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Mycamine® is indicated for:
Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses
[see Clinical Studies].
Treatment of Patients with Esophageal Candidiasis
[see Clinical Studies].
Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation
[see Clinical Studies].
NOTE: The efficacy of Mycamine against infections caused by fungi other than Candida has not been established.
DOSAGE AND ADMINISTRATION
Do not mix or co-infuse Mycamine with other medications. Mycamine has been shown to precipitate when mixed directly with a number of other commonly used medications.
Table 1. Mycamine Dosage
|Indication|| Recommended Reconstituted Dose
|Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses*||100 mg|
|Treatment of Esophageal Candidiasis†||150 mg|
|Prophylaxis of Candida Infections in HSCT Recipients‡||50 mg|
|* In patients treated successfully for candidemia and other
Candida infections, the mean duration of treatment was 15 days (range
† In patients treated successfully for esophageal Candidiasis, the mean duration of treatment was 15 days (range 10-30 days).
‡In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6-51 days).
A loading dose is not required. Typically, 85% of the steady-state concentration is achieved after three daily Mycamine doses.
No dosing adjustments are required based on race, gender, or in patients with severe renal impairment or in patients with mild, moderate, or severe hepatic impairment, [see Use In Specific Populations].
No dose adjustment for Mycamine is required with concomitant use of mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, voriconazole, itraconazole, amphotericin B, ritonavir, or rifampin. [see DRUG INTERACTIONS].
Directions for Reconstitution and Dilution
Please read this entire section carefully before beginning reconstitution.
The diluent to be used for reconstitution and dilution is 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent). Alternatively, 5% Dextrose Injection, USP, may be used for reconstitution and dilution of Mycamine. Solutions for infusion are prepared as follows:
Mycamine 50 mg vial
Aseptically add 5 mL of 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent) to each 50 mg vial to yield a preparation containing approximately 10 mg micafungin/mL.
Mycamine 100 mg vial
Aseptically add 5 mL of 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent) to each 100 mg vial to yield a preparation containing approximately 20 mg micafungin/mL.
As with all parenteral drug products, reconstituted Mycamine should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use material if there is any evidence of precipitation or foreign matter. Aseptic technique must be strictly observed in all handling since no preservative or bacteriostatic agent is present in Mycamine or in the materials specified for reconstitution and dilution.
To minimize excessive foaming, GENTLY dissolve the Mycamine powder by swirling the vial. DO NOT VIGOROUSLY SHAKE THE VIAL. Visually inspect the vial for particulate matter.
The diluted solution should be protected from light. It is not necessary to cover the infusion drip chamber or the tubing.
- For treatment of candidemia. acute disseminated candidiasis, Candida peritonitis and abscesses: add 100 mg of reconstituted Mycamine into 100 mL of 0.9% Sodium Chloride Injection, USP or 100 mL of 5% Dextrose Injection, USP.
- For treatment of esophageal candidiasis: add 150 mg of reconstituted Mycamine into 100 mL of 0.9% Sodium Chloride Injection, USP or 100 mL of 5% Dextrose Injection, USP.
- For prophylaxis of Candida infections: add 50 mg of reconstituted Mycamine into 100 mL of 0.9% Sodium Chloride Injection, USP or 100 mL of 5% Dextrose Injection, USP.
Mycamine is preservative-free. Discard partially used vials.
Infusion Volume and Duration
Mycamine should be administered by intravenous infusion only. Infuse over one hour. More rapid infusions may result in more frequent histamine mediated reactions.
An existing intravenous line should be flushed with 0.9% Sodium Chloride Injection, USP, prior to infusion of Mycamine.
Dosage Forms and Strengths
50 mg and 100 mg single-use vials
Mycamine is available in:
- cartons of 10 individually packaged 50 mg single-use vials, coated with a light protective film and sealed with a blue flip-off cap. (NDC 0469-3250-10).
- cartons of 10 individually packaged 100 mg single-use vials, coated with a light protective film and sealed with a red flip-off cap. (NDC 0469-3211-10)
Unopened vials of lyophilized material must be stored at room temperature, 25° C (77° F);
excursions permitted to 15°-30°C (59°-86°F). [see USP Controlled Room Temperature.]
The reconstituted product may be stored in the original vial for up to 24 hours at room temperature, 25° C (77° F).
The diluted infusion should be protected from light and may be stored for up to 24 hours at room temperature, 25° C (77° F).
Made in Japan Marketed by: Astellas Pharma US, Inc. Deerfield, IL 60015-2548. Revised: June 2011
Last reviewed on RxList: 7/18/2011
This monograph has been modified to include the generic and brand name in many instances.
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