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Cresemba

Cresemba

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Isavuconazole
Indications/Uses
Invasive aspergillosis. Mucormycosis in patients for whom amphotericin B is inappropriate.
Dosage/Direction for Use
Cap Loading dose: 2 cap (equiv to 200 mg) every 8 hr for 1st 48 hr (total administrations: 6). Maintenance dose: 2 cap (equiv to 200 mg) once daily, starting 12-24 hr after the last loading dose. IV infusion Loading dose: 1 vial every 8 hr for 1st 48 hr (total administrations: 6). Maintenance dose: 1 vial once daily, starting 12-24 hr after the last loading dose.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/dissolve/open cap.
Contraindications
Hypersensitivity. Concomitant use w/ ketoconazole, high-dose ritonavir, 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. Patients w/ familial short QT syndrome.
Special Precautions
Hypersensitivity to other azole antifungals. Discontinue use if patient develop severe cutaneous adverse reaction eg, Stevens-Johnson syndrome; infusion-related reactions (for infusion only). Monitor hepatic enzymes due to elevated liver transaminases or hepatitis. Concomitant use w/ drugs known to decrease QT interval eg, rufinamide; strong CYP3A4/5 inhibitors eg, lopinavir/ritonavir; CYP3A4/5 inducers eg, aprepitant, prednisolone & pioglitazone; CYP3A4 substrates eg, immunosuppresants, tacrolimus, sirolimus or ciclosporin; CYP2B6 substrates especially drugs w/ narrow therapeutic index eg, cyclophosphamide; P-gp substrates especially drugs w/ narrow therapeutic index eg, digoxin, colchicine, dabigatran etexilate. CYP3A4/5 inhibitors eg, lopinavir/ritonavir; CYP3A4/5 inducers eg, aprepitant, prednisolone & pioglitazone; CYP3A4 substrates eg, immunosuppresants, tacrolimus, sirolimus or ciclosporin; CYP2B6 substrates especially drugs w/ narrow therapeutic index eg, cyclophosphamide; P-gp substrates especially drugs w/ narrow therapeutic index eg, digoxin, colchicine, dabigatran etexilate. Moderate potential to influence the ability to drive & use machines. Not recommended for patients w/ severe hepatic impairment; women of childbearing potential or not using contraception. Pregnancy & lactation (discontinue).
Adverse Reactions
Hypokalemia, decreased appetite; delirium; headache, somnolence; thrombophlebitis; dyspnea, acute resp failure; vomiting, diarrhea, nausea, abdominal pain; elevated liver chemistry test; rash, pruritus; renal failure; chest pain, fatigue, inj site reaction. 
Drug Interactions
May decrease conc w/ strong CYP3A4/5 inducers eg, carbamazepine, phenobarb, phenytoin, rifampicin, rifabutin, nafcillin, St. John's wort; prednisone; ritonavir (at high doses); etravirine; pioglitazone. May increase conc w/ strong CYP3A4/5 inhibitors eg, clarithromycin, ketoconazole; indinavir; other PIs (eg, amprenavir, nelfinavir). May increase conc of short-acting opiates eg, alfentanyl, fentanyl; vinca alkaloids eg, vincristine, vinblastine; daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan, dabigatran etexilate; atorvastatin & other statins (eg, simvastatin, lovastatin, rosuvastatin); colchicine. May decrease conc of cyclophosphamide, aprepitant, efavirenz, saquinavir. May decrease AUC & Cmax of lopinavir/ritonavir. May decrease or increase conc of other NNRTIs (eg, delavirdine & nevirapine).
MIMS Class
ATC Classification
J02AC05 - isavuconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Cresemba hard cap 100 mg
Packing/Price
14's
Form
Cresemba powd for infusion 200 mg
Packing/Price
10 mL x 1's
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