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VFEND® (voriconazole) tablets, for oral suspension, for intravenous use Information for Patients

This Patient Information has been approved by the U.S. Food and Drug Administration.
PATIENT INFORMATION
VFEND®
(VEE-fend)
(voriconazole)
tablets, for oral use
VFEND®
(VEE-fend)
(voriconazole)
for oral suspension
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:
  • are allergic to voriconazole or any of the ingredients in VFEND. See the end of this leaflet for a complete list of ingredients in VFEND.
  • are taking any of the following medicines:
  • cisapride
  • sirolimus
  • long-acting barbiturates like phenobarbital
  • rifabutin
  • pimozide
  • rifampin
  • efavirenz
  • ergotamine, dihydroergotamine (ergot alkaloids)
  • quinidine
  • carbamazepine
  • ritonavir
  • St. John's Wort (herbal supplement)
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:
  • have or ever had heart disease, or an abnormal heart rate or rhythm. Your healthcare provider may order a test to check your heart (EKG) before starting VFEND.
  • have liver or kidney problems. Your healthcare provider may do blood tests to make sure you can take VFEND.
  • have trouble digesting dairy products, lactose (milk sugar), or regular table sugar. VFEND tablets contain lactose. VFEND liquid contains sucrose (table sugar).
  • are pregnant or plan to become pregnant. VFEND can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. Women who can become pregnant should use effective birth control while taking VFEND. Talk to your healthcare provider about birth control methods that may be right for you.
  • are breast-feeding or plan to breast-feed. It is not known if VFEND passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VFEND.
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?
  • VFEND may be prescribed to you as:
    • VFEND I.V. (intravenous infusion) or
    • VFEND tablets or
    • VFEND oral suspension
  • VFEND I.V. will be given to you by a healthcare provider over 1 to 2 hours.
  • Take VFEND tablets or oral suspension exactly as your healthcare provider tells you to.
  • Take VFEND tablets or oral suspension at least 1 hour before or at least 1 hour after meals.
  • VFEND oral suspension will be mixed for you by your pharmacist. Shake the bottle of VFEND oral suspension for 10 seconds each time before you use it.
  • Only use the oral dispenser that comes with your VFEND oral suspension to administer your medicine.
  • Do not mix VFEND oral suspension with any other medicine, flavored liquid, or syrup.
  • If you take too much VFEND, call your healthcare provider or go to the nearest hospital emergency room.
What should I avoid while taking VFEND?
  • You should not drive at night while taking VFEND. VFEND can cause changes in your vision such as blurring or sensitivity to light.
  • Do not drive or operate machinery, or do other dangerous activities until you know how VFEND affects you.
  • Avoid direct sunlight. VFEND can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your healthcare provider if you get sunburn.
What are possible side effects of VFEND?
VFEND may cause serious side effects including:
  • liver problems. Symptoms of liver problems may include:
  • itchy skin
  • flu-like symptoms
  • yellowing of your eyes
  • nausea or vomiting
  • feeling very tired
  • vision changes. Symptoms of vision changes may include:
    • blurred vision
    • changes in the way you see colors
    • sensitivity to light (photophobia)
  • serious heart problems. VFEND may cause changes in your heart rate or rhythm, including your heart stopping (cardiac arrest).
  • allergic reactions. Symptoms of an allergic reaction may include:
  • fever
  • chest tightness
  • nausea
  • sweating
  • trouble breathing
  • itching
  • feels like your heart is beating fast (tachycardia)
  • feel faint
  • skin rash
  • kidney problems. VFEND may cause new or worse problems with kidney function, including kidney failure. Your healthcare provider should check your kidney function while you are taking VFEND. Your healthcare provider will decide if you can keep taking VFEND.
  • serious skin reactions. Symptoms of serious skin reactions may include:
    • rash or hives
    • mouth sores
    • blistering or peeling of your skin
    • trouble swallowing or breathing
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:
  • vision changes
  • nausea
  • hallucinations (seeing or hearing things that are not there)
  • rash
  • headache
  • abnormal liver function tests
  • chills
  • vomiting
  • fast heart beat (tachycardia)
  • fever
The most common side effects of VFEND in children include:
  • fever
  • diarrhea
  • low platelet counts
  • abnormal liver function tests
  • low blood calcium levels
  • low blood phosphate levels
  • vision changes
  • rash
  • stomach pain
  • high blood pressure
  • cough
  • low blood pressure
  • high blood sugar levels
  • headache
  • fast heart beat (tachycardia)
  • nose bleeds
  • low blood potassium levels
  • Inflammation of mucous membranes
  • constipation
  • low blood magnesium levels
  • Fullness of the stomach area
  • vomiting
  • nausea
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?
  • Store VFEND tablets and liquid at room temperature, 59°F to 86°F (15°C to 30°C). Do not refrigerate or freeze.
  • VFEND suspension should be thrown away (discarded) after 14 days.
  • Keep VFEND tablets and oral suspension in a tightly closed container.
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep VFEND, as well as all other medicines, out of the reach of children.
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
For more information, go to www.pfizer.com or call 1-800-438-1985
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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LAB-0311-14.0

