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DAW-no-RUE-bih-sin SIH-trate
DaunoXome
Solution for injection
equivalent to 2 mg/mL daunorubicin base; 25 mL single-use vials.
Class: Antineoplastic
Anthracycline antibiotic

 Actions Anthracycline antibiotic formulated to increase selectivity for solid tumors in situ. The elimination half-life is 4.4 hr. Daunorubicinol is the major active metabolite of daunorubicin.

 Indications

Adult

Advanced HIV-associated Kaposi’s sarcoma.

Pediatric

Not approved; safety and efficacy not established.

 Contraindications None well documented.

 Route/Dosage

Advanced HIV-Associated Kaposi’s Sarcoma

ADULTS: IV 40 mg/m2/dose (of daunorubicin base) administered over 1 hr q 2 wk. Note: The dose of daunorubicin citrate liposomal is different from the dose of daunorubicin hydrochloride.

Dosage Adjustment for Renal or Hepatic Function

If serum bilirubin is 1.2 to 3 mg/dL, then give 75% of adjusted dose from prior course. If serum bilirubin > 3 mg/dL or serum creatinine > 3 mg/dL, then give 50% of adjusted dose from prior course.

Interactions None well documented.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Cardiomyopathy; cardiotoxicity; edema; chest pain. CNS: Depression; dizziness; fatigue; headache; insomnia; malaise; neuropathy. DERMATOLOGIC: Alopecia; pruritus. GI: Nausea; vomiting; diarrhea; abdominal pain; anorexia; stomatitis; constipation. GU: Reddish-colored urin. HEMATOLOGIC: Myelosuppression; neutropenia. HYPERSENSITIVITY: Back pain; flushing; chest tightness. MUSCULOSKELETAL: Arthralgia; back pain; myalgia; rigors. RESPIRATORY: Cough; dyspnea; rhinitis; sinusitis.

 Precautions

Pregnancy: Category D. Daunorubicin dose: The dose of daunorubicin citrate liposomal is different from the dose of daunorubicin hydrochloride. Decreased LVEF: Anthracycline-induced cardiomyopathy is associated with decreased LVEF. Extravasation risk: Local irritation of phelebitis may occur. Refer to your institution specific protocol. Hepatic and renal function: Assess hepatic and renal function before initiating therapy; adjust dose as necessary. Reduce dosage for hepatic or renal function impairment. Myelosuppression: The primary toxicity of daunorubicin is myelosuppression, especially of the granulocytic series, which may be severe, with much less marked effects on the platelets and erythroid series.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Administer by IV infusion over 60 min.
  • Follow procedures for proper handling and disposal of anticancer drugs. Wear gloves and avoid skin exposure and inhalation of fumes.
  • Store vials in refrigerator and protect from light.
  • Dilute 1:1 with 5% Dextrose to a final daunorubicin concentration of 1 mg/mL. Do not use an in-line filter for IV infusion.
  • The diluted 1 mg/mL solution can be refrigerated for a maximum of 6 hr at 2° to 8°C (36° to 46°F). Do not freeze. Protect from light.

 Assessment/Interventions

  • The lipid component of daunorubicin citrate is associated with infusion reactions, which may occur within the first 5 min of starting the infusion and manifest as back pain, flushing, and chest tightness. The reaction may be controlled by temporarily stopping the infusion and reinitiating the infusion at a slower rate.
  • Daunorubicin citrate liposomal is an irritant and can cause local irritation or phlebitis.
  • Evaluate LVEF when the patient has received a cumulative total daunorubicin dose of 320 mg/m2, 480 mg/m2, and every 160 mg/m2 thereafter.
  • Monitor chemical and laboratory tests extensively. Evaluate cardiac, renal, and hepatic function prior to each course of treatment. Withold if the absolute granulocyte count is < 750 cells/mm3. Monitor serum uric acid levels.
  • Administer allopurinol prior to initiating antileukemic therapy as a precaution against hyperuricemia.
  • Control any systemic infections before beginning therapy.
OVERDOSAGE: SIGNS & SYMPTOMS
  Symptoms of acute overdosage are increaed severities of the observed dose-limiting toxicities of therapeutic doses, myelosuppression (especially granulocytopenia), fatigue, nausea, vomiting.

 Patient/Family Education

  • Daunorubicin citrate may cause transient red discoloration of urine; counsel patients to expect this effect.

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