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Cresemba

Cresemba

isavuconazole

Manufacturer:

Pfizer

Distributor:

Pfizer
Concise Prescribing Info
Contents
Isavuconazonium sulfate
Indications/Uses
Invasive aspergillosis; mucormycosis in patients for whom amphotericin B is inappropriate.
Dosage/Direction for Use
Adult Cap Recommended loading dose: 2 cap (equiv to 200 mg isavuconazole) every 8 hr for the 1st 48 hr (total: 6 administrations). Recommended maintenance dose: 2 cap (equiv to 200 mg isavuconazole) once daily, starting 12-24 hr after the last loading dose. Powd for infusion Must be reconstituted & then further diluted to conc corresponding to approx 0.8 mg/mL isavuconazole prior to administration by IV infusion over min of 1 hr. Recommended loading dose: 1 vial after reconstitution & dilution (equiv to 200 mg isavuconazole) every 8 hr for the 1st 48 hr (total: 6 administrations). Recommended maintenance dose: 1 vial after reconstitution & dilution (equiv to 200 mg isavuconazole) once daily, starting 12-24 hr after the last loading dose.
Administration
Cap: May be taken with or without food: Do not chew/crush/dissolve/open the cap. Swallow whole.
Contraindications
Hypersensitivity. Patients w/ familial short QT syndrome. Concomitant use w/ ketoconazole, high-dose ritonavir (>200 mg every 12 hr), strong CYP3A4/5 inducers eg, rifampicin, rifabutin, carbamazepine, long-acting barbiturates (eg, phenobarb), phenytoin & St. John's wort or w/ moderate CYP3A4/5 inducers eg, efavirenz, nafcillin & etravirine.
Special Precautions
Hypersensitivity may occur; discontinue immediately in case of anaphylactic reaction. Caution in patients w/ hypersensitivity to other azole antifungal agents. Reports of severe cutaneous adverse reactions eg, SJS; discontinue therapy if patient develops severe cutaneous adverse reaction. Risk of QT shortening; caution to patients taking other medicinal products known to decrease QT interval eg, rufinamide. Caution w/ concomitant CYP3A4/5 inhibitors eg, lopinavir/ritonavir (except for ketoconazole to which co-administration is contraindicated); CYP2B6 substrates, especially medicinal products w/ narrow therapeutic index eg, cyclophosphamide. Avoid concomitant use w/ mild CYP3A4/5 inducers eg, aprepitant, prednisone, pioglitazone. Appropriate therapeutic drug monitoring & dose adjustment may be necessary in concomitant use w/ CYP3A4 substrates eg, tacrolimus, sirolimus or ciclosporin. Dose adjustment of P-gp substrates may be needed, especially w/ narrow therapeutic index eg, digoxin, colchicine & dabigatran etexilate. Limited clinical data in the treatment of mucormycosis. Moderate potential to influence ability to drive & use machines. Monitor hepatic enzymes; elevated liver transaminases have been reported. Not recommended in patients w/ severe hepatic impairment (Child-Pugh Class C) unless potential benefit outweighs risks. Must not be used during pregnancy except in patients w/ severe or potentially life-threatening fungal infections, in whom isavuconazole may be used if the anticipated benefits outweigh possible risks to the fetus. Not recommended for women of childbearing potential who are not using contraception. Discontinue breast-feeding during therapy. Safety & efficacy in childn <18 yr have not been established. Limited clinical experience in elderly. Powd for infusion: Infusion-related reactions including hypotension, dyspnea, dizziness, paresthesia, nausea & headache were reported; stop infusion if these reactions occur.
Adverse Reactions
Elevated liver chemistry tests, nausea, vomiting, dyspnea, abdominal pain, diarrhea, inj site reaction, headache, hypokalemia, rash. Decreased appetite; delirium; somnolence; thrombophlebitis; acute resp failure; pruritus; renal failure; chest pain, fatigue.
Drug Interactions
Significantly increased plasma conc w/ strong CYP3A4/5 inhibitor ketoconazole. Increased isavuconazole exposure w/ strong CYP3A4 inhibitor lopinavir/ritonavir; less pronounced effect can be expected w/ other strong CYP3A4 inhibitors eg, clarithromycin, indinavir & saquinavir. Decreased plasma conc w/ potent CYP3A4/5 inducers eg, rifampicin, rifabutin, carbamazepine, long-acting barbiturates (eg, phenobarb), phenytoin & St. John's wort, or w/ moderate CYP3A4/5 inducers eg, efavirenz, nafcillin & etravirine; high-dose ritonavir (>200 mg bid). Mild to moderate decrease of plasma levels w/ mild CYP3A4/5 inducers eg, aprepitant, prednisone & pioglitazone. Increased plasma conc of CYP3A4/5, P-gp, BCRP, OCT2 substrates. Decreased plasma conc of CYP2B6 substrates. Mildly increased plasma conc of uridine diphosphate-glucuronosyltransferases (UGT) substrates.
MIMS Class
Antifungals
ATC Classification
J02AC - Triazole and tetrazole derivatives ; Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Cresemba cap 186.3 mg
Packing/Price
14's
Form
Cresemba lyo powd for conc for soln for IV infusion 372.6 mg
Packing/Price
1's
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