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Capsule: Swedish Orange (reddish-brown) capsule body marked with "100" in black ink and a white cap marked with "C" in black ink. Capsules length: 24.2 mm.
Each capsule contains 186.3 mg isavuconazonium sulfate (equivalent to 100 mg isavuconazole).
Lyophilized powder for concentrate for solution for IV infusion: Each vial contains 372.6 mg isavuconazonium sulfate (equivalent to 200 mg isavuconazole).
Isavuconazonium Sulfate is a white to yellow powder chemically described as [2-[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-1,3-thiazol-2-yl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-1,2,4-triazol-4-ium-4-yl]ethoxycarbonyl-methylamino]pyridin-3-yl]methyl 2-(methylamino)acetate; hydrogen sulfate.
Isavuconazonium Sulfate is the sulfate ester form of isavuconazonium, a prodrug of the triazole antifungal agent isavuconazole, with broad-spectrum antifungal activity. Upon administration, isavuconazonium sulfate is hydrolyzed by plasma esterases to yield the active moiety isavuconazole. Isavuconazole binds to and inhibits the fungal cytochrome P450 family enzyme lanosterol14-alpha-demethylase (CYP51), which catalyzes the demethylation of lanosterol to yield ergosterol, an important component of the fungal cell membrane. Inhibition of CYP51 leads to a decrease in fungal ergosterol production and disrupts synthesis of the fungal cell membrane, which decreases membrane integrity, increases cell membrane permeability and promotes the loss of essential intracellular elements. This results in fungal cell lysis and death.
Excipients/Inactive Ingredients: Capsule: Capsule contents: magnesium citrate (anhydrous), cellulose microcrystalline, talc, colloidal anhydrous silica and stearic acid.
Capsule shell: hypromellose, iron oxide red, titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium lauril sulfate.
Printing ink: shellac, propylene glycol, ammonia solution (concentrated), iron oxide black.
Lyophilized powder for concentrate for solution for IV infusion: Mannitol, sulfuric acid (for pH-adjustment).
