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Daunoxome (Daunorubicin Citrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

DaunoXome is indicated as a first line cytotoxic therapy for advanced HIV-associated Kaposi's sarcoma. DaunoXome is not recommended in patients with less than advanced HIV-related Kaposi's sarcoma.

DOSAGE AND ADMINISTRATION

DaunoXome should be administered intravenously over a 60 minute period at a dose of 40 mg/m2, with doses repeated every two weeks. Blood counts should be repeated prior to each dose, and therapy withheld if the absolute granulocyte count is less than 750 cells/mm3. Treatment should be continued until there is evidence of progressive disease (e.g., based on best response achieved: new visceral sites of involvement, or progression of visceral disease; development of 10 or more new, cutaneous lesions or a 25% increase in the number of lesions compared to baseline; a change in the character of 25% or more of all previously counted flat lesions to raised; increase in surface area of the indicator lesions), or until other intercurrent complications of HIV disease preclude continuation of therapy.

Patients with Impaired Hepatic and Renal Function

Limited clinical experience exists in treating hepatically and renally impaired patients with DaunoXome.

Therefore, based on experience with daunorubicin HCl, it is recommended that the dosage of DaunoXome be reduced if the bilirubin or creatinine is elevated as follows: Serum bilirubin 1.2 to 3 mg/dL, give ¾ the normal dose; serum bilirubin or creatinine > 3 mg/dL, give ½ the normal dose.
Do not mix DaunoXome with other drugs.

Preparation Of Solution

DaunoXome should be diluted 1:1 with 5% Dextrose Injection (D5W) before administration. Each vial of DaunoXome contains daunorubicin citrate equivalent to 50 mg daunorubicin base, at a concentration of 2 mg/mL. The recommended concentration after dilution is 1 mg daunorubicin/mL of solution.

Use aseptic technique.

Aseptic technique must be strictly observed in all handling, since no preservative or bacteriostatic agent is present in DaunoXome or in the materials recommended for dilution.

Withdraw the calculated volume of DaunoXome from the vial into a sterile syringe, and transfer it into a sterile infusion bag containing an equivalent amount of D5W. Administer diluted DaunoXome immediately. If not used immediately, diluted DaunoXome should be refrigerated at 2°– 8 °C (36°– 46°F) for a maximum of 6 hours.

Caution: The only fluid which may be mixed with DaunoXome is D5W; DaunoXome must not be mixed with saline, bacteriostatic agents such as benzyl alcohol, or any other solution.

Do not use an in-line filter for the intravenous infusion of DaunoXome.

All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DaunoXome is a translucent dispersion of liposomes that scatters light to some degree. Do not use DaunoXome if it appears opaque, or has precipitate or foreign matter present.

Procedures for proper handling and disposal of anticancer drugs should be followed.1–8

HOW SUPPLIED

DaunoXome is a translucent, red, liposomal dispersion supplied in single use vials, each sealed with a synthetic rubber stopper and aluminum sealing ring with a plastic cap. DaunoXome provides daunorubicin citrate equivalent to 50 mg of daunorubicin base, at a concentration of 2 mg/mL.

DaunoXome is supplied under NDC 10885-001-01 for a single unit pack.

Storage

Store DaunoXome in a refrigerator, 2°–8°C (36°–46°F). Do not freeze. Protect from light.

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