Daunorubicin Citrate Liposomal

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.

 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.

 Patient/Family Education

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