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Microbiology

Mechanism of Action
Micafungin inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls, which is not present in mammalian cells.

Activity In Vitro
Micafungin exhibited in-vitro activity against C. albicans, C. glabrata, C. guilliermondii, C. krusei, C. parapsilosis and C. tropicalis. Standardized susceptibility testing methods for 1,3-β-D-glucan synthesis inhibitors have recently been proposed by the CLSI, however, the correlation between the results of susceptibility studies and clinical outcome has not been established.

Activity In Vivo
Micafungin sodium has shown activity in both mucosal and disseminated murine models of candidiasis. Micafungin sodium, administered to immunosuppressed mice in models of disseminated candidiasis prolonged survival and/or decreased the mycological burden.

Drug Resistance
Mutants of Candida with reduced susceptibility to micafungin have been identified in some patients during treatment suggesting a potential for development of drug resistance. The incidence of drug resistance by various clinical isolates of Candida species is unknown.

Indications

Mycamine® is indicated for:

1.1 Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses.
Mycamine has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections.

1.2 Treatment of Patients with Esophageal Candidiasis.

1.3 Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation.

NOTE: The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.

Dosage and administration

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.

Mycamine Dosage
Indication Recommended Reconstituted Dose Once Daily
 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 10-47 days).

† 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 dysfunction or mild-to-moderate hepatic insufficiency. The effect of severe hepatic impairment on micafungin pharmacokinetics has not been studied.

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.

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

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