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Isavuconazonium Sulfate

    Brands

    DEA Class; Rx

    Common Brand Names; Cresemba, isavuconazole

    • Antifungals, Systemic; 

    Oral and injectable azole antifungal
    Used for the treatment of invasive aspergillosis or invasive mucormycosis
    Bioequivalence between oral and intravenous formulations established

    Indicated for invasive aspergillosis

    Has activity against most strains of the following microorganisms, both in vitro and in clinical infection: Aspergillus flavus, Aspergillus fumigatus, and Aspergillus niger

    Indicated for invasive mucormycosis caused by Mucorales fungi such as Rhizopus oryzae and Mucormycetes species

    Hypersensitivity

    Coadministration with strong CYP3A4 inhibitors or inducers

    Familial short QT syndrome; isavuconazole shortens the QTc interval in a concentration-related manner

    • Nausea (27.6%)
    • Vomiting (24.9%)
    • Diarrhea (23.7%)
    • Hypokalemia (19.1%)
    • Elevated liver tests (17.1%)
    • Dyspnea (17.1%)
    • Abdominal pain (16.7%)
    • Headache (16.7%)
    • Peripheral edema (15.2%)
    • Constipation (14%)
    • Fatigue (10.5%)
    • Insomnia (10.5%)
    • Back pain (10.1%)
    • Renal failure (10.1%)
    • Chest pain (8.9%)
    • Decreased appetite (8.6%)
    • Delirium (8.6%)
    • Rash (8.6%)
    • Pruritus (8.2%)
    • Hypotension (8.2%)
    • Anxiety (8.2%)
    • Acute respiratory failure (7.4%)
    • Injection site reaction (6.2%)
    • Dyspepsia (6.2%)
    • Hypomagnesemia (5.4%)

    Hepatic adverse drug reactions (eg, elevated ALT, AST, alkaline phosphatase, total bilirubin) reported; the elevations in liver-related laboratory tests were generally reversible and did not require discontinuation of drug; cases of more severe hepatic adverse drug reactions, including hepatitis, cholestasis, or hepatic failure including death, have been reported in patients with serious underlying medical conditions (eg, hematologic malignancy) during treatment with azole antifungal agents

    Infusion-related reactions, including hypotension, dyspnea, chills, dizziness, paresthesia, and hypoesthesia, were reported; discontinue the infusion if these reaction occur

    May cause fetal harm when administered to a pregnant woman

    Anaphylactic reactions, with fatal outcome, reported during treatment; symptoms including dyspnea, hypotension, generalized erythema with flushing, and urticaria reported often soon after initiation of treatment

    Based on findings from animal studies, fetal harm may occur when administered to pregnant women

    Isavuconazole was present in the milk of lactating rats following IV administration

    Thus, drug may be present in human milk

    Therefore, breastfeeding should be discontinued during treatment

    Adults

    1116 mg/day isavuconazonium (equivalent to 600 mg/day isavuconazole) PO or IV.

    Geriatric

    1116 mg/day isavuconazonium (equivalent to 600 mg/day isavuconazole) PO or IV.

    Adolescents

    Safety and efficacy not established.

    Children

    Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    Neonates

    Safety and efficacy not established.

    Isavuconazonium sulfate

    capsule

    • 186mg isavuconazonium sulfate (equivalent to 100mg isavuconazole)

    injection, lyophilized powder for reconstitution

    • 372mg isavuconazonium sulfate (equivalent to 200mg isavuconazole)