Vortimal Side Effects

(See Table 4.)

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Description of selected adverse reactions: Visual disturbances: Visual impairments with voriconazole were very common. The visual disturbances include altered/enhanced visual perception, blurred vision, colour vision change or photophobia. These visual disturbances were transient and fully reversible, with the majority spontaneously resolving within 60 minutes and no clinically significant long-term visual effects were observed. There was evidence of attenuation with repeated doses of voriconazole. The visual disturbances were generally mild, rarely resulted in discontinuation and were not associated with long-term sequelae. Visual disturbances may be associated with higher plasma concentrations and/or doses. The mechanism of action is unknown, although the site of action is most likely to be within the retina.
There have been post-marketing reports of prolonged visual adverse events (see Precautions).
Dermatological reactions: Dermatological reactions were common in patients treated with voriconazole and were receiving multiple concomitant medicinal products. The majority of rashes were of mild to moderate severity. Patients have rarely developed serious cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme during treatment with voriconazole.
If a patient develops a rash they should be monitored closely and voriconazole discontinued if lesions progress. Photosensitivity reactions have been reported, especially during long-term therapy (see Precautions).
There have been reports of squamous cell carcinoma of the skin in patients treated with voriconazole for long periods of time; the mechanism has not been established (see Precautions).
Liver function tests: Liver function test abnormalities may be associated with higher plasma concentrations and/or doses. The majority of abnormal liver function tests either resolved during treatment without dose adjustment or following dose adjustment, including discontinuation of therapy. Voriconazole has been infrequently associated with cases of serious hepatic toxicity in patients with other serious underlying conditions. This includes cases of jaundice, and rare cases of hepatitis and hepatic failure leading to death (see Precautions).
Infusion-related reactions: During infusion of the intravenous formulation of voriconazole, anaphylactoid-type reactions, including flushing, fever, sweating, tachycardia, chest tightness, dyspnoea, faintness, nausea, pruritus and rash have occurred. Symptoms appeared immediately upon initiating the infusion (see Precautions).
Prophylaxis: Discontinuation of voriconazole treatment has been reported in other study comparing voriconazole and itraconazole as primary prophylaxis in adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI, following adverse effects and treatment-emergent hepatic side effects.
Paediatric population: The adverse reaction profile of the paediatric patients was similar to that in adults. Post-marketing data suggest there might be a higher occurrence of skin reactions (especially erythema) in the paediatric population compared to adults.