MICAFUNGIN- micafungin sodium injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Micafungin Sodium (UNII: IS1UP79R56) (Micafungin - UNII:R10H71BSWG)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 [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 Micafungin for Injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatri

Product summary:

Micafungin for Injection is supplied as a sterile, white lyophilized powder for reconstitution for intravenous infusion, and is available in the following packaging configurations: Storage Unopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MICAFUNGIN- MICAFUNGIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MICAFUNGIN FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MICAFUNGIN FOR
INJECTION.
MICAFUNGIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Indications and Usage (1)
12/2019
Dosage and Administration, Dosage for Pediatric Patients Younger than
4 Months of Age (2.3)
12/2019
Warnings and Precautions, Infusion and Injection Site Reactions (5.5)
12/2019
INDICATIONS AND USAGE
Micafungin for 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.
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 (HSCT).
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. (1, 2.3, 8.4)
Micafungin for Injection has not been adequately studied in patients
with endocarditis, osteomyelitis or
meningoencephalitis due to _Candida_. (1)
The efficacy of Micafungin for Injection against infections caused by
fungi other than _Candida_ has not been established.
(1)
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSAGE ADMINISTERED BY INDICATION, WEIGHT AND AGE (2.1,
2.2, 2.3, 8.4)
ADULT
PEDIATRIC PATIENTS 4