Micafungin Sodium (4 brand names, 3 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, POWDER, SOLUTION.
Routes of administration: INTRAVENOUS, INJECTION.
Brand Names
- MICAFUNGIN
- MICAFUNGIN IN SODIUM CHLORIDE 0.9%
- MICAFUNGIN SODIUM
- MYCAMINE
Related Health Topics
Indications and Usage
MYCAMINE® is indicated for: • 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)]. • 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)] . • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [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 [see Clinical Studies (14.3)] . Limitations of Use • 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)] . • MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida. • The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.
Contraindications
MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin, any component of MYCAMINE, or other echinocandins.
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: •Hypersensitivity Reactions [see Warnings and Precautions (5.1)] •Hematological Effects [see Warnings and Precautions (5.2)] •Hepatic Effects [see Warnings and Precautions (5.3)] •Renal Effects [see Warnings and Precautions (5.4)] •Infusion and Injection Site Reactions [see Warnings and Precautions (5.5)]
Mechanism of Action
Micafungin is a member of the echinocandin class of antifungal agents [see Microbiology (12.4)].
Overdosage
MYCAMINE is highly protein bound and, therefore, is not dialyzable. No cases of MYCAMINE overdosage have been reported. Repeated daily doses up to 8 mg/kg (maximum total dose of 896 mg) in adult patients, up to 6 mg/kg in pediatric patients 4 months of age and older, and up to 15 mg/kg in pediatric patients younger than 4 months of age have been administered in clinical trials with no reported dose-limiting toxicity [see Adverse Reactions (6.1) and Use in Specific Populations (8.4)].