Revised: January 2019

INSTRUCTIONS FOR USE
VFEND® (VEE-fend)
(voriconazole)
for oral suspension

Read this Instructions for Use before you start taking VFEND 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 medical condition or treatment.

Important information:

  • Follow your healthcare provider's instructions for the dose of VFEND to take.
  • Ask your healthcare provider or pharmacist if you are not sure how to take VFEND.
  • VFEND for oral suspension is a liquid form of VFEND. Your pharmacist will mix (reconstitute) the medicine before it is dispensed to you. If VFEND is still in powder form, do not use it. Return it to your pharmacist.
  • Always use the oral dispenser provided with VFEND to make sure you measure the right amount of VFEND.
  • Shake the closed bottle of mixed (reconstituted) oral suspension well for about 10 seconds before each use.

Each pack contains:

Figure

How to prepare the bottle and take VFEND:

1.

Figure

Remove the child-resistant bottle cap by pushing down while twisting the cap to the left (counter-clockwise).

2.

Figure

Push the bottle adapter firmly into the bottle (if your pharmacist has not already inserted the bottle adapter). If the bottle adapter is missing, contact your pharmacist.
Do not remove the bottle adapter after it is inserted.

3.

Figure

Important: Bottle adapter must be fully inserted before use.

4.

Figure

Pull back on the oral dispenser plunger to your prescribed dose.

5.

Figure

Insert the tip of the oral dispenser into the bottle adapter.

6.

Figure

While holding the bottle with 1 hand, push down on the oral dispenser plunger with your other hand to push air into the bottle.

7.

Figure

Turn the bottle upside down and slowly pull back on the oral dispenser plunger to withdraw your prescribed dose of medicine.

8.

Figure

Turn the bottle back upright with the oral dispenser still in place. Remove the tip of the oral dispenser from the bottle adapter.
Place the tip of the oral dispenser in your mouth and point the tip of the oral dispenser towards the inside of the cheek. Slowly push the plunger until all the medicine is given. Do not squirt the medicine out quickly. This may cause you to choke.
If the medicine is to be given to a child, keep your child in an upright position while giving the medicine.

9.

Figure

Screw the bottle cap back on the bottle tightly by turning the cap to the right (clockwise).
Do not remove the bottle adapter. The bottle cap will fit over it.

Rinse the oral dispenser after each use.

  • Pull the plunger out of the oral dispenser and wash both parts with warm soapy water.
  • Rinse both parts with water and allow to air dry after each use.
  • After air drying, push the plunger back into the oral dispenser.
  • Store the oral dispenser with VFEND oral suspension in a clean safe place.

How should I store VFEND oral suspension?

  • Store VFEND oral suspension at room temperature between 59°F to 86°F (15°C to 30°C).
  • Do not refrigerate or freeze.
  • Keep the bottle cap tightly closed.
  • Use VFEND oral suspension within 14 days after it has been mixed (reconstituted) by the pharmacist. The pharmacist will write the expiration date on the bottle label (the expiration date of the oral suspension is 14 days from the date it was mixed (reconstituted) by the pharmacist). Throw away (discard) any unused VFEND after the expiration date.
  • Keep VFEND and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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LAB-1348-1.0
Revised: 04/2019

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