Drug updated on 5/2/2024
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.
Summary
- Isavuconazonium sulfate (Cresemba) is used for the treatment of adults with invasive aspergillosis or invasive mucormycosis.
- A total of 3 systematic reviews/meta-analyses were reviewed, providing insights into the effectiveness and safety profile of this drug in different patient populations.
- In patients with haematologic malignancies who are at high risk for developing invasive fungal infections (IFIs), evidence from eight studies suggests that isavuconazole may be effective for IFI prophylaxis. However, these studies often lacked safety data and were based on small patient populations from single centres.
- For lung transplant recipients, a network meta-analysis ranked isavuconazole among the top azole antifungals in preventing IA/IFI when used as part of universal prophylaxis post-transplantation. The certainty level was very low due to lack of robust data from randomized controlled trials.
- Comparing efficacy between isavuconazole and voriconazole in treating Aspergillus pathogens showed no relationship with clinical outcomes where MICs were less than 16 µg/ml for either drug. Reduced efficacy might occur against pathogens having drug MICs equal to or greater than 16 µg/ml.
- Despite promising results, further research including larger sample sizes across multiple centers are needed to confirm these findings about Cresemba's effectiveness and safety profile especially within high-risk hematologic populations.
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 |