Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Basilea Pharmaceutica Deutschland GmbH, Marie-Curie-Strasse 8, 79539, Lörrach, Germany
CRESEMBA is indicated in adults for the treatment of:
Consideration should be given to official guidance on the appropriate use of antifungal agents.
The recommended loading dose is two capsules (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total).
The recommended maintenance dose is two capsules (equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose.
Duration of therapy should be determined by the clinical response (see section 5.1).
For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered (see sections 5.1 and 5.3).
CRESEMBA is also available as powder for concentrate for solution for infusion containing 200 mg isavuconazole, equivalent to 372 mg isavuconazonium sulfate.
On the basis of the high oral bioavailability (98%, see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
No dose adjustment is necessary for elderly patients; however the clinical experience in elderly patients is limited.
No dose adjustment is necessary in patients with renal impairment, including patients with end-stage renal disease (see section 5.2).
No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B) (see sections 4.4 and 5.2).
CRESEMBA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Use in these patients is not recommended unless the potential benefit is considered to outweigh the risks. See sections 4.4, 4.8 and 5.2.
The safety and efficacy of CRESEMBA in children aged below 18 years has not yet been established.
No data are available.
CRESEMBA capsules can be taken with or without food.
CRESEMBA capsules should be swallowed whole. Do not chew, crush, dissolve or open the capsules.
Symptoms reported more frequently at supratherapeutic doses of CRESEMBA (equivalent to isavuconazole 600 mg/day) evaluated in a QT study than in the therapeutic dose group (equivalent to isavuconazole 200 mg/day dose) included: headache, dizziness, paraesthesia, somnolence, disturbance in attention, dysgeusia, dry mouth, diarrhoea, oral hypoaesthesia, vomiting, hot flush, anxiety, restlessness, palpitations, tachycardia, photophobia and arthralgia
Isavuconazole is not removed by haemodialysis. There is no specific antidote for isavuconazole. In the event of an overdose, supportive treatment should be instituted.
Shelf life: 30 months.
Do not store above 30°C.
Store in the original packaging in order to protect from moisture.
14 hard capsules (in two aluminum blisters), with each capsule pocket connected to a pocket with desiccant.
This medicinal product may pose a risk to the environment (see section 5.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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