VFEND (Page 12 of 13)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Powder for Solution for Injection
VFEND I.V. for Injection is supplied in a single-dose vial as a sterile lyophilized powder equivalent to 200 mg voriconazole and 3,200 mg sulfobutyl ether beta-cyclodextrin sodium (SBECD). It does not contain preservatives and is not made with natural rubber latex.
Individually packaged vials of 200 mg VFEND I.V.
(NDC 0049-3190-38)
16.2 Storage
VFEND I.V. for Injection unreconstituted vials should be stored at 15°C to 30°C (59°F to 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°C to 8°C (36°F to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C (36°F 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 (2.1)].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Embryo-Fetal Toxicity
- Advise female patients of the potential risks to a fetus.
- Advise females of reproductive potential to use effective contraception during treatment with VFEND.
Distributed by
Roerig
Division of Pfizer IncNew York, NY 10017

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For Medical Information about VFEND please visit www.pfizermedinfo.com or call 1-800-438-1985.
LAB-0632-14.0
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 1/2022 | ||
PATIENT INFORMATION VFEND® (VEE-fend) (voriconazole)for injection, for intravenous use | |||
Read the Patient Information that comes with VFEND before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your condition or treatment. | |||
What is VFEND? VFEND is a prescription medicine used to treat certain serious fungal infections in your blood and body. These infections are called “aspergillosis,” “esophageal candidiasis,” “Scedosporium, ” “Fusarium, ” and “candidemia”. It is not known if VFEND is safe and effective in children younger than 2 years old. | |||
Do not take VFEND if you:
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Ask your healthcare provider or pharmacist if you are not sure if you are taking any of the medicines listed above. Do not start taking a new medicine without talking to your healthcare provider or pharmacist. | |||
Before you take VFEND, tell your healthcare provider about all of your medical conditions, including if you:
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How should I take VFEND?
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What should I avoid while taking VFEND?
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What are possible side effects of VFEND? VFEND may cause serious side effects including: | |||
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Symptoms of Cushing’s syndrome include: | |||
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The most common side effects of VFEND in children include: | |||
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Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VFEND. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
How should I store VFEND?
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General information about the safe and effective use of VFEND. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VFEND for a condition for which it was not prescribed. Do not give VFEND to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about VFEND that is written for health professionals. | |||
What are the ingredients in VFEND?Active ingredient: voriconazole. Inactive ingredients: VFEND IV: sulfobutyl ether beta-cyclodextrin sodium. VFEND tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. VFEND oral suspension: anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum. Distributed byRoerigDivision of Pfizer IncNew York, NY 10017 ![]() This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. For more information, go to www.pfizer.com or call 1-800-438-1985. |
LAB-0633-11.0
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