CRESEMBA (isavuconazonium)
SELF-ADMINISTRATION - ORAL
OFFICE-ADMINISTRATION - IV INJECTION
FDA Approved Indications:
- Treatment of invasive aspergillosis
- Treatment of invasive mucormycosis
Prior authorization criteria:
- Prescribed by or in collaboration with a specialist, AND
- Patient is 18 years of age or older, AND
- Patient is being treated for invasive aspergillosis or invasive mucormycosis, AND
- Patient has tried and failed or is unable to take voriconazole, AND
- Patient is not taking a strong CYP3A4 inhibitor or strong CYP3A4 inducer concomitantly with Cresemba, AND
- Cresemba is contraindicated in patients with familial short QT syndrome
- Use with caution in patients with severe liver impairment (Child-Pugh class C), and liver function tests should be monitored
Dosing:
- Loading Dose: 372 mg isavuconazonium sulfate (equivalent to 200 mg of isavuconazole) every 8 hours for 6 doses (48 hours) via oral (2 capsules) or IV administration (1 reconstituted vial)
- Maintenance Dose: 372 mg isavuconazonium sulfate (equivalent to 200 mg of isavuconazole) once daily via oral (2 capsules) or IV administration (1 reconstituted vial) starting 12 to 24 hours after the last loading dose
- Switching between the IV and oral formulations of Cresemba is acceptable as bioequivalence has been demonstrated. Loading dose in not required when swithcing between formulations.
Approval:
- 12 weeks