RX ITEM-Cresemba 186Mg Cap 14 By Astellas Pharma

CRESEMBA- isavuconazonium sulfate capsule
CRESEMBA- isavuconazonium sulfate injection, powder, lyophilized, for solution
Astellas Pharma US, Inc.

1 INDICATIONS AND USAGE

1.1 Invasive Aspergillosis
CRESEMBA is an azole antifungal indicated for patients 18 years of age and older for the treatment of invasive aspergillosis.

[see Clinical Studies (14.1) and Clinical Pharmacology (12.4)].

1.2 Invasive Mucormycosis


CRESEMBA is an azole antifungal indicated for patients 18 years of age and older for the treatment of invasive mucormycosis.

[see Clinical Studies (14.2) and Clinical Pharmacology (12.4)].

1.3 Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

2 DOSAGE AND ADMINISTRATION

2.1 Important Instructions for Intravenous Administration
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Intravenous formulation must be administered via an infusion set with an in-line filter (pore size 0.2 to 1.2 micron).
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Infuse the intravenous formulation over a minimum of 1 hour in 250 mL of a compatible diluent, to reduce the risk for infusion-related reactions. Do not administer as an intravenous bolus injection.
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Do not infuse CRESEMBA with other intravenous medications.
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Flush intravenous lines with 0.9% sodium chloride injection, USP or 5% dextrose injection, USP prior to and after infusion of CRESEMBA.
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After dilution of the intravenous formulation, avoid unnecessary vibration or vigorous shaking of the solution. Do not use a pneumatic transport system.

RX ITEM-Cresemba 186Mg Cap 14 By Astella
NDC 00469-0320-14 UPC/GTIN No.3-04690-32014-2 Mfg.Part No.32014

Cresemba 186Mg Cap 14 By Astellas Pharma
BRAND: CRESEMBA NDC: 00469-0320-14,469032014 UPC: 3-04690-32014-2,304690320142 Astellas USA, Inc.

ISAVUCONAZONIUM SULFATE O
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