Molecule
Isavuconazonium is an azole antifungal indicated for the treatment of invasive aspergillosis and Invasive mucormycosis, among other approved uses. It is available as capsules and powder for injection for oral and intravenous use. MedsAcross supplies Isavuconazonium for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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
Source: US FDA prescribing information
Isavuconazonium sulfate is the prodrug of isavuconazole, an azole antifungal.
Source: US FDA prescribing information
Important Administration Instructions: • CRESEMBA for injection is intended for use in patients who are 1 year of age and older. • CRESEMBA for injection via nasogastric (NG) tube administration is intended for use by patients who are 6 years of age and older and weighing 16 kg and greater. • CRESEMBA for injection must be administered through an in-line filter over a minimum of 1 hour. • CRESEMBA capsules are intended for use in patients who are 6 years of age and older and weighing 16 kg and greater. • CRESEMBA capsules can be taken with or without food. Recommended Dosage in Adult Patients: Recommended Dosage for CRESEMBA in Adult Patients.
Source: US FDA prescribing information
• CRESEMBA is contraindicated in persons with known hypersensitivity to isavuconazole. • 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. • 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. • CRESEMBA shortened the QTc interval in a concentration-related manner.
Source: US FDA prescribing information
• Hepatic Adverse Drug Reactions: Serious hepatic reactions have been reported. Evaluate liver-related laboratory tests at the start and during the course of CRESEMBA therapy. • Infusion-related reactions were reported during intravenous administration of CRESEMBA. Discontinue the infusion if these reactions occur. • Hypersensitivity Reactions: Anaphylactic reactions, with fatal outcome, have been reported during treatment with CRESEMBA. Serious skin reactions, such as Stevens-Johnson syndrome, have been reported during treatment with other azole antifungal agents. Discontinue CRESEMBA if anaphylactic or serious skin reactions occur, and initiate supportive treatment as needed. • Embryo-Fetal Toxicity: CRESEMBA may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus.
Source: US FDA prescribing information
The following are discussed in more detail in other sections of the labeling: • Hepatic Adverse Drug Reactions • Infusion-Related Reactions • Hypersensitivity Reactions • Embryo-Fetal Toxicity • Adult Patients: The most frequent adverse reactions in adult patients were nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, and back pain. • Pediatric Patients: The most frequent adverse reactions in pediatric patients were diarrhea, abdominal pain, vomiting, elevated liver chemistry tests, rash, nausea, pruritus, and headache.
Source: US FDA prescribing information
Isavuconazole is a sensitive substrate of CYP3A4. CYP3A4 inhibitors or inducers may alter the plasma concentrations of isavuconazole. Isavuconazole is a moderate inhibitor of CYP3A4, and a mild inhibitor of P-glycoprotein (P-gp), and organic cation transporter 2 (OCT2). Drug interaction studies were conducted to investigate the effect of coadministered drugs on the pharmacokinetics of isavuconazole and the effect of isavuconazole on the pharmacokinetics of coadministered drugs. Table 4. Drug(s) Affecting Pharmacokinetics of CRESEMBA Recommendation Comments Ketoconazole Contraindicate coadministration of all potent CYP3A4 inhibitors There is more than a 5-fold increase in exposure of isavuconazole upon coadministration with ketoconazole. Lopinavir/ritonavir 400 mg of lopinavir in combination with 100 mg of ritonavir.
Source: US FDA prescribing information
CRESEMBA Capsules Store CRESEMBA capsules at 20°C to 25°C (68°F to 77°F) in the original packaging to protect from moisture. Excursions are permitted from 15°C to 30°C (59°F to 86°F). The prepared infusion solution should be kept for not more than 6 hours at room temperature [20°C to 25°C (68°F to 77°F)] or 24 hours at 2°C to 8°C (36°F to 46°F) prior to use. CRESEMBA for Injection Store CRESEMBA for injection unreconstituted vials at 2°C to 8°C (36°F to 46°F) in a refrigerator.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Isavuconazonium, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Cresemba 100 mg capsuleOral | Astellas Pharma | US FDA | Available on request |
| Cresemba 40 mg capsuleOral | Astellas Pharma | US FDA | Available on request |
| Cresemba 40 mg/mL powder for injectionIntravenous | Astellas Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 6 March 2015 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 3 presentations of Isavuconazonium and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Isavuconazonium, including Cresemba.
Yes. The US FDA first approved Isavuconazonium on 6 March 2015, according to Drugs@FDA.
No listed presentation of Isavuconazonium is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.