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ERAXIS® (anidulafungin)

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Dosage and Administration

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

Candidemia and other Candida infections (intra-abdominal abscess, and peritonitis)

The recommended dose is a single 200 mg loading dose of ERAXIS on Day 1, followed by 100 mg daily dose thereafter. Duration of treatment should be based on the patient's clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.

Esophageal Candidiasis

The recommended dose is a single 100 mg loading dose of ERAXIS on Day 1, followed by 50 mg daily dose thereafter. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms. Duration of treatment should be based on the patient's clinical response. Because of the risk of relapse of esophageal candidiasis in patients with HIV infections, suppressive antifungal therapy may be considered after a course of treatment.

2.2 Preparation for Administration

ERAXIS for Injection must be reconstituted with sterile Water for Injection and subsequently diluted only with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline). The compatibility of reconstituted ERAXIS with intravenous substances, additives, or medications other than 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline) has not been established. The infusion solution must not be frozen.

Reconstitution 50 mg/vial

Aseptically reconstitute each 50 mg vial with 15 mL of sterile Water for Injection to provide a concentration of 3.33 mg/mL. The reconstituted solution can be stored for up to 24 hours at temperatures up to 25°C (77°F) prior to dilution into the infusion solution.

Reconstitution 100 mg/vial

Aseptically reconstitute each 100 mg vial with 30 mL of sterile Water for Injection to provide a concentration of 3.33 mg/mL. The reconstituted solution can be stored for up to 24 hours at temperatures up to 25°C (77°F) prior to dilution into the infusion solution.

2.3 Dilution and Infusion

Aseptically transfer the contents of the reconstituted vial(s) into the appropriately sized IV bag (or bottle) containing either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline). See Table 1 for the dilution and infusion instructions for each dose.

Table 1: Dilution Requirements for ERAXIS Administration
Dose Number of Vials Required Total Reconstituted Volume Required Infusion Volume* Total Infusion Volume Rate of Infusion Minimum Duration of Infusion
*
Either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline)
Infusion solution concentration is 0.77 mg/mL
50 mg 1–50 mg 15 mL 50 mL 65 mL 1.4 mL/min or 84 mL/ hour) 45 min
100 mg 2–50 mg or 1–100 mg 30 mL 100 mL 130 mL 1.4 mL/min or 84 mL/ hour) 90 min
200 mg 4–50 mg or 2–100 mg 60 mL 200 mL 260 mL 1.4 mL/min or 84 mL/ hour) 180 min

Caution: The rate of infusion should not exceed 1.1 mg/minute (equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions) [see Warnings and Precautions (5.2)].

The infusion solution may be stored for up to 48 hours at temperatures up to 25°C (77°F). Do not freeze.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or discoloration is identified, discard the solution.

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