Micafungin in Sodium Chloride

1 INDICATIONS AND USAGE Micafungin in Sodium Chloride Injection is indicated for: • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [ see Clinical Studies (14.1) and Use in Specific Populations (8.4) ]. • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [ see Use in Specific Populations (8.4) ]. • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [ see Clinical Studies (14.2) ]. • Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved [ see Clinical Studies (14.3) ]. Limitations of Use • The safety and effectiveness of Micafungin in Sodium Chloride Injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [ see Use in Specific Populations (8.4) ]. • Micafungin in Sodium Chloride Injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida. • The efficacy of Micafungin in Sodium Chloride Injection against infections caused by fungi other than Candida has not been established. Micafungin in Sodium Chloride Injection is an echinocandin indicated in adult and pediatric patients for ( 1 ): • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved. • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved. • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved. • Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT) for whom appropriate dosing with this formulation can be achieved. Limitations of Use • The safety and effectiveness of Micafungin in Sodium Chloride Injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed. ( 1 , 2.4 , 8.4 ) • Micafungin in Sodium Chloride Injection has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida. ( 1 ) • The efficacy of Micafungin in Sodium Chloride Injection against infections caused by fungi other than Candida has not been established. ( 1 )