What is the generic name?

MICAFUNGIN SODIUM

What is the Trade Name for MICAFUNGIN SODIUM?

Mycamine

What are the Indications for MICAFUNGIN SODIUM?

• 1 INDICATIONS AND USAGE MYCAMINE ¬Æ is indicated for: ‚Ä¢ Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.1 ) and Use in Specific Populations ( 8.4 )] . ‚Ä¢ 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 [see Use in Specific Populations ( 8.4 )] . ‚Ä¢ Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.2 )] . ‚Ä¢ Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies ( 14.3 )] . Limitations of Use ‚Ä¢ The safety and effectiveness of MYCAMINE 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 )] . ‚Ä¢ MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida . ‚Ä¢ The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established. MYCAMINE ¬Æ is an echinocandin indicated in adult and pediatric patients for ( 1 ): ‚Ä¢ Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older. ‚Ä¢ 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. ‚Ä¢ Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older. ‚Ä¢ Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT). Limitations of Use ‚Ä¢ The safety and effectiveness of MYCAMINE 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 , 2.3 , 8.4 ) ‚Ä¢ MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida. ( 1 ) ‚Ä¢ The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established. ( 1 )

References: https://open.fda.gov/