Zuellig Pharma
Concise Prescribing Info
Invasive aspergillosis; fluconazole-resistant serious invasive Candida infections (eg, C krusei); serious Candida infections eg, esophageal candidiasis; candidemia in non-neutropenic patients & the following Candida infections: Disseminated infection in skin, abdomen, kidney, bladder wall & wounds; serious fungal infections caused by Scedosporium spp & Fusarium spp. Prevention of breakthrough fungal infections in febrile high-risk neutropenic patients; prophylaxis in patients ≥12 yr at high risk of developing invasive fungal infections.
Dosage/Direction for Use
Oral All indications Patient ≥40 kg 200 mg (5 mL) every 12 hr, <40 kg 100 mg (2.5 mL) every 12 hr. IV Adult All indications Loading dose: 6 mg/kg every 12 hr for 1st 24 hr. Maintenance: Prevention of breakthrough infections 3 mg/kg every 12 hr after 1st 24 hr. Fluconazole-resistant serious invasive Candida/aspergillosis/Scedosporium & Fusarium infections/prophylaxis of invasive fungal infection 4 mg/kg every 12 hr after 1st 24 hr. Candidemia in non-neutropenic patient & other deep tissue Candida infection 3-4 mg/kg every 12 hr after 1st 24 hr. Childn 2 to <12 yr Loading dose: 9 mg/kg every 12 hr for 1st 24 hr. Maintenance: 8 mg/kg IV bd or 9 mg/kg PO bd after 1st 24 hr, max: 350 mg PO bd. Adolescent 12-14 yr & ≥50 kg; 15-16 yr regardless of body wt Adult dose. Prophylaxis in adult & childn Initiated on day of transplant for up to 100 days. Continuing immunosuppression or graft versus host disease May continue up to 180 days after transplant.
Should be taken on an empty stomach: Take at least 1 hr before or after meals.
Hypersensitivity to voriconazole. Co-administration of CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide, quinidine, ivabradine, sirolimus, rifabutin, rifampicin, carbamazepine, long-acting barbiturates, St. John's wort, efavirenz, high-dose ritonavir (≥400 mg bd), ergot alkaloids, naloxegol, tolvaptan, venetoclax, lurasidone.
Special Precautions
Hypersensitivity to azoles. Infusion related reactions. Discontinue use if severe cutaneous AR develops. Correct electrolyte disturbances prior to therapy. Patients w/ potentially proarrhythmic conditions eg, congenital or acquired QT prolongation, cardiomyopathy, sinus bradycardia, existing symptomatic arrhythmias. Visual adverse events eg, optic neuritis, papilledema; Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction w/ eosinophilia & systemic symptoms; adrenal insufficiency, Cushing's syndrome; squamous cell skin carcinoma, melanoma, non-infectious periostitis. Monitor hepatic, renal & pancreatic function. Avoid exposure to direct sunlight. Long-term use. Not recommended in concomitant use w/ everolimus. Avoid concomitant use w/ phenytoin, ritonavir. Concomitant use w/ medicinal products prolonging QT interval; fluconazole, efavirenz, methadone, short- & long-acting opiates. Hepatic cirrhosis & toxicity; severe hepatic impairment. Renal adverse events. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception. Pregnancy. Not to be used during lactation. Not recommended in childn <2 yr. Powd for infusion: Not recommended for bolus inj. Not to be infused concomitantly w/ any blood product or any short-term infusion of concentrated electrolytes. Moderate to severe renal dysfunction (CrCl <50 mL/min).
Adverse Reactions
Peripheral oedema; headache; visual impairment; diarrhoea, vomiting, abdominal pain, nausea; rash; abnormal liver function test; pyrexia. Sinusitis; agranulocytosis, pancytopenia, thrombocytopenia, leukopenia, anemia; hypoglycaemia, hypokalaemia, hyponatraemia; depression, hallucination, anxiety, insomnia, agitation, confusional state; syncope, tremor, hypertonia, paraesthesia, somnolence, dizziness; retinal haemorrhage; supraventricular arrhythmia, tachycardia, bradycardia; hypotension, phlebitis; acute resp distress syndrome, pulmonary oedema; cheilitis, dyspepsia, constipation, gingivitis; jaundice, cholestatic jaundice, hepatitis; exfoliative dermatitis, alopecia, maculopapular rash, pruritus; back pain; acute renal failure, haematuria; chest pain, face oedema, asthenia, chills; increased blood creatinine.
Drug Interactions
QTc prolongation due to increased plasma conc of astemizole, cisapride, pimozide, quinidine, terfenadine, ivabradine. Decreased plasma conc by carbamazepine, long-acting barbiturates. Decreased Cmax & AUC w/ efavirenz, rifampicin, ritonavir, letermovir. Increased plasma conc of ergot alkaloids, lurasidone, naloxegol, tolvaptan, venetoclax, coumarins, ivacaftor, midazolam, other benzodiazepines, everolimus, ciclosporin, tacrolimus, long-acting opiates, methadone, NSAIDs, omeprazole, other proton-pump inhibitors, OCs, alfentanil, fentanyl, statins, sulphonylureas, vinca alkaloids, prednisolone. Decreased AUC w/ St. John's wort. Increased Cmax & AUC w/ fluconazole, cimetidine. Increased/decreased Cmax & AUC w/ rifabutin, phenytoin. Inhibited metabolism of HIV PIs, NNRTIs.
MIMS Class
ATC Classification
J02AC03 - voriconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Vfend FC tab 200 mg
Vfend FC tab 50 mg
Vfend oral susp 40 mg/mL
70 mL x 1's
Vfend powd for infusion 200 mg
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