Sorry, you need to enable JavaScript to visit this website.

This site is intended only for healthcare professionals resident in the United Kingdom

Prescribing information can be found at the bottom of the page

Adverse events with voriconazole were generally mild-to-moderate in a database of more than 2,000 treated subjects1

Visual disturbances1

Very common (≥1/10) in clinical trials:

  • Including altered/ enhanced visual perception, blurred vision, colour vision change or photophobia
  • Transient and fully reversible, with the majority spontaneously resolving within 60 minutes although there have been reports of prolonged visual adverse events
  • Generally mild, rarely resulted in discontinuation and have not been associated with long-term sequelae
  • May be associated with higher plasma concentrations and/or doses

Skin reactions1

Very common (≥1/10) in clinical trials:

  • Majority of rashes were of mild-to-moderate severity
  • Patients have rarely developed serious cutaneous reactions, and uncommonly developed Stevens-Johnson syndrome
  • If a patient develops a rash he should be monitored closely and voriconazole discontinued if lesions progress
  • Associated with photo-toxicity and pseudoporphyria
  • Patients, including children, should avoid intense or prolonged exposure to direct sunlight during treatment and use measures such as protective clothing and sunscreen with high sun protection factor
  • Squamous cell carcinoma (SCC) has been reported in patients, some of whom have reported prior photo-toxic reactions
  • Seek dermatological evaluation on a regular basis. Discontinue voriconazole therapy if premalignant skin lesions or SCC are identified

Liver function tests1

  • 18% of adults and 25.8% of paediatric patients taking voriconazole developed clinically significant transaminase abnormalities during the clinical trial programme
  • Majority of abnormal liver function tests either resolved during treatment without dose adjustment or following dose adjustment, including discontinuation of therapy
  • Cases of serious hepatic toxicity occurred primarily in patients with other serious underlying conditions
  • Monitoring of hepatic function should be carried out in both children and adults. Clinical management should include laboratory evaluation of hepatic function (specifically aspartate transaminase (AST) and alanine transaminase (ALT)) at the initiation of treatment with voriconazole and at least weekly for the first month of treatment:
     
    • Treatment should be as short as possible; if the treatment is continued based on the benefit-risk assessment, monitoring frequency can be reduced to monthly if there are no changes in the liver function tests
    • If the liver function tests become markedly elevated, voriconazole should be discontinued, unless the medical judgment of the risk-benefit of the treatment for the patient justifies continued use
    • There are limited data on the safety of voriconazole in patients with abnormal liver function tests (AST, ALT, alkaline phosphatase (ALP))or total bilirubin >5 times the upper limit of normal

See Vfend Summary of Product Characteristics for more information1

References

  1. Vfend® Summary of Product Characteristics.