Isavuconazole

Triazole antifungal for the treatment of invasive aspergillosis or mucorycosis in patients in whom, treatment with amphotericin B is not appropriate. Isavuconazole can be considered a moderate inhibitor of CYP3A4/5 and systemic exposure to drugs metabolized by CYP3A4 may be increased when used concomitantly with isavuconazole.

Saturation dose: two capsules (equivalent to 200 mg isavuconazole) every 8 hours for the first 48 hours (6 applications in total). Maintenance dose: two capsules (equivalent to 200 mg of isavuconazole) once a day. Start taking 12 to 24 hours after the last saturation dose. For long term treatments lasting more than 6 months, careful consideration should be given to the risk-benefit ratio

No dose adjustment is required for mild to moderate kidney dysfunction and liver dysfunction(Child Pugh Classification A and B).

Children and adolescents: The safety and efficacy of isavuconazole in children under 18 years of age is not proven. No data are available.

Hypersensitivity to the active substance; simultaneous use with ketoconazole, simultaneous use with high-dose ritonavir (> 200 mg every 12 hours; simultaneous use with strong CYP3A4/5 inducers (e.g. (e.g. rifampicin, rifabutin, carbamazepine, long-acting barbiturates such as phenobarbital), phenytoin and St. John's wort, and with moderately potent CYP3A4/5 inducers such as efavirenz, nafcillin and etravirin. Patients with familial short QT syndrome.

hypotension, respiratory insufficiency, dyspnoea, drug exanthema and pruritus occur. Stevens-Johnson syndrome has been reported during treatment with azole antifungals. Cardiovascular effects: shortening of the QT interval

The most common treatment-related adverse events were elevated values in liver chemistry tests (7.9%), nausea (7.4%), vomiting (5.5%), dyspnea (3.2%), abdominal pain (2.7%), diarrhea (2.7%), headache (2.0%), hypokalemia (1.7%) and exanthema (1.7%).

Isavuconazole is contraindicated in patients with familial short QT syndrome. Caution is therefore advised for patients taking other drugs that shorten the QT interval (such as rufinamide).

Elevated liver transaminases or hepatitis: elevated liver transaminases may occur.

Concurrent use with other drugs

CYP3A4/5 inhibitors such as ketoconazole are contraindicated.

CRESEMBA 100 mg hard capsules