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CRESEMBA for INJECTION
Fungal infections
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Drug Name:

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.

Therapeutic Use:

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.

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.

See Also:

CRESEMBA

Pharmacological Class:

Azole antifungal.

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

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