Mycamine (Micafungin Sodium) - Summary

MYCAMINE SUMMARY

Mycamine®
(micafungin sodium) For Injection

MYCAMINE is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1, 3-β-D-glucan, an integral component of the fungal cell wall. Each single-use vial contains 50 mg micafungin sodium, 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). MYCAMINE must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP (see DOSAGE AND ADMINISTRATION). Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5.0-7.0.

MYCAMINE is indicated for:

• Treatment of patients with esophageal candidiasis (see CLINICAL STUDIES, MICROBIOLOGY)
• Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation (see CLINICAL STUDIES, MICROBIOLOGY).

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

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NEWS HIGHLIGHTS

Published Studies Related to Mycamine (Micafungin)

Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial. [2008.09]
BACKGROUND: Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, and pediatric data on available antifungal therapies are lacking... CONCLUSIONS: Micafungin seems to be similarly effective and as safe as liposomal amphotericin B for the treatment of invasive candidiasis in pediatric patients. (ClinicalTrials.gov number, NCT00106288).

Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. [2007.10.01]
BACKGROUND: Invasive candidiasis is an important cause of morbidity and mortality among patients with health care-associated infection. The echinocandins have potent fungicidal activity against most Candida species, but there are few data comparing the safety and efficacy of echinocandins in the treatment of invasive candidiasis... CONCLUSIONS: Dosages of micafungin 100 mg daily and 150 mg daily were noninferior to a standard dosage of caspofungin for the treatment of candidemia and other forms of invasive candidiasis.

Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. [2007.05.05]
BACKGROUND: Invasive candidosis is increasingly prevalent in seriously ill patients. Our aim was to compare micafungin with liposomal amphotericin B for the treatment of adult patients with candidaemia or invasive candidosis... INTERPRETATION: Micafungin was as effective as--and caused fewer adverse events than--liposomal amphotericin B as first-line treatment of candidaemia and invasive candidosis.

Steady-state pharmacokinetics of micafungin and voriconazole after separate and concomitant dosing in healthy adults. [2007.02]
We assessed the pharmacokinetics and interactions of steady-state micafungin (Mycamine) or placebo with steady-state voriconazole in 35 volunteers. The 90% confidence intervals around the least-squares mean ratios for micafungin pharmacokinetic parameters and placebo-corrected voriconazole pharmacokinetic parameters were within the 80%-to-125% limits, indicating an absence of drug interaction..

International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia. [2005.10]
Candida spp... Large-scale, randomized, controlled trials are warranted.

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Clinical Trials Related to Mycamine (Micafungin)

Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU [Terminated]

Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis [Terminated]
The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.

Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia [Completed]
The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.

Study of Micafungin in Patients With Invasive Candidiasis or Candidemia [Completed]
The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis [Completed]

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