Micafungin

What it is used for

Micafungin for 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.
• 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.
• Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
• Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation.

Limitations of Use

• The safety and effectiveness of micafungin for 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.
• Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.
• The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established.

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hypersensitivity Reactions
• Hematological Effects
• Hepatic Effects
• Renal Effects
• Infusion and Injection Site Reactions

Who should not take it

Micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin for injection, or other echinocandins.

Storing it

Storage Conditions

Unopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Store the reconstituted product at 25°C (77°F) [ see Dosage and Administration ( 2.4 )].

Store the diluted solution at 25°C (77°F) [ see Dosage and Administration ( 2.4 )].

Protect from light.

Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.