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.
No dosing adjustments are required for patients with any degree of renal or hepatic
insufficiency, patients using concomitant medications or those in other special
populations (see CLINICAL PHARMACOLOGY – Special Populations and Drug Interaction
Studies).
Preparation of ERAXIS for Administration
ERAXIS for Injection must be reconstituted with sterile Water for Injection and subsequently diluted with only 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.
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 in a refrigerator for up to one hour at 2ºC – 8ºC (36ºF – 46ºF) prior to dilution into the infusion solution. Do not freeze.
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 in a refrigerator for up to one hour at 2ºC – 8ºC (36ºF – 46ºF) prior to dilution into the infusion solution. Do not freeze.
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 10 for the
dilution and infusion instructions for each dose.
Table 10. Dilution Requirements for ERAXIS Administration
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).
If the infusion solution is not used immediately, it should be stored in a refrigerator at 2ºC – 8ºC (36ºF – 46ºF). Do not freeze. The infusion solution should be administered within 24 hours of preparation.
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.