Stability data:
|
| Drug |
Stability
Refrigerated |
Stability
Room Temp. |
Reconstituted
Vial/Powder |
Notes |
| Anidulafungin - Eraxis |
Unreconstituted vials
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 25ºC (77ºF) are permitted, and the vial can be returned to storage at 2°C – 8°C (36°F – 46°F). |
Reconstituted solution
ERAXIS reconstituted solution can be stored at up to 25°C (77°F) for up to 24 hours. |
Powder |
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. |
Reconstitution
Preparation of ERAXIS 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 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 package insert for Warnings and Precautions (5.2)].
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.
INDICATIONS AND USAGE
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 candidemia and the following Candida infections: intra-abdominal abscess and peritonitis.
Esophageal Candidiasis
ERAXIS is indicated for the treatment of esophageal candidiasis.
Limitation of Use
ERAXIS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida, and has not been studied in sufficient numbers of neutropenic patients to determine efficacy in this group.
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.
Microbiology
Mechanism of Action
Anidulafungin is a semi-synthetic echinocandin with antifungal activity. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-ß-D-glucan, an essential component of the fungal cell wall.
Activity in vitro
Anidulafungin has been shown to be active against Candida albicans, C. glabrata, C. parapsilosis, and C. tropicalis both in vitro and in clinical infections as described in INDICATIONS AND USAGE and CLINICAL STUDIES. Because of the potential for reduced susceptibility to anidulafungin, it is recommended that susceptibility be determined by a standardized method.
Anidulafungin minimal inhibitory concentrations (MICs) were determined for isolates of Candida spp. obtained during clinical studies using a standardized method. However, no correlation between in vitro activity as determined by this method and clinical outcome was established.
Drug Resistance
Echinocandin resistance is due to point mutations within the genes (FKS1 and FKS2) encoding for subunits in the glucan synthase enzyme complex. There have been reports of Candida isolates with reduced susceptibility to anidulafungin, suggesting a potential for development of drug resistance. The clinical significance of this observation is not fully understood.
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.
Excursions for 96 hours up to 25ºC (77ºF) are permitted, and the vial can be returned to storage at 2°C - 8°C (36°F - 46°F).
Reconstituted solution
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 25ºC (77ºF).
From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilized for up to 24 hours when stored at 25ºC.
Infusion Solution
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 25ºC (77ºF) 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 25ºC.
The rate of infusion should not exceed 1.1 mg/minute.
Source: Eraxis [package insert]. New York, NY: Pfizer inc, 2013 |
