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Adverse event reporting can be found at the bottom of the page
AboutAbout  CRESEMBA®Invasive fungal infections and risk factorsMeet CRESEMBA ®CRESEMBA® patient profilesEfficacyEfficacyInvasive AspergillosisMucormycosis

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LabelDosingDosingDosingSafety ProfileSafety & TolerabilitySafety ProfileEmerging PopulationsEmerging PopulationsICUInvasive fungal infections in the ICUInvasive fungal infections and influenza

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Invasive fungal infections and COVID-19 (CAPA/CAM)Support & ResourcesResourcesKOL VideosNational/Regional GuidelinesECIL-6 Guidelines
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Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.

Meet CRESEMBA® 
(isavuconazole)

CRESEMBA® (isavuconazole) is indicated in adults for the treatment of invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.1

Choosing an appropriate antifungal drug can be difficult for a variety of reasons, and considerations may include:2-4


Why choose CRESEMBA®?CRESEMBA® is the only azole approved for both invasive aspergillosis and mucormycosis (for whom amphotericin B is inappropriate) and it is endorsed by guidelines1,5–12
  • CRESEMBA® may be used for early targeted therapy while awaiting pathogen confirmation from specific diagnostic tests. Once results become available, therapy should be adjusted accordingly1
  • Because CRESEMBA® may be prescribed while awaiting test results, you can act quickly when you suspect invasive aspergillosis or mucormycosis1,a
a. CRESEMBA® is indicated in adults for the treatment of invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.1CRESEMBA® is as efficacious as the standard of care in both invasive aspergillosis and mucormycosis13,14
  • In the SECURE trial (invasive aspergillosis), both survival rates and overall treatment response were comparableb with CRESEMBA® and voriconazole13
    • Survival rates (ITT): Treatment difference -1.1% (95% CI: -8.9, 6.7) p=0.744
    • Overall treatment response at end of treatment (mITT): 35% (n=50/143) vs 36% (n=47/129). Adjusted treatment difference 1.6% (95% CI: -9.3, 12.6)
  • In the VITAL trial – a single-arm, open-label trial and case control analysis – mucormycosis cases treated with CRESEMBA® as primary treatment (n=37) were matched with controls from the FungiScope Registry who received primary amphotericin B-based treatment14
    • Survival rates were similar with CRESEMBA® and amphotericin B. Weighted all-cause mortality at day 42: 33% vs 41%, p=0.595
Find out more about the efficacy of CRESEMBA® in invasive aspergillosis and mucormycosis

b. Patients were censored on the day of their last known survival statusCRESEMBA® has an improved tolerability profile vs voriconazole, with fewer drug-related adverse events13
  • In the SECURE trial, CRESEMBA® showed significant reductions in the frequency of azole-specific adverse events vs voriconazole for the treatment of invasive aspergillosis13
Scroll left to view table
AEs and treatment discontinuations in the SECURE trial13
  CRESEMBA® (n=257) Voriconazole (n=259) p value
Any TEAE 96% 98% 0.122
Drug-related TEAEs 42% 60% <0.001
TEAEs leading to discontinuation 14% 23% –
Drug-related AEs leading to discontinuation 8% 14% –

Example

Scroll left to view table
Scroll left to view table
Drug-related AEs that were reduced with CRESEMBA® vs voriconazole13
  CRESEMBA®
(n=257)		 Voriconazole (n=259) p value
Skin and subcutaneous tissue disorders 33% 42% 0.037
Eye disorders 15% 27% 0.002
Hepatobiliary disorders 9% 16% 0.016

In the VITAL trial, the AE profile of CRESEMBA® for the treatment of mucormycosis was consistent with observations from the SECURE trial. Only 16% (n=6/37) of patients with mucormycosis discontinued CRESEMBA® due to AEs14

CRESEMBA® is associated with fewer and more manageable drug-drug interactions than other azoles1,3
  • CRESEMBA® interacts with selected CYP450 pathway components to a lesser degree than other azoles1,3,15,16
  • CRESEMBA® can be administered with several medications, including  ibrutinib and some immunosuppressants, without the need to adjust its dose17
Scroll left to view table
Recommendations for the coadministration of CRESEMBA® with key medications4,c
Concomitant medication
  • Proton pump inhibitors
 
  • Statins
 
  • Warfarin
 
  • Methotrexate
 
  • Repaglinide
  • Immunosuppressants (tacrolimus, sirolimus and ciclosporin)
 
  • Short-acting opiates (alfentanyl, fentanyl)
 
  • Digoxin
 
  • Anticancer agents (other than methotrexate) including ibrutinib17
  
  • Dabigatran etexilate
 
  • Midazolam
 
  • Colchicine
Recommendation No dose adjustment for either CRESEMBA® or the concomitant medication Monitoring of concomitant medication and dose adjustment if required

Example

Scroll left to view table

Please refer to the CRESEMBA® Summary of Product Characteristics for full list of drug interactions and recommendations concerning coadministration.

c. CRESEMBA® is contraindicated in coadministration with ketoconazole, high-dose ritonavir, and strong CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long acting barbiturates, phenytoin and St. John’s wort, or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine.1 For further details and a full list of drug interactions, please consult the Summary of Product Characteristics.

