CASPOFUNGIN ACETATE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

caspofungin acetate (UNII: VUW370O5QE) (caspofungin - UNII:F0XDI6ZL63)

Available from:

Alvogen Inc.

INN (International Name):

caspofungin acetate

Composition:

caspofungin acetate 5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.1, 14.5)]. Caspofungin acetate for injection is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.2, 14.5)] . Limitations of Use : Caspofungin acetate for injection has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida. Caspofungin acetate for injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.3, 14.5)] . Limitations of Use : Caspofungin acetate for injection has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the

Product summary:

Caspofungin Acetate for Injection is supplied as follows: Caspofungin Acetate for Injection is a lyophilized white to off-white powder/cake for intravenous infusion in a vial with an aluminum flip off seal and plastic cap. The lyophilized vials should be stored refrigerated at 2° to 8°C (36° to 46°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CASPOFUNGIN ACETATE- CASPOFUNGIN ACETATE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
ALVOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CASPOFUNGIN ACETATE FOR INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CASPOFUNGIN ACETATE FOR INJECTION.
CASPOFUNGIN ACETATE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Dosage and Administration
Preparation for Administration (2.6)
08/2017
Warnings and Precautions, Hypersensitivity (5.1)
08/2017
INDICATIONS AND USAGE
Caspofungin acetate for injection is an echinocandin antifungal
indicated in adults and pediatric patients (3 months of age
and older) for:
Empirical therapy for presumed fungal infections in febrile,
neutropenic patients. (1)
Treatment of candidemia and the following _Candida_ infections:
intra-abdominal abscesses, peritonitis and pleural space
infections. (1)
Treatment of esophageal candidiasis. (1)
Treatment of invasive aspergillosis in patients who are refractory to
or intolerant of other therapies. (1)
DOSAGE AND ADMINISTRATION
_Important Administration Instructions for All Patients (2.1):_
Administer by slow intravenous (IV) infusion over approximately 1
hour. Do not administer by IV bolus administration.
Do not mix or co-infuse caspofungin acetate for injection with other
medications. Do not use diluents containing
dextrose (α-D-glucose).
_Dosage in Adults [18 years of age and older] (2.2):_
Administer a single 70 mg loading dose on Day 1, followed by 50 mg
once daily for all indications except esophageal
candidiasis.
For esophageal candidiasis, use 50 mg once daily with no loading dose.
_Dosage in Pediatric Patients [3 months to 17 years of age] (2.3):_
Dosing should be based on the patient's body surface area.
For all indications, administer a single 70 mg/m loading dose on Day
1, followed by 50 mg/m once daily thereafter.
Maximum loading dose and daily maintenance dose should not exceed 70
mg, regardless of the pati