CRESEMBA

Cresemba Generic Name & Formulations

Legal Class

General Description

Isavuconazonium sulfate 186mg; caps.

Pharmacological Class

Azole antifungal.

How Supplied

Blister packs—14, 56; Single-dose vials—1, 10

Manufacturer

Astellas Pharma US, Inc.

Generic Availability

Cresemba Indications

Indications

Invasive aspergillosis. Invasive mucormycosis.

Cresemba Dosage and Administration

Adult

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.

Children

<18yrs: not established.

Cresemba Contraindications

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.

Cresemba Boxed Warnings

Not Applicable

Cresemba Warnings/Precautions

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), anaphylactic, or severe cutaneous reactions (eg, Stevens-Johnson syndrome) develop. Azole hypersensitivity (monitor). Severe hepatic impairment (Child-Pugh Class C). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 28 days after the last dose. Pregnancy. Nursing mothers: not recommended.

Cresemba Pharmacokinetics

Metabolism

>99% plasma protein bound.

Elimination

Oral admin: fecal (46.1%), renal (45.5%). Half-life: 130 hours.

Cresemba Interactions

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.

Cresemba Adverse Reactions

Adverse Reactions

Nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, back pain; infusion-related reactions, hypersensitivity reactions.

Cresemba Clinical Trials

See Literature

Cresemba Note