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These highlights do not include all the information needed to use CRESEMBA® safely and effectively. See full prescribing information for CRESEMBA®. CRESEMBA® (isavuconazonium sulfate) capsules, for oral useCRESEMBA® (isavuconazonium sulfate) for injection, for intravenous useInitial U.S. Approval: 2015
Medication labelWhy this: Advisory · dailymed-prescription
CRESEMBA ® is indicated for the treatment of invasive aspergillosis as follows: CRESEMBA for injection: adults and pediatric patients 1 year of age and older [see Clinical Studies (14.1) and Clinical Pharmacology (12.4)] CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater [see Dosage and Administration (2.3) Clinical Studies ( 14.1 ) and Clinical Pharmacology (12.4)] CRESEMBA is indicated for the treatment of invasive mucormycosis as follows: CRESEMBA for injection: adults and pediatric patients 1 year of age and older [see Clinical Studies (14.1) and Clinical Pharmacology (12.3, 12.4)] CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kg and greater [see Dosage and Administration (2.3)], Clinical Studies (14.1) and Clinical Pharmacology (12.3, 12.4)] Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
- generic_name
- isavuconazonium sulfate
- product_names
- isavuconazonium sulfate
- ndc
- 0469-0520, 0469-0520-02, 0469-0420, 0469-0420-01, 0469-2860, 0469-2860-35
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en