Isavuconazonium sulfate

(Cresemba®)

Cresemba®

Drug updated on 5/17/2024

Dosage FormCapsule (oral; 74.5 mg of isavuconazonium sulfate [equivalent to 40 mg of isavuconazole], 186 mg [equivalent to 100 mg of isavuconazole]); Injection (intravenous; 372 mg [equivalent to 200 mg of isavuconazole])
Drug ClassAzole antifungals
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with invasive aspergillosis or invasive mucormycosis, by injection in adults and pediatric patients 1 year of age and older.
  • Indicated for the treatment of adults with invasive aspergillosis or invasive mucormycosis, through capsule administration, in adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater.

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Summary
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  • Isavuconazonium sulfate (Cresemba) is indicated for the treatment of adults with invasive aspergillosis or invasive mucormycosis. It can be administered via injection to adults and pediatric patients 1 year of age and older, and is also suitable for capsule administration in adults and pediatric patients 6 years old who weigh at least 16 kilograms.
  • The effectiveness, safety, comparison with other antifungal agents such as amphotericin B, posaconazole, voriconazole, and considerations for specific population subgroups were derived from seven systematic reviews/meta-analyses.
  • In a study involving over 10,000 patients primarily from Asia with diabetes suffering from Mucormycosis Treatment, Isavuconazonium sulfate showed a mortality rate of 24.6%, which was higher than combination therapy but lower compared to cases where surgery was not an option, indicating potential utility in multimodal treatment plans.
  • A meta-analysis including over three thousand patients demonstrated that Isavuconazonium sulfate was not inferior to other antifungals like amphotericin B, voriconazole, and posaconazole regarding mortality rates and invasive fungal infection rates while showing fewer therapy discontinuations and a reduced incidence of hepatic abnormalities, suggesting a favorable safety profile.
  • Among lung transplant recipients, a group considered to be at high risk, Isavuconazonium sulfate ranked highest among azoles for preventing invasive fungal infections post-lung transplantation, despite very low evidence certainty, which suggests its effectiveness within this demographic group.
  • For patient groups with hematologic malignancies, where there are limitations in available safety data, Isavuconazonium sulfate still offers effective invasive fungal infection prophylaxis, aligning well with tolerability, making it potentially useful even in high-risk settings.

Product Monograph / Prescribing Information

Document TitleYearSource
Cresemba (isavuconazonium sulfate) Prescribing Information.2023Astellas Pharma US, Inc., Northbrook, IL

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines