DAUNOXOME Concentrate for solution for infusion Ref.[2720] Active ingredients: Daunorubicin

DaunoXome should be administered by intravenous infusion. The recommended initial dose of DaunoXome in patients with AIDS-related Kaposi’s sarcoma is 40 mg/m² every two weeks. The dosage of DaunoXome must be adjusted for each patient. Therapy should be continued as long as disease control can be maintained.

DaunoXome should be diluted with 5% dextrose for infusion before administration. The recommended concentration after dilution is between 0.2 mg and 1 mg daunorubicin/ml of solution. DaunoXome should be administered intravenously over a minimum period of 30-60 minutes (see also Sections 6.2, 6.3 and 6.6.).

DaunoXome must not be given by the intramuscular or subcutaneous route or as a bolus injection.

DaunoXome is a liposomal preparation and should not be used interchangeably with conventional daunorubicin.

Pediatric patients

DaunoXome is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.

Elderly

The safety and effectiveness of DaunoXome in patients over 65 years of age have not been established. Cardiotoxicity may be more frequent in the elderly (see Section 4.4).

Hepatic impairment and renal impairment

DaunoXome has not been studied in patients with impaired liver or renal function, therefore DaunoXome is not recommended in such situations.

From experience with non-liposomal anthracyclin preparations, the primary anticipated toxicity from such an overdose would be myelosuppression. Furthermore other side effects may occur in more pronounced form, like cardiomyopathy. In the event of overdose bone marrow function and cardiac function should be carefully monitored with appropriate therapy for any severe side-effects.

Shelf life: The shelf life is 12 months when stored at 2-8ºC.

Chemical and physical in-use stability has been demonstrated for DaunoXome diluted with 5% dextrose, see table below for details.

From a microbial point of view, diluted DaunoXome should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2-8ºC for the 5% dextrose dilutions. This recommendation is made on the assumption that dilution has taken place in controlled and validated aseptic conditions.

Store concentrate in a refrigerator (at 2-8ºC). Do not freeze. Keep the vial in the outer carton in order to protect from light.

DaunoXome is presented in 50-ml sterile Type 1glass Ph. Eur. vial. Each vial contains 25 ml liquid for infusion. The closure consists of a butyl rubber stopper and aluminum ring seal fitted with a removable plastic cap. Each single-dose vial is packed in a white chipboard carton. Included in each carton are directions for use.

Pack size 1 × 25 mL.

Do not store partially used vials for future patient use. Vials are for single use only. Discard any unused product. Visually examine the vial for evidence of deterioration. Evidence of deterioration include precipitation or crystals forming in the product, change in color from other than a translucent red color. If the vial shows evidence of damage including leakage or deterioration, do not use the product and discard product in a manner consistent with the handling of anti-cancer drugs.

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

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 into a sterile syringe. Instil the DaunoXome preparation into a sterile container with the correct amount of 5% dextrose for infusion. The recommended concentration after dilution is between 0.2 mg and 1 mg daunorubicin/ml of solution. Infuse over a 30-60 minute period. As with all parenteral drug products, inspect the solution visually for particulate matter prior to administration.

Caution: The only fluid which may be mixed with DaunoXome 5% dextrose for infusion; DaunoXome should not be mixed with saline, bacteriostatic agents such as benzyl alcohol, or any other solution.

An in-line filter is not recommended for the intravenous infusion of DaunoXome. However, if such a filter is used, the mean pore diameter of the filter should not be less than 5 micron.

If DaunoXome comes in contact with skin or cornea, wash immediately with copious amounts of cold water. The patient should seek medical attention if signs of inflammation should occur.

DaunoXome should be handled, and any remainder should be disposed of in a manner consistent with the handling of anti-cancer drugs. Any unused product or waste material should be disposed of in accordance with local requirements.