Generic Name: isavuconazonium sulfate
Date of Approval: March 6, 2015
Company: Astellas Pharma US, Inc.
CRESEMBA for INJECTION Rx
Generic Name and Formulations:
Isavuconazonium sulfate 372mg; lyophilized pwd for IV inj after reconstitution; preservative-free.
Company:
Astellas Pharma US, Inc.
Indications for CRESEMBA for INJECTION:
Invasive aspergillosis. Invasive mucormycosis.
Adult:
Infuse over a minimum of 1hr. ≥18yrs: loading dose: 372mg every 8hrs for 6 doses (48hrs); maintenance dose: 372mg once daily starting 12−24hrs after the last loading dose.
Children:
<18yrs: not established.
See Also:
CRESEMBA
Pharmacological Class:
Azole antifungal.
Contraindications:
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.
Warnings/Precautions:
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.
Interactions:
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.
Adverse Reactions:
Nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, back pain.
Generic Availability:
NO
How Supplied:
Blister packs—7; Single-use vials—1
