Anidulafunginum

Before starting therapy, material for culture and other laboratory tests (including histological examination) should be obtained to isolate and identify the causative agent. Treatment can be started until laboratory results are obtained. However, once these results are obtained, antifungal therapy should be adjusted.

The drug Anidulafungin is administered intravenously.

The infusion rate should not exceed 1.1 mg/min, which is equivalent to 1.4 ml/min or 84 ml/hour for a 100 mg dosage.

The minimum duration of infusion is 90 min.

Adult patients

For information for patients with rare hereditary fructose intolerance, see Special Instructions.

Invasive candidiasis, including candidemia

On the first day the preparation Anidulafungin is administered once in a dose of 200 mg, further in a dose of 100 mg/day. Duration of treatment depends on the clinical response of the patient. Antifungal therapy should be continued for at least 14 days after the disappearance of symptoms of infection and eradication of the pathogen.

Oesophageal candidiasis

On the first day the drug Anidulafungin is administered once in a dose of 100 mg, further in a dose of 50 mg/day. Duration of treatment depends on the clinical response of the patient and is at least 14 days, and at least 7 days after disappearance of symptoms of infection. At the risk of recurrence of oesophageal candidiasis in patients with HIV infection, the need for antifungal therapy after treatment with Anidulafungin should be determined.

Children (1 month of age and older)

For information for patients with rare hereditary fructose intolerance and for all paediatric patients less than 2 years of age, see Special Instructions.

Invasive candidiasis, including candidemia

On the first day Anidulafungin is administered once at a dose of 3.0 mg/kg (not exceeding the dose of 200 mg), then at a dose of 1.5 mg/kg/day (not exceeding the dose of 100 mg). The duration of antifungal therapy is usually at least 14 days after the last negative culture result (defined as the second of two consecutive negative cultures separated by an interval of at least 24 hours after the last positive culture) and after the disappearance of clinical signs and symptoms of invasive candidiasis, including candidemia. Switching to oral administration of antifungal drug is possible after intravenous therapy with anidulafungin for at least 10 days. The efficacy and safety of anidulafungin has not been established in newborn children (under 1 month of age) (see section "Special instructions").

Instructions for preparation of the solution

The drug Anidulafungin is available in vials for single use. Anidulafungin preparation should be reconstituted with water for injection and then diluted ONLY with 0.9% sodium chloride solution for infusion or 5% dextrose solution for infusion.

WARNING: The compatibility of reconstituted anidulafungin with other intravenous preparations, as well as with solutions, is unknown.

Reconstitution

Under aseptic conditions, 30 ml of water for injection is added to the vial and a solution containing anidulafungin at a concentration of about 3.33 mg/ml is obtained. Reconstitution may take about 5 minutes.

The reconstituted solution can be stored at 25 °C for 24 hours.

Dilution and infusion

Medicinal products for parenteral administration should be checked visually for visible particles and visible staining of the solution before administration, if the solution and container permit. If visible particles or visible staining are found, the solution should be destroyed.

Adult patients

Under aseptic conditions, the reconstituted solution is transferred from the vial to an infusion bag (or vial) containing 0.9% sodium chloride solution for infusion or 5% dextrose solution for infusion to achieve the required concentration of anidulafungin. The table below summarises the method of dilution to a concentration of 0.77 mg/ml for the final solution for infusion and instructions for preparing the infusion solution.

The final solution for infusion should be stored at 25 °C and used within 48 hours.