Cresemba

Cresemba

isavuconazole

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Isavuconazole
Indications/Uses
Invasive aspergillosis in adults. Mucormycosis in adults for whom amphotericin B is inappropriate.
Dosage/Direction for Use
PO/IV Recommended loading dose: 200 mg every 8 hr for the 1st 48 hr. Maintenance: 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 the capsule.
Contraindications
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] or w/ moderate CYP3A4/5 inducers (eg, efavirenz, nafcillin & etravirine). Familial short QT syndrome.
Special Precautions
Hypersensitivity to isavuconazole may result in anaphylactic reaction, hypotension, resp failure, dyspnoea, drug eruption, pruritus & rash; other azole antifungals. Discontinue use if severe cutaneous AR (eg, SJS) develops. Patients concomitantly taking other medicinal products known to decrease QT interval (eg, rufinamide). 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); 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. 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.
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, inj site reaction (IV only).
Drug Interactions
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] or w/ 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.
MIMS Class
Antifungals
ATC Classification
J02AC05 - isavuconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Cresemba cap 100 mg
Packing/Price
1 × 14's
Form
Cresemba powd for conc for soln for infusion 200 mg
Packing/Price
10 mL x 1's
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