MICAFUNGIN 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:

Northstar Rx 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 have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than

Product summary:

Micafungin for injection is supplied as a sterile, white color lyophilized powder or cake in an amber glass vial for reconstitution for intravenous infusion and are 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 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
NORTHSTAR RX 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
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 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 has not been adequately studied in patients with
endocarditis, osteomyelitis or
meningoencephalitis due to _Candida._(1)
The efficacy of micafungin 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 MONTHS
AND OLDER 30 KG OR LESS
PEDIATRIC PATIENTS 4 MONTHS
AND OLDER GREATER THAN 30 KG
PEDIATRIC PATIENTS
YOUNGER THAN 4 MONTHS OF
AGE
TREATMENT OF CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, _CANDIDA_
PERITONITIS AND
ABSCESSES
100
mg
daily
2 mg/kg/day (maximum 100 mg daily)
See below
TREA