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Cresemba

Cresemba

isavuconazole

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
Recommended loading dose: 200 mg every 8 hr for 1st 48 hr. Maintenance dose: 200 mg once daily starting 12-24 hr after last loading dose.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/dissolve/open cap.
Contraindications
Hypersensitivity. Patients w/ familial short QT syndrome. Co-administration w/ ketoconazole, high-dose ritonavir (>200 mg bd), strong CYP3A4/5 [eg, rifampicin, rifabutin, carbamazepine, long-acting barbiturates (eg, phenobarb), phenytoin, St. John's wort] or moderate CYP3A4/5 (eg, efavirenz, nafcillin, etravirine) inducers.
Special Precautions
Hypersensitivity to other azole antifungals. Discontinue use if severe cutaneous ARs eg, Stevens-Johnson syndrome develops. Hepatitis. Long-term use. Monitor hepatic enzymes as clinically indicated. Avoid co-administration w/ mild CYP3A4/5 inducers eg, aprepitant, prednisone, pioglitazone. Concomitant use w/ other medicinal products decreasing QT interval eg, rufinamide; strong CYP3A4/5 inhibitors; CYP3A4 substrates eg, tacrolimus, sirolimus or ciclosporin; CYP2B6 substrates eg, cyclophosphamide; P-gp substrates eg, digoxin, colchicine, dabigatran etexilate. May affect ability to drive & use machines. Not recommended in severe hepatic impairment (Child-Pugh C). Not recommended in women of childbearing potential not using contraception. Not to be used during pregnancy & lactation. Childn <18 yr. Elderly. Infusion: Discontinue use if infusion-related reactions occur. Not to be infused into same line or cannula concomitantly w/ other IV products.
Adverse Reactions
Hypokalaemia, decreased appetite; delirium; headache, somnolence; thrombophlebitis; dyspnoea, acute resp failure; vomiting, diarrhoea, nausea, abdominal pain; elevated liver chemistry tests; rash, pruritus; renal failure; chest pain, fatigue. Infusion: Inj site reaction.
Drug Interactions
Increased plasma conc w/ CYP3A4/5 inhibitors eg, ketoconazole, lopinavir/ritonavir, clarithromycin, indinavir, saquinavir, amprenavir, nelfinavir; esomeprazole. Decreased plasma conc w/ CYP3A4/5 inducers eg, rifampicin, rifabutin, carbamazepine, phenobarb, phenytoin, St. John's wort, efavirenz, nafcillin, etravirine, aprepitant, prednisone, pioglitazone, high-dose ritonavir (>200 mg bd). Increased plasma conc of CYP3A4/5 (eg, ciclosporin, sirolimus, tacrolimus, prednisone, short-acting opiates, statins, ethinyl oestradiol, norethindrone, midazolam), P-gp (eg, vinca alkaloids, dabigatran etexilate, digoxin, colchicine), BCRP (eg, methotrexate, daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan), OCT2 (eg, metformin) & UGT (eg, mycophenolate mofetil) substrates; dextromethorphan. Decreased plasma conc of CYP2B6 (eg, cyclophosphamide, delavirdine, nevaripine, bupropion) & CYP2C8 (eg, repaglinide) substrates; omeprazole.
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 infusion conc 200 mg
Packing/Price
1's
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