Cresemba

Invasive aspergillosis in adults. Mucormycosis in patients for whom amphotericin B is inappropriate.

Oral/IV Adult Loading dose: 200 mg every 8 hr for the 1st 48 hr. Maintenance dose: 200 mg once daily, starting 12-24 hr after last loading dose.

Hard cap: May be taken with or without food: Swallow whole, do not chew/crush/dissolve/open.

Hypersensitivity. Co-administration 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]; moderate CYP3A4/5 inducers (eg, efavirenz, nafcillin & etravirine). Familial short QT syndrome.

Hypersensitivity to isavuconazole may result in anaphylactic reaction, hypotension, resp failure, dyspnoea, drug eruption, pruritus & rash; other azole antifungals. Discontinue use if severe cutaneous adverse reactions (eg, SJS) develop. Patients concomitantly taking other medicinal products known to decrease QT interval (eg, rufinamide). Possible elevated liver transaminases; consider monitoring of hepatic enzymes. Risk of hepatitis. Concomitant use w/ CYP3A4/5 inhibitors (eg, ketoconazole, lopinavir/ritonavir), inducers (eg, aprepitant, prednisone, pioglitazone) & substrates including immunosuppressants (eg, tacrolimus, sirolimus, ciclosporin); CYP2B6 substrates (eg, cyclophosphamide, efavirenz); P-gp substrates (eg, digoxin, colchicine, dabigatran etexilate). No dose-finding study in mucormycosis; patients were administered w/ same dose as used for invasive aspergillosis. Avoid driving or operating machinery if symptoms of confusional state, somnolence, syncope &/or dizziness are experienced. Carefully monitor for potential drug toxicity in patients w/ severe hepatic impairment (Child-Pugh class C). Not recommended for women of childbearing potential not using contraception. Do not use during pregnancy. Discontinue breast-feeding during treatment. Childn <18 yr. Elderly. IV: Discontinue use if infusion-related reactions including hypotension, dyspnoea, dizziness, paraesthesia, nausea & headache occur.

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. IV: Inj site reaction.

May increase plasma conc w/ CYP3A4 &/or CYP3A5 inhibitors. May decrease plasma conc w/ CYP3A4 &/or CYP3A5 inducers. Significantly increased plasma conc by ketoconazole. 2-fold increase in exposure w/ lopinavir/ritonavir. Significantly decreased plasma conc w/ potent CYP3A4/5 inducers [eg, rifampicin, rifabutin, carbamazepine, long-acting barbiturates (eg, phenobarb), phenytoin & St. John's wort]; moderate CYP3A4/5 inducers (eg, efavirenz, nafcillin & etravirine). May mildly to moderately decrease plasma levels w/ mild CYP3A4/5 inducers (eg, aprepitant, prednisone & pioglitazone). May induce CYP3A4/5 & decrease isavuconazole plasma conc w/ high-dose ritonavir (>200 mg bd). May increase plasma conc of CYP3A4/5, P-gp, BCRP & OCT2 substrates. May decrease plasma conc of CYP2B6 substrates. May mildly increase plasma conc of UGT substrates.

Antifungals

J02AC05 - isavuconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.

POM