Generic Name and Formulations:
Isavuconazonium sulfate 186mg; caps.
Astellas Pharma US, Inc.
Indications for CRESEMBA:
Invasive aspergillosis. Invasive mucormycosis.
Swallow whole. ≥18yrs: loading dose: 372mg every 8hrs for 6 doses (48hrs); maintenance dose: 372mg once daily starting 12–24hrs after the last loading dose.
<18yrs: not established.
Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, high-dose ritonavir [400mg every 12hrs]). Concomitant strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John's wort, long-acting barbiturates). Familial short QT syndrome.
Perform liver-related lab tests at the start of and during therapy; monitor for more severe hepatic injury if abnormal test results. Discontinue if liver disease, infusion-related reactions (including hypotension, dyspnea, chills, dizziness, paresthesia, hypoesthesia), or severe cutaneous reactions develop. Azole hypersensitivity. Severe hepatic impairment (Child-Pugh Class C). Pregnancy (Cat.C); avoid. Nursing mothers: not recommended.
See Contraindications. Caution with concomitant lopinavir/ritonavir, atorvastatin (monitor), midazolam (consider dose reduction), bupropion (consider dose increase), mycophenolate mofetil (monitor for MPA-related toxicities), digoxin (monitor). Concomitant cyclosporine, sirolimus, tacrolimus; monitor and adjust dose as needed.
Nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, back pain.
Blister packs—7; Single-use vials—1