Basilea reports U.S. FDA approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis - Seite 3

The following information about isavuconazole is applicable only to the product approved in the United States:

The recommended loading dose of CRESEMBA^® is one reconstituted vial or two capsules (372 mg isavuconazonium sulfate equivalent to 200 mg of isavuconazole) every eight hours for six doses (48 hours) via oral or intravenous administration. The recommended maintenance dose is one reconstituted vial or two capsules (372 mg isavuconazonium sulfate equivalent to 200 mg of isavuconazole) once per day via oral or intravenous administration, starting 12 to 24 hours after the last loading dose. Capsules can be taken with or without food. CRESEMBA^® for injection must be administered through an in-line filter over a minimum of one hour.

Important Safety Information for CRESEMBA^® (isavuconazonium sulfate)

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. CRESEMBA^® is contraindicated in patients with familial short QT syndrome.

Hepatic Adverse Drug Reactions (e.g., elevations in ALT, AST, alkaline phosphatase, total bilirubin) have been reported in clinical trials and were generally reversible and did not require discontinuation of CRESEMBA^®. Cases of severe hepatic adverse drug reactions including hepatitis, cholestasis or hepatic failure including death have been reported in patients with serious underlying medical conditions (e.g., hematologic malignancy) during treatment with azole antifungal agents, including CRESEMBA^®. Evaluate liver tests at the start and during therapy. Monitor patients who develop liver abnormalities during CRESEMBA therapy for severe hepatic injury. Discontinue if clinical signs and symptoms consistent with liver disease develop that may be attributable to CRESEMBA^®.