Isavuconazonium sulfate is a prodrug that is metabolized in vivo to isavuconazole.3006 Isavuconazonium sulfate is available as a lyophilized powder in single-use (preservative-free) vials containing 372 mg of the drug (equivalent to 200 mg of isavuconazole) and mannitol 96 mg.3006 Sulfuric acid also is present to adjust the pH.3006
Each 372-mg vial of isavuconazonium sulfate should be reconstituted with 5 mL of sterile water for injection and gently shaken to completely dissolve the powder.3006 The reconstituted solution should be visually inspected for particulate matter and discoloration.3006 To prepare a 372-mg dose, 5 mL of the reconstituted solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 0.9% or dextrose 5%, yielding an approximate isavuconazonium sulfate concentration of 1.5 mg/mL.3006
Visible translucent to white insoluble particulates of isavuconazole may form in diluted solutions of the drug.3006 The diluted solution should be gently mixed or rolled to minimize the formation of such particulates.3006 Any unnecessary vibration or vigorous shaking should be avoided; pneumatic transport systems should not be used.3006 The final diluted solution must be administered through a 0.2- to 1.2-µm inline filter to remove isavuconazole particulates.3006 A reminder sticker regarding the need for an inline filter should be affixed to the infusion bag.3006
Trade Name(s)
Cresemba
Isavuconazonium sulfate should be administered by intravenous infusion over at least 1 hour after dilution in 250 mL of sodium chloride 0.9% or dextrose 5%.3006 The drug should not be administered by intravenous bolus injection.3006
The final diluted solution of isavuconazonium sulfate must be administered through a 0.2- to 1.2-µm inline filter.3006 The drug should not be infused with other intravenous medications; if a common infusion line is being used to administer other drugs, the line should be flushed with sodium chloride 0.9% or dextrose 5% prior to and following infusion of isavuconazonium sulfate.3006
Intact vials of isavuconazonium sulfate should be stored under refrigeration at 2 to 8°C.3006 Isavuconazonium sulfate is a white to yellow powder that forms a clear solution when reconstituted with sterile water for injection.3006
The manufacturer states that the reconstituted solution should be used immediately, but may be stored below 25°C for up to 1 hour prior to dilution.3006 The total time for storage (of the diluted solution in the infusion bag) and the infusion time together should not exceed 6 hours if stored at room temperature or 24 hours if stored at 2 to 8°C.3006 The infusion solution should not be frozen.3006
Filtration
The diluted solution for infusion must be administered with an infusion set containing a 0.2- to 1.2-µm inline filter to remove insoluble isavuconazole particulates that may form in diluted solutions of the drug.3006
For a list of references cited in the text of this monograph, search the monograph titled References.