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Cresemba Dosage

Generic name: ISAVUCONAZONIUM SULFATE 186mg
Dosage form: capsule, injection

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Important Instructions for Intravenous Administration

Intravenous formulation must be administered via an infusion set with an in-line filter (pore size 0.2 to 1.2 micron).
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.
Do not infuse CRESEMBA with other intravenous medications.
Flush intravenous lines with 0.9% sodium chloride injection, USP or 5% dextrose injection, USP prior to and after infusion of CRESEMBA.
After dilution of the intravenous formulation, avoid unnecessary vibration or vigorous shaking of the solution. Do not use a pneumatic transport system.

Dosage Regimen

CRESEMBA (isavuconazonium sulfate) is the prodrug of isavuconazole, an azole antifungal drug. Prescribe CRESEMBA as shown in Table 1 below.

Table 1. Dosage Regimen for CRESEMBA
a 372 mg of isavuconazonium sulfate is equivalent to 200 mg of isavuconazole
b 186 mg of isavuconazonium sulfate is equivalent to 100 mg of isavuconazole
c Start maintenance doses 12 to 24 hours after the last loading dose

Loading Dose

Maintenance Dosec

CRESEMBA for Injection

372 mga of isavuconazonium sulfate per vial

1 reconstituted vial (372 mga)

intravenously

every 8 hours for 6 doses (48 hours)

1 reconstituted vial (372 mga)

intravenously

once daily

CRESEMBA Capsules

186 mgb of isavuconazonium sulfate per capsule

2 capsules (372 mga)

orally

every 8 hours for 6 doses (48 hours)

2 capsules (372 mga)

orally

once daily

Switching between the intravenous and oral formulations of CRESEMBA is acceptable as bioequivalence has been demonstrated. Loading dose is not required when switching between formulations.

With oral administration, swallow capsules whole. Do not chew, crush, dissolve, or open the capsules. CRESEMBA capsules can be taken with or without food.

Reconstitution Instructions for the Injection Formulation

Aseptic technique must be strictly observed in all handling since no preservative or bacteriostatic agent is present in CRESEMBA or in the materials specified for reconstitution. CRESEMBA is water soluble, preservative-free, sterile, and nonpyrogenic.

Reconstitute one vial of CRESEMBA by adding 5 mL water for injection, USP to the vial.
Gently shake to dissolve the powder completely.
Visually inspect the reconstituted solution for particulate matter and discoloration. Reconstituted CRESEMBA should be clear and free of visible particulate.
The reconstituted solution may be stored below 25°C for maximum 1 hour prior to preparation of the patient infusion solution.

Dilution and Preparation Instructions for the Injection Formulation

Remove 5 mL of the reconstituted solution from the vial and add it to an infusion bag containing 250 mL (approximately 1.5 mg isavuconazonium sulfate per mL) of compatible diluent. The diluted solution may show visible translucent to white particulates of isavuconazole (which will be removed by in-line filtration).
Use gentle mixing or roll bag to minimize the formation of particulates. Avoid unnecessary vibration or vigorous shaking of the solution.
Apply in-line filter with a microporous membrane pore size of 0.2 to 1.2 micron and in-line filter reminder sticker to the infusion bag.
Do not use a pneumatic transport system.
The intravenous administration should be completed within 6 hours of dilution at room temperature. If this is not possible, immediately refrigerate (2° to 8°C / 36° to 46°F) the infusion solution after dilution and complete the infusion within 24 hours. Do not freeze the infusion solution.

Compatibility for the Injection Formulation

CRESEMBA for injection should only be administered with the following diluents:

0.9% sodium chloride injection, USP
5% dextrose injection, USP
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