Anidulafungin - Eraxis - Intravenous (IV) Dilution

Anidulafungin - Eraxis ™

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Usual Diluents

D5W, NS

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

(Max infusion rate: 1.1 mg/min)
Infusion solution concentration is 0.77 mg/mL
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[50 mg ] [ 50 ml ] [ 1 hour ] (Total volume: 65 ml)
   (Minimum infusion time: 45 minutes)
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[ 100 mg ] [ 100 ml ] [ 2 hours ] (Total volume: 130 ml)
   (Minimum infusion time: 90 minutes)
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[ 200 mg ] [ 200 ml ] [ 4 hours ] (Total volume: 260 ml)
   (Minimum infusion time: 180 minutes)

Stability / Miscellaneous

Reconstitution

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 2°C – 8°C (36°F – 46°F) 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 2°C – 8°C (36°F – 46°F) 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 below for the dilution and infusion instructions for each dose.

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

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 2°C – 8°C (36°F – 46°F). 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.

DOSAGE AND ADMINISTRATION
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.

HOW SUPPLIED
ERAXIS (anidulafungin) for Injection is supplied in a single-use vial of sterile, lyophilized, preservative-free, powder. ERAXIS (anidulafungin) is available in the following packaging configuration:

Single Use Vial of ERAXIS 50 mg
NDC 0049-0114-28 One - 50 mg vial

Single Use Vial of ERAXIS 100 mg)
NDC 0049-0116-28 One - 100 mg vial

STORAGE
Unreconstituted vials
ERAXIS unreconstituted vials should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F). Do not freeze.

Reconstituted solution
ERAXIS reconstituted solution can be stored in a refrigerator at 2°C – 8°C (36°F – 46°F) for up to one hour. Do not freeze.

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 1 hour at 5°C (41°F). .

Infusion solution
ERAXIS infusion solution can be stored in a refrigerator at 2°C – 8°C (36°F – 46°F ), but should be administered within 24 hours. Do not freeze.

Chemical and physical in-use stability of the infusion solution has been demonstrated for 24 hours at 5°C (41°F).

The rate of infusion should not exceed 1.1 mg/minute.

Source: Eraxis [package insert]. New York, NY: Pfizer inc, 2007