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

Print this page | Cancel

New user?

Why Register?

----------------------------------------------

Returning user?

----------------------------------------------

Forgot Password?

Registration FAQs

Patient Education Materials

Patient Assistance Programs

Clinical Trials

Pipeline

Pfizer Contacts

Pfizer Medical Information
(Search Medical Responses)

WyethHCP.com
(Access Wyeth for Professionals)

Explore Other Online Resources

ppn-vr-sso-links.htm

To report an adverse event or to speak to a member of Pfizer Medical Information, please call 1-800-438-1985

Prescribing Information

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


	Return to the VFEND Product Center

Comp
(not actual size)

Powder for Solution for Injection
VFEND I.V. for Injection is supplied in a single use vial as a sterile lyophilized powder equivalent to 200 mg VFEND and 3200 mg sulfobutyl ether beta-cyclodextrin sodium (SBECD).

Individually packaged vials of 200 mg VFEND I.V.

(NDC 0049-3190-28)

Tablets
VFEND 50 mg tablets; white, film-coated, round, debossed with "Pfizer" on one side and "VOR50" on the reverse.

Bottles of 30 (NDC 0049-3170-30)

VFEND 200 mg tablets; white, film-coated, capsule shaped, debossed with "Pfizer" on one side and "VOR200" on the reverse.

Bottles of 30 (NDC 0049-3180-30)

Powder for Oral Suspension
VFEND for Oral Suspension is supplied in 100 mL high density polyethylene (HDPE) bottles. Each bottle contains 45 g of powder for oral suspension. Following reconstitution, the volume of the suspension is 75 mL, providing a usable volume of 70 mL (40 mg voriconazole/mL). A 5 mL oral dispenser and a press-in bottle adaptor are also provided.

(NDC 0049-3160-44)

STORAGE

VFEND I.V. for Injection unreconstituted vials should be stored at 15° - 30° C
(59° - 86° F) [see USP Controlled Room Temperature]. VFEND is a single dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with Water for Injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8° C (36° to 46° F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8° C (36° to 46° F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used (see DOSAGE AND ADMINISTRATION – Intravenous Administration).

VFEND Tablets should be stored at 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

VFEND Powder for Oral Suspension should be stored at 2° - 8°C (36°- 46° F) (in a refrigerator) before reconstitution. The shelf-life of the powder for oral suspension is 18 months. The reconstituted suspension should be stored at 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Keep the container tightly closed. The shelf-life of the reconstituted suspension is 14 days. Any remaining suspension should be discarded 14 days after reconstitution.

Rx only

Pfizer Roerig

LAB-0271-17.0

Revised November 2006

National Committee for Clinical Laboratory Standards. Reference method for broth dilution antifungal susceptibility testing of conidium-forming filamentous fungi. Approved Standard M38-P. National Committee for Clinical Laboratory Standards, Villanova, Pa.
National Committee for Clinical Laboratory Standards. Reference method for broth dilution antifungal susceptibility testing of yeasts. Approved Standard M27-A. National Committee for Clinical Laboratory Standards, Villanova, Pa.

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