Information on how to access prescribing information and adverse event reporting can be found at the bottom of the page.
†Oral or intravenous loading regimen determined at the discretion of local investigators.
EOT, end of treatment; IV, intravenous; od, once daily; PO, orally; q8h, every 8 hours; q24h, every 24 hours.
*The VITAL study is the first trial to show the efficacy and safety of CRESEMBA for the treatment of mucormycosis, either when given for primary treatment, for refractory disease, or as an alternative in patients intolerant to amphotericin B.
Mucormycosis is an extremely rare disease which means that recruiting the numbers of patients needed for randomised controlled trials is impractical. For these reasons, the VITAL study was designed as an open-label, uncontrolled trial. To put the all-cause mortality rates and overall response rates from VITAL into context, the US FDA and the European EMA CHMP requested additional analyses in the context of external control data. As a result, a matched case-control analysis using contemporaneous controls from the FungiScope database was also performed. This case-control analysis showed CRESEMBA has similar efficacy compared with primary amphotericin B-based treatment.
Prescribing Information for Cresemba (isavuconazole)
Cresemba (isavuconazole) 100mg hard capsules
Cresemba (isavuconazole) 200mg powder for concentrate for solution for infusion
Cresemba (Isavuconazole) 100mg hard capsules and Cresemba (Isavuconazole) 200mg powder for concentrate for solution for infusion
Prescribing Information for Vfend (voriconazole)
Vfend (voriconazole) 50mg film coated tablets
Vfend (voriconazole) 200mg film coated tablets
Vfend (voriconazole) 200mg powder for solution for infusion
Vfend (voriconazole) 40mg/ml powder for oral suspension
Vfend (voriconazole): 50mg film coated tablets, 200mg film coated tablets & 40mg/ml powder for oral suspension
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