Mycamine

Mycamine Micafungin for injection

FUJISAWAEchinocandin antifungal approved for Candida infections
This novel echinocandin antifungal exerts its antibiotic activity by inhibiting the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. Micafungin was approved on March 16, 2005, for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT) and for the treatment of esophageal candidiasis.

Efficacy. The efficacy of micafungin in the treatment of esophageal candidiasis was evaluated in a randomized, double-blind study of 518 patients with endoscopically proven disease. Patients were randomized to either 150 mg/d of micafungin or 200 mg/d of intravenous fluconazole. Endoscopic cure was defined as endoscopic grade 0 on a scale of 0 to 3, and clinical cure was defined as complete resolution in clinical symptoms of esophageal candidiasis (dysphagia, odynophagia, and retrosternal pain). Overall therapeutic cure was defined as both clinical and endoscopic cure and was observed in 85.8% of micafungin-treated patients and 85.3% of fluconazole-treated patients (95% CI, –5.6 to 6.6). The efficacy of micafungin in the prophylaxis of Candida infections in HSCT patients was evaluated in a randomized, double-blind study in which patients received either 50 mg of IV micafungin qd or 400 mg IV fluconazole qd. Treatment was continued until patients experienced neutrophil recovery to an absolute neutrophil count (ANC) of ≥500 cells/mm³ or up to a maximum of 42 days after transplant (average duration of drug administration, 18 d). Successful prophylaxis was defined as the absence of a proven, probable, or suspected systemic fungal infection through the end of therapy and the absence of infection through the end of the 4-week post-therapy period. Transplant recipients who died or were lost to follow-up during the study were considered failures of prophylactic therapy. Successful prophylaxis was documented in 80.7% of recipients who received micafungin versus 73.7% of recipients who received fluconazole (95% CI, 1.5–12.5).

Dosing. The recommended dose of micafungin for the treatment of esophageal candidiasis is 150 mg/d. The recommended dose for prophylaxis of Candida infections in HSCT recipients is 50 mg/d.