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

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Prescribing Information

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


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VISUAL DISTURBANCES: 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. These events occurred primarily in severely ill patients who had underlying conditions and/or concomitant medications which may have caused or contributed to these events. If treatment continues beyond 28 days, visual function including visual acuity, visual field and color perception should be monitored (see PRECAUTIONS – Information for Patients and ADVERSE REACTIONS – Visual Disturbances).

HEPATIC TOXICITY: In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with VFEND (including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities). Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly hematological malignancy). Hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. Liver dysfunction has usually been reversible on discontinuation of therapy (see PRECAUTIONS – Laboratory Tests and ADVERSE REACTIONS – Clinical Laboratory Values).

Monitoring of hepatic function: Liver function tests should be evaluated at the start of and during the course of VFEND therapy. Patients who develop abnormal liver function tests during VFEND therapy should be monitored for the development of more severe hepatic injury. Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin). Discontinuation of VFEND must be considered if clinical signs and symptoms consistent with liver disease develop that may be attributable to VFEND (see PRECAUTIONS – Laboratory Tests, DOSAGE AND ADMINISTRATION – Dosage Adjustment, ADVERSE REACTIONS - Clinical Laboratory Tests).

Pregnancy Category D: Voriconazole can cause fetal harm when administered to a pregnant woman.

Voriconazole was teratogenic in rats (cleft palates, hydronephrosis/hydroureter) from 10 mg/kg (0.3 times the recommended maintenance dose (RMD) on a mg/m² basis) and embryotoxic in rabbits at 100 mg/kg (6 times the RMD). Other effects in rats included reduced ossification of sacral and caudal vertebrae, skull, pubic and hyoid bone, supernumerary ribs, anomalies of the sternebrae and dilatation of the ureter/renal pelvis. Plasma estradiol in pregnant rats was reduced at all dose levels. Voriconazole treatment in rats produced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose. The effects seen in rabbits were an increased embryomortality, reduced fetal weight and increased incidences of skeletal variations, cervical ribs and extrasternebral ossification sites.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Galactose intolerance: VFEND tablets contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

PRINTER-FRIENDLY

VFEND Indication and Important Safety Information

Please scroll to see the Indication below.

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

vfend_safety_information.htm