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

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Prescribing Information

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


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VFEND is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. There is no information regarding cross-sensitivity between VFEND (voriconazole) and other azole antifungal agents. Caution should be used when prescribing VFEND to patients with hypersensitivity to other azoles.

Coadministration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine with VFEND are contraindicated since increased plasma concentrations of these drugs can lead to QT prolongation and rare occurrences of torsade de pointes (see CLINICAL PHARMACOLOGY – Drug Interactions, PRECAUTIONS – Drug Interactions).

Coadministration of VFEND with sirolimus is contraindicated because VFEND significantly increases sirolimus concentrations in healthy subjects (see CLINICAL PHARMACOLOGY – Drug Interactions, PRECAUTIONS – Drug Interactions).

Coadministration of VFEND with rifampin, carbamazepine and long–acting barbiturates is contraindicated since these drugs are likely to decrease plasma voriconazole concentrations significantly (see CLINICAL PHARMACOLOGY – Drug Interactions, PRECAUTIONS – Drug Interactions).

Coadministration of VFEND with high–dose ritonavir (400 mg Q12h) is contraindicated because ritonavir (400 mg Q12h) significantly decreases plasma voriconazole concentrations in healthy subjects. Coadministration of voriconazole and low-dose ritonavir (100 mg Q12h) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see CLINICAL PHARMACOLOGY – Drug Interactions, PRECAUTIONS – Drug Interactions).

Coadministration of standard doses of VFEND with efavirenz is contraindicated because efavirenz significantly decreases voriconazole plasma concentrations while VFEND also significantly increases efavirenz plasma concentrations. Concomitant use of adjusted doses of voriconazole and efavirenz may be administered (see CLINICAL PHARMACOLOGY – Drug Interactions, PRECAUTIONS – Drug Interactions).

Coadministration of VFEND with rifabutin is contraindicated since VFEND significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations (see CLINICAL PHARMACOLOGY – Drug Interactions, PRECAUTIONS – Drug Interactions).

Coadministration of VFEND with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because VFEND may increase the plasma concentration of ergot alkaloids, which may lead to ergotism.

PRINTER-FRIENDLY

VFEND Safety Information

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.

Please see full prescribing information.

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

vfend_safety_information.htm