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About CRESEMBA®About CRESEMBA®Meet CRESEMBA®CRESEMBA® in the ICUCRESEMBA® in ActionEfficacy EfficacyInvasive AspergillosisEfficacyGuidelines MucormycosisEfficacyGuidelinesSafetySafetyTolerabilityInvasive AspergillosisMucormycosis Safety ProfileSafety ProfileDosingDosingSimple DosingLinear PKs, Low Variability and TDMPractical ConsiderationsReal-world DataReal-world DataReal-world EffectivenessReal-world SafetyResourcesResourcesSummary of Prescribing InformationEventsMaterialsVideos

Helping you stay focused on your patient1–4

  Renal impairment

 

CRESEMBA® is suitable for the renally impaired – even those with ESRD1

CRESEMBA® has no cyclodextrin in its IV formulation, which means that it has reduced potential for renal toxicity compared with other azoles.1,5–7 

It can be used in patients with renal dysfunction, including ESRD, without dose adjustments.1

Treatment outcomes with CRESEMBA® appear to be unaffected by kidney function.8,9 There is no evidence of loss of efficacy or drug safety concerns in patients with renal impairment, and median hospital LOS may be reduced vs voriconazole in patients with moderate-to-severe impairment (p=0.0032).8,9 

With liposomal amphotericin B, nephrotoxicity can be a concern, and renal adverse events are a common reason for treatment discontinuation.10

Could using CRESEMBA® in patients with renal impairment help you stay focused on their underlying condition?

 

Hepatic impairment

CRESEMBA® may simplify treatment in patients with hepatic impairment1

CRESEMBA® has significantly improved hepatic tolerability vs voriconazole: the frequency of drug-related hepatobiliary AEs in the SECURE trial was 9% and 16%, respectively (p=0.016).2

Unlike voriconazole, CRESEMBA® does not require dose adjustments in patients with mild or moderate hepatic dysfunction (Child-Pugh A and B).1,5

Although elevated liver transaminases have been reported, they rarely require treatment discontinuation.1 

CRESEMBA® has not been studied in severe hepatic impairment; use in these patients is not recommended unless the potential benefit outweighs the risks.1 

With liposomal amphotericin B, hepatotoxicity remains a concern, with hepatic adverse events being a common reason for treatment discontinuation.10

Could using CRESEMBA® in patients with hepatic impairment help you stay focused on their underlying condition?

Cardiovascular (QTc)

CRESEMBA® does not cause QTc prolongation1

While voriconazole and posaconazole prolong the QTc interval, CRESEMBA® doesn’t.1,5,6,11 This may be a valuable consideration in patients with proarrhythmic risk.

CRESEMBA® shortens the QTc interval; it is therefore contraindicated in patients with familial short QT syndrome, and should be used with caution in combination with medicines that cause QTc shortening.1

In patients with proarrhythmic risk, could CRESEMBA® be a consideration?

Drug interactions

CRESEMBA® has fewer and more manageable drug–drug interactions than other azoles1,3

Compared with other azoles, CRESEMBA® can help simplify the management of patients taking certain concomitant medications.1,3,5,6

As the table below shows, CRESEMBA® has fewer CYP450 effects vs other azoles.1,3

Comparative inhibition of selected CYP450 isoenzymes by triazoles12


Adapted from reference 12.

This means CRESEMBA® can be administered with several medications without the need to dose-adjust.1

Recommendations for the coadministration of CRESEMBA® with key medications1,a


​​​​​​​Adapted from: reference 12.

This means CRESEMBA® can be administered with several medications without the need to dose-adjust.1


Adapted from reference 1.


CRESEMBA® can be used with ibrutinib

The BTK inhibitor ibrutinib is increasingly being prescribed for the treatment of B-cell malignancies such as CLL, MCL and WM.13–15 Ibrutinib therapy has been associated with an increased incidence of invasive fungal infections, particularly invasive aspergillosis.14–16

Unlike voriconazole, posaconazole and itraconazole, CRESEMBA® can be used with ibrutinib, and coadministration appears to be well tolerated.13,16


a. 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 refer to Local Product Document.
 

AE, adverse event; BTK, Bruton’s tyrosine kinase; CLL, chronic lymphocytic leukaemia; CYP, cytochrome P; ESRD, end-stage renal disease; IV, intravenous; LOS, length of stay; MCL, mantle cell lymphoma; PK, pharmacokinetics; TDM, therapeutic drug monitoring; WM, Waldenström’s macroglobulinaemia.

  

Prescribing Information:

CRESEMBA® (isavuconazole)


References:

Adapted from Local Product Document of CRESEMBA® (Isavuconazole) version LPDCRE052021.Maertens JA et al. Lancet 2016;387(10020):760–769.Natesan SK and Chandrasekar PH. Infect Drug Resist 2016;9:291–300.Perfect JR. Nat Rev Drug Discov 2017;16(9):603–616.Adapted from Local Product Document of VFEND® (Voriconazole) version LPDVRC022022.Posaconazole Summary of Product Characteristics.Donnelley MA et al. Infect Drug Resist 2016;9:79–86.Horn D et al. J Med Econ 2016;19(7):728–734.Perfect JR et al. Mycoses 2018;61(7):420–429.Cornely OA et al. Clin Infect Dis 2007;44(10):1289–1297.Mellinghoff SC et al. Mycoses 2018;61(4):256–260.Wilson DT et al. Ther Clin Risk Manag 2016;12:1197–1206.Ibrutinib Summary of Product Characteristics.Chamilos G et al. Clin Infect Dis 2018;66(1):140–148. Ghez D et al. Blood 2018;131(17):1955–1959.Cummins KC et al. Leuk Lymphoma 2019;60(2):527–530.

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CRESEMBA® IV reconstitution, dilution and administration

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