Prescription medicine
Isavuconazonium Brand names: Cresemba
Isavuconazonium (Cresemba) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $114.00 per Cresemba 186 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the isavuconazonium FDA label on DailyMed (effective April 25, 2025, Astellas Pharma US, Inc.); the NDA 207500 record on Drugs@FDA; every isavuconazonium label on DailyMed.
Highlights of the record
FDA label of April 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCRESEMBA ® is an azole antifungal indicated for the treatment of: Invasive aspergillosis ( 1.1 ) and Invasive mucormycosis ( 1.2 ) 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
Forms and strengths
- 40 mg
- 100 mg
- 40 mg/ml
Capsule; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- March 6, 2015 Cresemba, Astellas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 14, 2028 Cresemba capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $114.00 per capsule Cresemba 186 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,649 through July 30, 2026
What is isavuconazonium used for?
From the label: indications and usageCRESEMBA ® is an azole antifungal indicated for the treatment of: Invasive aspergillosis ( 1.1 ) and Invasive mucormycosis ( 1.2 ) 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 [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 […]
FDA pharmacologic class: Azole Antifungal.
Source: FDA drug label (CRESEMBA), Astellas Pharma US, Inc., effective April 25, 2025 (SPL set 8f7f73b8-586a-4df0-935f-fecd4696c16c), via openFDA; the full label on DailyMed
Is there a generic for isavuconazonium (Cresemba)?
No generic isavuconazonium is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Cresemba capsules: the compound patent runs to October 31, 2025 (pediatric exclusivity to April 30, 2026), and the last listed entry to March 14, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for isavuconazonium (Cresemba)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $114.00 per Cresemba 186 mg capsule, up 3% from $110.77 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cresemba 186 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cresemba 186 mg capsule | Brand | $114.00 per capsule | $3,419.94 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the isavuconazonium label say about other medicines?
The isavuconazonium label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name isavuconazonium. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | drug interactions | Atorvastatin Use with Caution Caution should be used when atorvastatin is used with CRESEMBA due to a potential increase in atorvastatin exposure. |
| Bupropion | drug interactions | Bupropion Use with Caution Concomitant administration of CRESEMBA and bupropion results in decrease in bupropion exposure. |
| Carbamazepine | contraindications | Coadministration of strong CYP3A4 inducers, such as rifampin, carbamazepine, St. John’s wort, or long acting barbiturates with CRESEMBA is contraindicated because strong CYP3A4 inducers can significantly decrease the plasma concentration of isavuconazole [see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )]. |
| Cyclosporine | drug interactions | Cyclosporine Use with Caution Concomitant administration of CRESEMBA and cyclosporine results in increase in cyclosporine exposure. |
| Digoxin | drug interactions | Digoxin Use with Caution Concomitant administration of CRESEMBA and digoxin results in increase in digoxin exposure. |
| Ketoconazole | contraindications | Coadministration of strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir (400 mg every 12 hours), with CRESEMBA is contraindicated because strong CYP3A4 inhibitors can significantly increase the plasma concentration of isavuconazole [see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )]. |
| Lopinavir and ritonavir | drug interactions | Caution is advised when CRESEMBA is coadministered with lopinavir/ritonavir There is a 96% increase in exposure of isavuconazole when coadministered with lopinavir/ritonavir [see Clinical Pharmacology ( 12.3 )]. |
| Midazolam | drug interactions | Midazolam Use with Caution Concomitant administration of CRESEMBA and midazolam results in increase in midazolam exposure. |
| Mycophenolate mofetil | drug interactions | Mycophenolate Mofetil Use with Caution Concomitant administration of CRESEMBA and MMF results in increase in MMF exposure. |
| Rifampin | contraindications | Coadministration of strong CYP3A4 inducers, such as rifampin, carbamazepine, St. John’s wort, or long acting barbiturates with CRESEMBA is contraindicated because strong CYP3A4 inducers can significantly decrease the plasma concentration of isavuconazole [see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )]. |
| Ritonavir | contraindications | Coadministration of strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir (400 mg every 12 hours), with CRESEMBA is contraindicated because strong CYP3A4 inhibitors can significantly increase the plasma concentration of isavuconazole [see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )]. |
| Sirolimus | drug interactions | Sirolimus Use with Caution Concomitant administration of CRESEMBA and sirolimus results in increase in sirolimus exposure. |
| Tacrolimus | drug interactions | Tacrolimus Use with Caution Concomitant administration of CRESEMBA and tacrolimus results in increase in tacrolimus exposure. |
| Vincristine | drug interactions | Vincristine Avoid Concomitant Use Avoid concomitant use with CRESEMBA in pediatric and adult patients. |
Other labels that name isavuconazonium
Source: FDA drug label (CRESEMBA), Astellas Pharma US, Inc., effective April 25, 2025 (SPL set 8f7f73b8-586a-4df0-935f-fecd4696c16c), via openFDA; the full label on DailyMed
What do FAERS reports show for isavuconazonium?
The FDA Adverse Event Reporting System holds 3,649 reports that list isavuconazonium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 739 are coded as a death and 1,183 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to isavuconazonium
- medicines labeled for the same conditions
- Other azole antifungals
- the pharmacologic class, with prices and generics
- Isavuconazonium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other