Voraiz Special Precautions

Hypersensitivity: Voriconazole should be used with caution in patients hypersensitive to other azoles.
Hepatic effects: Serious hepatic effects, including hepatitis, cholestasis, and fulminant hepatic failure, have been reported rarely in clinical trials. Hepatic effects (including hepatitis and jaundice) have occurred in patients with no identifiable risk factors. Hepatic effects usually are reversible when Voriconazole is discontinued; however, fatalities have occurred. If abnormal liver function test results occur during Voriconazole therapy, the patient should be monitored for the development of more severe hepatic injury using appropriate laboratory evaluations (particularly liver function tests and bilirubin). Discontinuance of Voriconazole must be considered if signs and symptoms consistent with liver disease develop.
Ocular effects: Visual disturbances (e.g. abnormal vision, blurred vision, color vision change, photophobia) have been reported and may be related to high dosage and high plasma Voriconazole concentrations. There have been postmarketing reports of prolonged visual disturbances, including optic neuritis and papilledema, in patients receiving Voriconazole. Effect of Voriconazole on visual function is unknown if duration of therapy exceeds 28 days. Monitor visual function (visual acuity, visual field, and color perception) if duration of therapy exceeds 28 days.
Cardiovascular effects: Voriconazole has been associated with prolongation of QT interval. Arrhythmias (e.g. torsades de pointes), cardiac arrest, and sudden death have occurred rarely on patients receiving Voriconazole. Voriconazole should be used with caution in patients with potentially proarrhythmic conditions. Rigorous attempts should be made to correct electrolyte imbalances (i.e. potassium, magnesium, calcium) before initiating Voriconazole therapy.
Dermatologic effects: Serious exfoliative cutaneous reactions (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis) have occurred rarely in patients receiving Voriconazole. If an exfoliative cutaneous reaction occurs, Voriconazole should be discontinued. Photosensitivity skin reactions have been reported in patients receiving Voriconazole. Patients receiving the drug should avoid intense or prolonged exposure to direct sunlight. Squamous cell carcinoma of the skin and melanoma have been reported during long-term Voriconazole therapy in patients with photosensitivity reactions. If a skin lesion consistent with squamous cell carcinoma or melanoma develops, Voriconazole should be discontinued.
Renal effects: Acute renal failure has been reported in severely ill patients with other factors predisposing to impaired renal function (e.g. underlying conditions, concomitant nephrotoxic drugs).
Skeletal effects: Fluorosis and periostitis have been reported during long-term Voriconazole therapy. If a patient develops skeletal pain and radiologic findings compatible with fluorosis or periostitis, Voriconazole should be discontinued.
Effects on Ability to Drive and Use Machines: Voriconazole may cause transient and reversible changes to vision, including blurring, altered/enhanced visual perception and/or photophobia. Patients must avoid potentially hazardous tasks, such as driving or operating machinery while experiencing these symptoms. Patients should not drive at night while taking voriconazole.