isavuconazole
Cresemba · ATC code J02AC05
Also known as: Isavuconazol, İsavukonazol
- Key facts
- Active substance
- isavuconazole
- ATC code
- J02AC05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- CRESEMBA 200 mg powder for concentrate for solution for infusion · CRESEMBA 40 mg hard capsules / CRESEMBA 100 mg hard capsules
- Marketing authorisation holder
- Basilea Pharmaceutica Deutschland GmbH
- Information as of
- 2026-10-29
Key facts
Isavuconazole (Cresemba) is an azole antifungal used to treat invasive aspergillosis and mucormycosis when amphotericin B is inappropriate.
What it is used for
- Invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.
- Infusion from 1 year of age; hard capsules in adults and children from 6 years of age (40 mg capsules intended for children).
Dosing
- Infusion, adults: loading 200 mg (one vial) every 8 hours for the first 48 hours (six administrations), then 200 mg once daily, starting 12 to 24 hours after the last loading dose.
- Infusion, children aged 1 to less than 18 years: ≥ 37 kg as for adults; < 37 kg 5.4 mg/kg for loading and maintenance; maximum single dose 200 mg.
- Capsules, adults: two 100 mg capsules every 8 hours on Days 1 and 2, then two 100 mg capsules once daily. Children from 6 years: number of capsules by body weight (see the full text).
- Given the high oral bioavailability (98%), switching between intravenous and oral use is appropriate. Treatment beyond 6 months requires careful benefit-risk consideration.
- Adults: no adjustment in renal impairment or mild to moderate hepatic impairment; not recommended in Child-Pugh C unless the benefit outweighs the risks.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Co-administration with ketoconazole or high-dose ritonavir (>200 mg every 12 hours).
- Co-administration with strong CYP3A4/5 inducers (e.g. rifampicin, rifabutin, carbamazepine, long-acting barbiturates, phenytoin, St John's wort) or moderate inducers (efavirenz, nafcillin, etravirine).
- Familial short QT syndrome.
Important warnings
- Hypersensitivity reactions up to anaphylaxis; caution with hypersensitivity to other azoles.
- Infusion-related reactions (hypotension, dyspnoea, dizziness, paraesthesia) – stop the infusion.
- Severe cutaneous reactions such as Stevens-Johnson syndrome – discontinue.
- Concentration-related QTc shortening; caution with other QT-shortening medicines (e.g. rufinamide).
- Elevated liver transaminases or hepatitis may occur; monitor liver function.
Side effects
- Most common treatment-related reactions in adults: elevated liver chemistry tests (7.9%), nausea (7.4%), vomiting (5.5%), dyspnoea (3.2%), abdominal pain (2.7%), diarrhoea (2.7%), injection site reaction (2.2%), headache (2.0%), hypokalaemia (1.7%) and rash (1.7%).
- Reactions most often leading to discontinuation: confusional state, acute renal failure, increased bilirubin, convulsion and respiratory failure.
Interactions
- Isavuconazole is a CYP3A4/5 substrate: inhibitors increase and inducers decrease its levels (see contraindications).
- For interactions with many other medicines see the full text.
Pregnancy and breastfeeding
- Must not be used in pregnancy except for severe or potentially life-threatening fungal infections when benefits outweigh risks; not recommended in women of childbearing potential not using contraception.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- CresembaBasilea Pharmaceutica Deutschland GmbH · EMEA/H/C/002734
Source: European Medicines Agency (EMA), product information
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Cresemba – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/cresemba-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.