Drug updated on 9/4/2024
| Dosage Form | Capsule (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 Class | Azole 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
- Cresemba (isavuconazonium sulfate) is indicated for the treatment of adults and pediatric patients, 1 year of age and older, with invasive aspergillosis or invasive mucormycosis by injection. It is also indicated for the treatment of adults and pediatric patients, 6 years of age and older weighing 16 kilograms (kg) or more, with invasive aspergillosis or invasive mucormycosis through capsule administration.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Mucormycosis Treatment: Isavuconazole was associated with a mortality rate of 24.6% in mucormycosis treatment, compared to 31.5% with amphotericin B monotherapy, 6.6% with amphotericin B combined with azole, and 17.2% with posaconazole monotherapy.
- Invasive Fungal Infections (IFIs) and Invasive Aspergillosis (IA)/Invasive Mucormycosis (IM) Treatment: Isavuconazole demonstrated comparable mortality (OR 1.11, 95% CI 0.82-1.51) and IFI rates (OR 1.02, 95% CI 0.49-2.12) to other antifungals and showed efficacy similar to voriconazole for IA and liposomal amphotericin B for IM.
- Prophylaxis in Lung Transplant Recipients and Hematologic Malignancies: Isavuconazole ranked highest among azoles in preventing IA/IFI in lung transplant recipients (with very low certainty of evidence) and was effective for IFI prophylaxis in patients with hematologic malignancies.
- Discontinuation Rate Due to Adverse Events: Isavuconazole significantly reduced the discontinuation rate due to adverse events compared to other antifungal agents (OR 1.96, 95% CI 1.26-3.07).
- Incidence of Abnormal Hepatic Function: Isavuconazole had a lower incidence of hepatic function abnormalities in treatment (OR 2.31, 95% CI 1.41-3.78) and prophylaxis (OR 3.63, 95% CI 1.31-10.05) compared to other antifungal agents.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cresemba (isavuconazonium sulfate) Prescribing Information. | 2023 | Astellas Pharma US, Inc., Northbrook, IL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| A systematic review of the therapeutic outcome of mucormycosis. | 2023 | Open Forum Infectious Diseases |
| Population pharmacokinetics of isavuconazole in adult: a systematic review. | 2023 | Infection and drug resistance |
| A systematic review and meta-analysis of efficacy and safety of isavuconazole for the treatment and prophylaxis of invasive fungal infections. | 2023 | Mycoses |
| Clinical research advances of isavuconazole in the treatment of invasive fungal diseases. | 2022 | Frontiers in Cellular and Infection Microbiology |
| Antifungal prophylaxis in adult lung transplant recipients: Uncertainty despite 30 years of experience. a systematic review of the literature and network meta-analysis. | 2022 | Transplant Infectious Disease |
| Effectiveness and safety of isavuconazole prophylaxis for invasive fungal infections in the haematologic setting. | 2022 | Hematology |
| Antifungal therapeutic drug monitoring: focus on drugs without a clear recommendation. | 2020 | Clinical Microbiology and Infection |