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Hypersensitivity to the active substance or to any of the excipients listed in the Local Product Document
Co-administration with ketoconazole, high-dose ritonavir (>200 mg every 12 hours), strong CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital), phenytoin and St. John’s wort, or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine
Patients with familial short QT syndrome
Hypersensitivity to isavuconazole may result in adverse reactions that include:
hypotension, respiratory failure, dyspnoea, drug eruption, pruritus and rash. Prescribe with caution in patients with hypersensitivity to other azole antifungal agents
Infusion-related reactions including hypotension, dyspnoea, dizziness, paraesthesia, nausea and headache have been reported. The infusion should be stopped if these reactions occur
Severe cutaneous adverse reactions such as Stevens-Johnson syndrome have been reported during treatment with azole antifungal agents. If a patient develops a severe cutaneous adverse reaction, CRESEMBA® should be discontinued
CRESEMBA® is contraindicated in patients with familial short QT syndrome. Caution is warranted when prescribing CRESEMBA® to patients taking medicinal products, such as rufinamide, known to decrease the QT interval
Elevated liver transaminases have been reported in clinical studies and rarely required discontinuation of CRESEMBA®. Monitoring of hepatic enzymes should be considered, as clinically indicated. Hepatitis has been reported with azole antifungal agents including CRESEMBA®
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. Patients should be carefully monitored for potential drug toxicity
AE, adverse event; CYP, cytochrome P.
Prescribing Information:
CRESEMBA® (isavuconazole)
Reference:
PP-CRB-IND-0472 July 2022
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