Isavuconazoniumdrug info
isavuconazonium sulfate 186 MG Oral Capsule [Cresemba]
What it is used for
CRESEMBA ® is an azole antifungal indicated for the treatment of: Invasive aspergillosis and Invasive mucormycosis as follows:
CRESEMBA for injection: adults and pediatric patients 1 year of age and older
CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater
1.1 Invasive
Aspergillosis CRESEMBA ® is indicated for the treatment of invasive aspergillosis as follows: CRESEMBA for injection: adults and pediatric patients 1 year of age and older CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater
1.2 Invasive
Mucormycosis CRESEMBA is indicated for the treatment of invasive mucormycosis as follows: CRESEMBA for injection: adults and pediatric patients 1 year of age and older CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kg and greater, Clinical Studies and Clinical Pharmacology ] 1.3 Usage 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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective April 25, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
CRESEMBA contains isavuconazonium sulfate, which is the prodrug of isavuconazole, an azole antifungal drug. Isavuconazonium sulfate drug substance is an amorphous, white to yellowish-white powder. The chemical name of isavuconazonium sulfate is glycine, N -methyl-, [2-[[[1-[1-[(2 R,3 R )-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-4 H -1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridinyl]methyl ester, sulfate (1:1). The empirical formula is C 35 H 35 F 2 N 8 O 5 S·HSO 4, the molecular weight is 814.84 and the structural formula is: CRESEMBA Capsules CRESEMBA (isavuconazonium sulfate) 74.5 mg capsules are available for oral administration. Each CRESEMBA capsule contains 74.5 mg isavuconazonium sulfate, equivalent to 40 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA (isavuconazonium sulfate) 186 mg capsules are available for oral administration. Each CRESEMBA capsule contains 186 mg isavuconazonium sulfate, equivalent to 100 mg isavuconazole. The inactive ingredients include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc and titanium dioxide. CRESEMBA for Injection CRESEMBA (isavuconazonium sulfate) for injection is available for intravenous administration. CRESEMBA for injection is a white to yellow sterile, lyophilized powder containing 372 mg isavuconazonium sulfate, equivalent to 200 mg isavuconazole, per vial. Inactive ingredients included in each vial are 96 mg mannitol and sulfuric acid for pH adjustment. Isavuconazonium sulfate Structural Formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective April 25, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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