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:

Sagent Pharmaceuticals

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 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 - 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. Additional pediatric use information is approved for Astellas Pharma US, Inc.'s Mycamine ® (micafungin for injection). However, due to Astellas Pharma US, Inc.'s mark

Product summary:

Micafungin for injection is supplied as a sterile, white lyophilized powder for reconstitution for intravenous infusion in vials coated with a light protective film, and is available as follows: 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). [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. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MICAFUNGIN- MICAFUNGIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
SAGENT PHARMACEUTICALS
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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 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
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 MONTHS AND
OLDER 30 KG OR LESS
PEDIATRIC PATIENTS 4 MONTHS AND
OLDER GREATER THAN 30 KG
TREATMENT OF CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, _CANDIDA
_PERITONITIS AND
ABSCESSES
100 mg daily
2 mg/kg/day
(maximum 100 mg daily)
TREATMENT OF ESOPHAGEAL CANDIDIASIS
150 mg daily
3 mg/kg/day
2.5 mg/kg/day
(maximum 150 mg daily)
PROPHYLAXIS OF _CANDIDA _INFECTIONS IN HSCT RECIPIENTS
50 mg daily
1 mg/kg/day
(maximum 50 mg daily)
Infuse over 1 hour. (2.5)
See Full Prescribing Information for intravenous (IV) preparation and
administration instructions. (2)
DOSAGE FORMS AND STRENGTHS
For injection: 50 mg single-dose vial. (3)
For injection: 100 mg single-dose vial. (3)
CONTRAINDICATIONS
Micafungin for