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: 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:
	pimozide rifampin efavirenz ergotamine, dihydroergotamine (ergot alkaloids) tolvaptan venetoclax	quinidine carbamazepine ritonavir St.John’s Wort (herbal supplement) lurasidone	sirolimus long-acting barbiturates like phenobarbital rifabutin naloxegol ivabradine
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 low potassium levels, low magnesium levels, and low calcium levels. Your healthcare provider may do blood tests before starting and during treatment with 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 breastfeeding or plan to breastfeed. 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 3 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 adrenal gland problems VFEND may cause reduced adrenal function (adrenal insufficiency). VFEND may cause overactive adrenal function (Cushing’s syndrome) when voriconazole is used at the same time with corticosteroids. Symptoms of adrenal insufficiency include:
	feeling tired nausea and vomiting abdominal pain	lack of energy feeling dizzy or lightheaded	weakness weight loss
	Symptoms of Cushing’s syndrome include:
	weight gain thinning skin excessive hair growth	fatty hump between the shoulders (buffalo hump) and a rounded face (moon face) bruising easily excessive sweating	darkening of the skin on the stomach, thighs, breasts, and arms high blood sugar
bone problems. VFEND may cause weakening of bones and bone pain. Tell your healthcare provider if you have bone pain. 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 swelling in the arms and legs high blood sugar levels headache fast heart beat (tachycardia) nose bleeds low blood potassium levels	inflammation of mucous membranes hallucinations (seeing or hearing things that are not there) coughing up blood constipation low blood magnesium levels fullness of the stomach area vomiting nausea upper respiratory tract infection
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. 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