Classes
DEA Class; Rx
Common Brand Names; Cresemba, isavuconazole
- Antifungals, Systemic;
Description
Oral and injectable azole antifungal
Used for the treatment of invasive aspergillosis or invasive mucormycosis
Bioequivalence between oral and intravenous formulations established
Indications
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
Contraindications
Hypersensitivity
Coadministration with strong CYP3A4 inhibitors or inducers
Familial short QT syndrome; isavuconazole shortens the QTc interval in a concentration-related manner
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
1116 mg/day isavuconazonium (equivalent to 600 mg/day isavuconazole) PO or IV.
1116 mg/day isavuconazonium (equivalent to 600 mg/day isavuconazole) PO or IV.
Safety and efficacy not established.
Safety and efficacy not established.
Safety and efficacy not established.
Safety and efficacy not established.
How supplied
Isavuconazonium sulfate
capsule
- 186mg isavuconazonium sulfate (equivalent to 100mg isavuconazole)
injection, lyophilized powder for reconstitution
- 372mg isavuconazonium sulfate (equivalent to 200mg isavuconazole)
