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Cresemba For Injection Generic Name & Formulations
Legal Class
Rx
General Description
Isavuconazonium sulfate 372mg; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
Azole antifungal.
See Also
How Supplied
Blister packs—14, 56; Single-dose vials—1, 10
Manufacturer
Generic Availability
NO
Cresemba For Injection Indications
Indications
Invasive aspergillosis. Invasive mucormycosis.
Cresemba For Injection Dosage and Administration
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.
Cresemba For Injection 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 For Injection Boxed Warnings
Not Applicable
Cresemba For Injection 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 For Injection Pharmacokinetics
Elimination
Oral admin: fecal (46.1%), renal (45.5%). Half-life: 130 hours.
Cresemba For Injection 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 For Injection 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 For Injection Clinical Trials
See Literature
Cresemba For Injection Note
Not Applicable
Cresemba For Injection Patient Counseling
See Literature
