Names:Cerubidine

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 5mg/mL

powder for injection

  • 20mg
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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
more...

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

daunorubicin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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%

            Arrythmia

            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

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            Formulary

            FormularyPatient Discounts

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            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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