CRESEMBA® may be used in patients with renal impairment and mild-to-moderate hepatic impairment without dose adustments1 Renal impairment

CRESEMBA® was specially developed to facilitate intravenous administration, and unlike other azoles it does not require potentially nephrotoxic excipients like cyclodextrin for solubilisation:1,5,6
 
  • It can be used in patients with renal dysfunction – including ESRD – without dose adjustments1
In the SECURE and VITAL trials, kidney function did not affect treatment outcomes with CRESEMBA®18,19
 
  • There was no evidence of loss of efficacy or drug-specific safety concerns in patients with renal impairment18 
  • Median length of hospital stay for patients with moderate-to-severe renal impairment was significantly shorter vs voriconazole for the treatment of invasive aspergillosis (p=0.0032)19
Mild or moderate hepatic impairment 

Risk of hepatotoxicity can be an important consideration when treating with antifungals.
 
  • No dose adjustments of CRESEMBA® is needed in patients with mild or moderate hepatic dysfunction (Child-Pugh Classes A and B)1 
  • Although elevated liver transaminases have been reported in clinical studies, they rarely required treatment discontinuation of CRESEMBA®1. Monitoring of hepatic enzymes should be considered1
    • Conversely, voriconazole has been associated with elevations in Iiver function tests and clinicaI signs of Iiver damage such as jaundice5
  • CRESEMBA® showed significantly improved hepatic tolerability vs voriconazole (frequency of hepatobiliary adverse events: 9% (n=23/257) vs 16% (n=42/259), p=0.016)13
  • CRESEMBA® has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); use in these patients is not recommended unless the potential benefit outweighs the risks. These patients should be carefully monitored for potential drug toxicity1
CRESEMBA® has a simple and reliable dosing regimen, and its high oral bioavailability allows for interchangeable IV and oral dosing1,3
  • CRESEMBA® offers simple and flexible dosing to help with complicated clinical scenarios1,3
  • The oral bioavailability of CRESEMBA® is 98%, allowing for simple conversion between IV and oral administration1
Economic value of CRESEMBA®
  • CRESEMBA® is cost-effective relative to voriconazole for the treatment of invasive aspergillosis (based on a willingness-to-pay threshold of £30,000 per additional QALY)20
  • In patients with renal impairment, CRESEMBA® may reduce costs relative to voriconazole by significantly shortening the length of hospital stay for patients with invasive aspergillosis19
  • CRESEMBA® demonstrated a cost-saving of 36% per-patient treatment for mucormycosis relative to liposomal AmB + posaconazole21,d
d. The population included adult patients receiving primary treatment for mucormycosis. Dosing regimens were as per the respective Summary of Product Characteristics (liposomal AmB: 5 mg/kg; posaconazole – not indicated for mucormycosis: 3 x 100mg oral tablets/day, 600 mg loading dose).

Whether faced with invasive aspergillosis, or mucormycosis where amphotericin B is inappropriate, CRESEMBA® ensures that your patients are covered, and is also recommended by guidelines1,5-12

Which patients can CRESEMBA® help?
View patient profiles LoadingAE, adverse event; AmB, amphotericin B; BTK, Bruton’s tyrosine kinase; ESRD, end-stage renal disease; ITT, intent-to-treat; IV, intravenous; mITT, modified intent-to-treat; PK, pharmacokinetics; QALY, quality-adjusted life year; TEAE, treatment-emergent adverse event.Prescribing Information:

Click here for CRESEMBA® (isavuconazole) and Vfend (voriconazole) prescribing information

References:

1. CRESEMBA GB Summary of Product Characteristics.
2. Donnelley MA et al. Infect Drug Resist 2016;9:79–86.
3. Natesan SK and Chandrasekar PH. Infect Drug Resist 2016;9:291–300.
4. Perfect JR. Nat Rev Drug Discov 2017;16(9):603–616.
5. VFEND GB Summary of Product Characteristics.
6. Noxafil Summary of Product Characteristics.
7. Sporanox Summary of Product Characteristics.
8. Tissot F et al. Haematologica 2017;102(3):433–444.
9. Ullmann AJ et al. Clin Microbiol Infect 2018;24(Suppl. 1):e1–38.
10. Patterson TF et al. Clin Infect Dis 2016;63(4):e1–e60.
11. Cornely OA et al. Lancet Infect Dis 2019;19(12):e405–e421.
12. Cornely OA et al. Lancet Infect Dis 2019;19(12):e405–e421. (Appendix).
13. Maertens JA et al. Lancet 2016;387(10020):760–769.
14. Marty FM et al. Lancet Infect Dis 2016;16(7):828–837.
15. Groll AH et al. Clin Pharmacol Drug Dev 2017;6(1):76–85.
16. Wilson DT et al. Ther Clin Risk Manag 2016;12:1197–1206.
17. Cummins KC et al. Leuk Lymphoma 2019;60(2):527–530.
18. Perfect JR et al. Mycoses 2018;61(7):420–429.
19. Horn D et al. J Med Econ 2016;19(7):728–734.
20. Floros L et al. J Med Econ 2020;23(1):86–97
21. Bagshaw E et al. Future Microbiol 2017;12:515–525.
AboutLearn how CRESEMBA® allows for simple and reliable dosing Dosing information Loading Get more information about the economic value of CRESEMBA® Watch now Loading
PP-CRB-GBR-1777. March 2023

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