Isavuconazonium

What it is used for

CRESEMBA ® is an azole antifungal indicated for the treatment of: Invasive aspergillosis and Invasive mucormycosis as follows: CRESEMBA for injection: adults and pediatric patients 1 year of age and older CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater 1.1 Invasive Aspergillosis CRESEMBA ® is indicated for the treatment of invasive aspergillosis as follows: CRESEMBA for injection: adults and pediatric patients 1 year of age and older CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater 1.2 Invasive Mucormycosis CRESEMBA is indicated for the treatment of invasive mucormycosis as follows: CRESEMBA for injection: adults and pediatric patients 1 year of age and older CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kg and greater, Clinical Studies and Clinical Pharmacology ( 12.3, 12.4 )] 1.3 Usage Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy.

Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

Side effects, and when to stop

The following are discussed in more detail in other sections of the labeling:

• Hepatic Adverse Drug Reactions
• Infusion-Related Reactions
• Hypersensitivity Reactions
• Embryo-Fetal Toxicity

Who should not take it

• 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.

Other medicines and interactions

Isavuconazole is a sensitive substrate of CYP3A4. CYP3A4 inhibitors or inducers may alter the plasma concentrations of isavuconazole.

Isavuconazole is a moderate inhibitor of CYP3A4, and a mild inhibitor of P-glycoprotein (P-gp), and organic cation transporter 2 (OCT2).

Drug interaction studies were conducted to investigate the effect of coadministered drugs on the pharmacokinetics of isavuconazole and the effect of isavuconazole on the pharmacokinetics of coadministered drugs.