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Adverse event reporting can be found at the bottom of the page
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Invasive fungal infections in solid organ transplant recipients
Invasive fungal infections and chronic obstructive pulmonary disease
Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.
CRESEMBA® (isavuconazole) is indicated for mucormycosis in patients for whom amphotericin B is inappropriate.1
VITAL was a single-arm, open-label trial which assessed the efficacy and safety of CRESEMBA® for the treatment of mucormycosis and compared its efficacy with amphotericin B in a matched case-control analysis.2
VITAL: the registration trial for CRESEMBA® in mucormycosis2
Primary endpoints
Secondary endpoints
Primary efficacy endpoint, DRC-assessed overall response at day 42 (n=37), demonstrated:
In the case-control analysis (patients with mucormycosis from VITAL matched with controls from the FungiScope registry) survival was similar with CRESEMBA® and amphotericin B.2,b
VITAL: the registration trial for CRESEMBA® in mucormycosis2
The AE profile of CRESEMBA® in VITAL was consistent with observations from the SECURE trial (invasive aspergillosis).2
Most common (≥10%) TEAEs reported for CRESEMBA® in VITAL2
The survival rates and safety profile of CRESEMBA® allow you to prescribe with confidence for your patients with mucormycosis, for whom amphotericin B is inappropriate1,2
a. Oral or intravenous loading regimen determined at the discretion of local investigators.
b. Patients were censored on the day of their last known survival status (circles).
AE, adverse events; AmB, amphotericin B; CI, confidence interval; DRC, data review committee; HR, hazard ratio; IV, intravenous; PO, orally; q8h, every 8 hours; q24h, every 24 hours; TEAE, treatment-emergent adverse events.
Prescribing Information:
Click here for CRESEMBA® (isavuconazole) prescribing information
References:
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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PP-UNP-GBR-7812. January 2024