CRESEMBA® in Mucormycosis

Prescribing information is available at the bottom of this page.

The VITAL trial was undergone to assess the efficacy and safety of isavuconazole for treatment of mucormycosis and to compare
its efficacy with amphotericin B in a matched case-control analysis.

Please click here to view the VITAL clinical trial summary.

VITAL Study Design

Primary endpoint 

Efficacy:

  • Overall response at Day 42 assessed by a data review committee

Secondary endpoints

Efficacy:

  • Assessments of overall, clinical, radiological and mycological responses at Day 42, Day 84 and end of treatment

  • Crude and weighted mortality at Days 42 and 84

  • Matched case-control analysis using the FungiScope: Global Emerging Fungal Infection Registry for Day 42 crude all-cause mortality

*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.

References

  1. CRESEMBA Summary of Product Characteristics. 
  2. Marty FM, Ostrosky-Zeichner L, Cornely OA, et al. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016;16(7):828–837.
  3. Spellberg B, et al. Recent advances in the management of mucormycosis: from bench to bedside. Clin Infect Dis. 2009;48(12):1743-151.    
  4. Falci DR and Pasqualotto AC, et al. Profile of isavuconazole and its potential in the treatment of severe invasive fungal infections. Infect Drug Resist. 2013;6:163-174.

In the VITAL trial, CRESEMBA was found effective against mucormycosis2. CRESEMBA provides an additional, much-needed treatment option for mucormycosis1,3.

Efficacy data in mucormycosis

* Data are n (%) or n/N (%). Overall response was assessed by an independent data review committee and was based on individual clinical, mycological, and radiological response assessments.
DRC – data review committee; IQR – interquartile range.

References

  1. CRESEMBA Summary of Product Characteristics. 
  2. Marty FM, Ostrosky-Zeichner L, Cornely OA, et al. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016;16(7):828–837.
  3. Spellberg B, et al. Recent advances in the management of mucormycosis: from bench to bedside. Clin Infect Dis. 2009;48(12):1743-151.    
  4. Falci DR and Pasqualotto AC, et al. Profile of isavuconazole and its potential in the treatment of severe invasive fungal infections. Infect Drug Resist. 2013;6:163-174.

In the VITAL trial, CRESEMBA demonstrated similar survival outcomes to amphotericin B in mucormycosis2
CRESEMBA provides similar efficacy to amphotericin B, showing that it is as effective as standard of care2

Survival data in mucormycosis

Patients treated with isavuconazole were matched with controls from the FungiScope Registry, who received treatment with amphotericin B. 
*Calculated from Fisher’s exact test. 
Calculated from x² test. ‡Weights were applied according to the rato of the number of controls matched to each case.

In the VITAL trial, CRESEMBA® demonstrated similar survival rates to amphotericin B in mucormycosis2.

Survival data in mucormycosis

HR - hazard ratio.

References

  1. CRESEMBA Summary of Product Characteristics. 
  2. Marty FM, Ostrosky-Zeichner L, Cornely OA, et al. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016;16(7):828–837.
  3. Spellberg B, et al. Recent advances in the management of mucormycosis: from bench to bedside. Clin Infect Dis. 2009;48(12):1743-151.    
  4. Falci DR and Pasqualotto AC, et al. Profile of isavuconazole and its potential in the treatment of severe invasive fungal infections. Infect Drug Resist. 2013;6:163-174.

 

In the VITAL trial, CRESEMBA® had a favourable safety profile for your fragile* difficult-to-treat patients with mucormycosis2

TEAEs in mucormycosis

Reported in 10% or more of patients.

References

  1. CRESEMBA Summary of Product Characteristics. 
  2. Marty FM, Ostrosky-Zeichner L, Cornely OA, et al. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016;16(7):828–837.
  3. Spellberg B, et al. Recent advances in the management of mucormycosis: from bench to bedside. Clin Infect Dis. 2009;48(12):1743-151.    
  4. Falci DR and Pasqualotto AC, et al. Profile of isavuconazole and its potential in the treatment of severe invasive fungal infections. Infect Drug Resist. 2013;6:163-174.

Prescribing Information

This includes legal category, basic NHS cost and a link to SPC. Please click each relevant SPC link to be directed to EMC website.

 
Cresemba® (isavuconazole)
Cresemba® 100mg hard capsules – SPC
Legal Category: POM. Basic NHS Cost:14 caps pack £599.28
Cresemba® 200mg powder for concentrate for solution for infusion – SPC
Legal Category: POM Basic NHS Cost: 1 vial pack £297.84

 

Vfend® (Voriconazole)
Vfend® 50mg filmed tablets – SPC
Legal Category: POM. Basic NHS Cost: 28 tabs £275.68
Vfend® 200mg filmed tablets – SPC
Legal Category: POM. Basic NHS Cost: 28 tabs £1102.74
Vfend® 200mg powder for solution for infusion – SPC
Legal Category: POM. Basic NHS Cost: 1 vial £77.14
Vfend® 40mg/ml Powder for oral suspension – SPC
Legal Category: POM Basic NHS Cost: 75ml £551.37

PP-CRB-GBR-0804.  October 2020