Abelcet (Amphotericin B) - Indications and Dosage

INDICATIONS AND USAGE

ABELCET^® indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES).

DOSAGE AND ADMINISTRATION

The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. ABELCET^® should be administered by intravenous infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.

Renal toxicity of ABELCET^®, as measured by serum creatinine levels, has been shown to be dose dependent. Decisions about dose adjustments should be made only after taking into account the overall clinical condition of the patient.

Preparation of Admixture for Infusion:    Shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose of ABELCET^® from the required number of vials into one or more sterile syringes using an 18-gauge needle. Remove the needle from each syringe filled with ABELCET^® and replace with the 5-micron filter needle supplied with each vial. Each filter needle may be used to filter the contents of up to four 100 mg vials. Insert the filter needle of the syringe into an IV bag containing 5% Dextrose Injection USP, and empty the contents of the syringe into the bag. The final infusion concentration should be 1 mg/mL. For pediatric patients and patients with cardiovascular disease the drug may be diluted with 5% Dextrose Injection to a final infusion concentration of 2 mg/mL. Before infusion, shake the bag until the contents are thoroughly mixed. Do not use the admixture after dilution with 5% Dextrose Injection if there is any evidence of foreign matter. Vials are for single use. Unused material should be discarded. Aseptic technique must be strictly observed throughout handling of ABELCET^®, since no bacteriostatic agent or preservative is present.

DO NOT DILUTE WITH SALINE SOLUTIONS OR MIX WITH OTHER DRUGS OR ELECTROLYTES as the compatibility of ABELCET^® with these materials has not been established. An existing intravenous line should be flushed with 5% Dextrose Injection before infusion of ABELCET^®, or a separate infusion line should be used. DO NOT USE AN IN-LINE FILTER.

The diluted ready-for-use admixture is stable for up to 48 hours at 2° to 8°C (36° to 46°F) and additional 6 hours at room temperature.

HOW SUPPLIED

Single-use vials along with 5-micron filter needles are individually packaged.

100 mg of ABELCET^® in 20 mL of suspension NDC 57665-101-41

STORAGE

Prior to admixture, ABELCET^® should be stored at 2° to 8°C (36° to 46°F) and protected from exposure to light. Do not freeze. ABELCET^® should be retained in the carton until time of use.

The admixed ABELCET^® and 5% Dextrose Injection may be stored for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature. Do not freeze. Any unused material should be discarded.

U.S. Patent Nos. 4,973,465      5,616,334                         11/02

                                                   I-101-41-US-K

ENZON Pharmaceuticals

Distributed by: ENZON Pharmaceuticals, Piscataway, NJ 08854

ABELCET^® is a registered trademark of ENZON Pharmaceuticals.