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.
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)].
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patients should be instructed that visual disturbances such as blurring and sensitivity to light may occur with the use of VFEND.
- Advise patients of the risk of photosensitivity (with or without concomitant methotrexate), accelerated photoaging, and skin cancer.
- Advise patients that VFEND can cause serious photosensitivity and to immediately contact their healthcare provider for new or worsening skin rash.
- Advise patients to avoid exposure to direct sun light and to use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
- Advise female patients of the potential risks to a fetus.
- Advise females of reproductive potential to use effective contraception during treatment with VFEND.
Division of Pfizer IncNew York, NY 10017
Novaplus is a registered trademark of Vizient, Inc.
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.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: August 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:
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:
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins and herbal supplements.VFEND may affect the way other medicines work, and other medicines may affect how VFEND works.Know what medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I take VFEND?
What should I avoid while taking VFEND?
What are possible side effects of VFEND? VFEND may cause serious side effects including:
Symptoms of adrenal insufficiency include:
Symptoms of Cushing’s syndrome include:
Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.The most common side effects of VFEND in adults include:
The most common side effects of VFEND in children include:
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?
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.
Distributed byRoerigDivision of Pfizer IncNew York, NY 10017
Novaplus is a registered trademark of Vizient, Inc.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.
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