Vfend^® (voriconazole)

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VFEND Indication and Important Safety Information

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Indication

VFEND is indicated for use in the treatment of the following fungal infections: invasive aspergillosis; candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds; esophageal candidiasis; and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp, including F. solani, in patients intolerant of, or refractory to, other therapy.

Important Safety Information

Most frequently reported adverse events (all causalities) in therapeutic trials were visual disturbances, fever, rash, vomiting, nausea, diarrhea, headache, sepsis, peripheral edema, abdominal pain, and respiratory disorder. Treatment-related adverse events that most often led to discontinuation in clinical trials were elevated LFTs, rash, and visual disturbances.

VFEND treatment–related visual disturbances are common. The effect of VFEND on visual function is not known if treatment continues beyond 28 days. There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema. If treatment continues beyond 28 days, visual function should be monitored. Patients should be advised not to drive at night when taking VFEND and to avoid potentially hazardous tasks if they perceive any change in vision.

VFEND is contraindicated with terfenadine, astemizole, cisapride, pimozide, quinidine (since increased plasma concentrations of these drugs can lead to QT prolongation and rare occurrences of torsade de pointes), sirolimus, rifampin, rifabutin, carbamazepine, long-acting barbiturates, ergot alkaloids, and St. John’s Wort (Hypericum perforatum). VFEND is also contraindicated with ritonavir (400 mg every 12 hours). If VFEND is coadministered with efavirenz, the VFEND maintenance dose should be increased to 400 mg every 12 hours and the efavirenz dose should be decreased to 300 mg every 24 hours. When treatment with VFEND is stopped, the initial dosage of efavirenz should be restored.

There have been uncommon cases of serious hepatic reactions during treatment with VFEND (clinical hepatitis, cholestasis, and fulminant hepatic failure, including fatalities). LFTs should be evaluated at the start of and during the course of therapy.

Patients have rarely developed serious exfoliative cutaneous reactions, such as Stevens-Johnson syndrome, during treatment with VFEND. If a patient develops an exfoliative cutaneous reaction, VFEND should be discontinued.

VFEND has been associated with photosensitivity skin reaction. Patients should avoid strong, direct sunlight during VFEND therapy. In patients with photosensitivity skin reactions, melanoma and squamous cell carcinoma of the skin have been reported during long-term therapy. If a patient develops a skin lesion consistent with squamous cell carcinoma or melanoma, VFEND should be discontinued.

Pregnancy Category D.

Indication

VFEND is indicated for use in the treatment of the following fungal infections:

Invasive aspergillosis. In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There were a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus.

Candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds.

Esophageal candidiasis.

Serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp., including Fusarium solani, in patients intolerant of, or refractory to, other therapy.

Please see full prescribing information.

VFEND^® I.V. (voriconazole) for Injection/VFEND^® Tablets (voriconazole)/VFEND^® (voriconazole) for Oral Suspension