"The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.
Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) cau"...
ERAXIS is indicated for use in adults for the treatment of the following fungal infections listed below. Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies known. However, once these results become available, antifungal therapy should be adjusted accordingly.
Candidemia and Other Forms of Candida Infections (Intra-abdominal Abscess and Peritonitis)
ERAXIS is indicated for the treatment of esophageal candidiasis [see Clinical Studies, Table 10 for higher relapse rates off ERAXIS therapy].
Limitation of Use
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.
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.
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.
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.
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 Volumea||Total Infusion Volumeb||Rate of Infusion||Minimum Duration of Infusion|
|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|
|aEither 5% Dextrose Injection, USP or 0.9% Sodium Chloride
Injection, USP (normal saline)
bInfusion solution concentration is 0.77 mg/mL
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].
The infusion solution may be stored for up to 48 hours at temperatures up to 25°C (77°F), or stored frozen for at least 72 hours prior to administration.
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 Forms And Strengths
Lyophilized powder for injection: 50 mg per vial Lyophilized powder for injection: 100 mg per vial
Storage And Handling
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
ERAXIS unreconstituted vials should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F). Do not freeze.
Excursions for 96 hours up to 25°C (77°F) are permitted, and the vial can be returned to storage at 2°C – 8°C (36°F – 46°F).
ERAXIS reconstituted solution can be stored at up to 25°C (77°F) for up to 24 hours.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C (77°F).
From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilized for up to 24 hours when stored at 25°C.
ERAXIS infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours or stored frozen for at least 72 hours.
Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25°C (77°F) or 72 hours when stored frozen.
From a microbiological point of view, following good aseptic practices, the infusion solution can be utilized for up to 48 hours from preparation when stored at 25°C.
Distributed by: Roerig, Division of Pfizer Inc, NY, NY 10017. Revised: 07/2012
Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Eraxis Information
Report Problems to the Food and Drug Administration
Find out what women really need.