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.
These events occurred primarily in severely ill patients who had underlying conditions
and/or concomitant medications, which may have caused or contributed to the events.
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 cutaneous reactions, such as Stevens-Johnson
syndrome, during treatment with VFEND.
Pregnancy Category D.