Cresemba Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Isavuconazole

Indications/Uses

Invasive aspergillosis; mucormycosis in patients for whom amphotericin B is inappropriate.

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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.

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Overdosage

View Cresemba overdosage for action to be taken in the event of an overdose.

Administration

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

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.

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Special Precautions

Hypersensitivity to other azole antifungals. Discontinue use if severe cutaneous adverse reactions eg, SJS 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.

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Use In Pregnancy & Lactation

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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.

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Drug Interactions

Increased plasma conc w/ CYP3A4/5 inhibitors eg, ketoconazole, lopinavir/ritonavir, clarithromycin, indinavir, saquinavir, fosamprenavir; 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, MTX, daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, topotecan), OCT2 (eg, metformin) & UGT (eg, mycophenolate mofetil) substrates; dextromethorphan. Decreased plasma conc of CYP2B6 (eg, cyclophosphamide, delavirdine, nevirapine, bupropion) & CYP2C8 (eg, repaglinide) substrates; omeprazole.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Cresemba detailed prescribing information

Storage

View Cresemba storage conditions for details to ensure optimal shelf-life.

Description

View Cresemba description for details of the chemical structure and excipients (inactive components).

Action

View Cresemba mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Antifungals

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Cresemba hard cap 100 mg

Packing/Price

14's

Form

Cresemba infusion conc (vial) 200 mg

Packing/Price

1's

Cresemba

isavuconazole

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma