(voriconazole)

Prescribing Information
Download Prescribing Information

8 USE IN SPECIFIC POPULATIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Voriconazole can cause fetal harm when administered to a pregnant woman. There are no available data on the use of VFEND in pregnant women. In animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. Cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the RMD of 200 mg every 12 hours based on body surface area comparisons). In rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the RMD based on body surface area comparisons) during organogenesis. Rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see Data]. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see Warnings and Precautions (5.9)].

The background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20% respectively.

Data

Animal Data

Voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6–17) at 10, 30, and 60 mg/kg/day..Voriconazole was associated with increased incidences of the malformations hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (RMD) based on body surface area comparisons, and cleft palate at 60 mg/kg, approximately 2 times the RMD based on body surface area comparisons. Reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. There was no evidence of maternal toxicity at any dose.

Voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7–19) at 10, 40, and 100 mg/kg/day. Voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100 mg/kg/day (6 times the RMD based on body surface area comparisons). Fetal skeletal variations (increases in the incidence of cervical rib and extra sternebral ossification sites) were observed at 100 mg/kg/day.

In a peri- and postnatal toxicity study in rats, voriconazole was administered orally to female rats from implantation through the end of lactation at 1, 3, and 10 mg/kg/day. Voriconazole prolonged the duration of gestation and labor and produced dystocia with related increases in maternal mortality and decreases in perinatal survival of F1 pups at 10 mg/kg/day, approximately 0.3 times the RMD.

8.2 Lactation

Risk Summary

No data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VFEND and any potential adverse effects on the breastfed child from VFEND or from the underlying maternal condition.

8.3 Females and Males of Reproductive Potential

   

Contraception

Advise females of reproductive potential to use effective contraception during treatment with VFEND. The coadministration of voriconazole with the oral contraceptive, Ortho-Novum® (35 mcg ethinyl estradiol and 1 mg norethindrone), results in an interaction between these two drugs, but is unlikely to reduce the contraceptive effect. Monitoring for adverse reactions associated with oral contraceptives and voriconazole is recommended [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

8.4 Pediatric Use

The safety and effectiveness of VFEND have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. A total of 105 pediatric patients aged 2 to less than 12 [N=26] and aged 12 to less than 18 [N=79] from two, non-comparative Phase 3 pediatric studies and eight adult therapeutic trials provided safety information for VFEND use in the pediatric population [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

Safety and effectiveness in pediatric patients below the age of 2 years has not been established. Therefore, VFEND is not recommended for pediatric patients less than 2 years of age.

A higher frequency of liver enzyme elevations was observed in the pediatric patients [see Dosage and Administration (2.5), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

The frequency of phototoxicity reactions is higher in the pediatric population. Squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. Stringent measures for photoprotection are warranted. Sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation [see Warnings and Precautions (5.6)].

VFEND has not been studied in pediatric patients with hepatic or renal impairment [see Dosage and Administration (2.5, 2.6)]. Hepatic function and serum creatinine levels should be closely monitored in pediatric patients [see Dosage and Administration (2.6) and Warnings and Precautions (5.1, 5.10)].

8.5 Geriatric Use

In multiple dose therapeutic trials of voriconazole, 9.2% of patients were ≥65 years of age and 1.8% of patients were ≥75 years of age. In a study in healthy subjects, the systemic exposure (AUC) and peak plasma concentrations (Cmax) were increased in elderly males compared to young males. Pharmacokinetic data obtained from 552 patients from 10 voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either IV or oral administration. However, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see Clinical Pharmacology (12.3)].

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.     Revised: 1/2026

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:
o
carbamazepine
o
efavirenz
o
eplerenone
o
ergotamine, dihydroergotamine (ergot alkaloids)
o
finerenone
o
ivabradine
o
long-acting barbiturates like phenobarbital
o
lurasidone
o
naloxegol
o
pimozide
o
quinidine
o
rifabutin
o
rifampin
o
ritonavir
o
sirolimus
o
St. John’s Wort (herbal supplement)
o
tolvaptan
o
venetoclax
o
voclosporin

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 oral suspension 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:
o
VFEND I.V. (intravenous infusion) or
o
VFEND tablets or
o
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 the possible side effects of VFEND?

VFEND may cause serious side effects including:

•
liver problems. Symptoms of liver problems may include:
o
itchy skin
o
flu-like symptoms
o
yellowing of your eyes
o
nausea or vomiting
o
feeling very tired
•
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:
o
fever
o
chest tightness
o
nausea
o
flushing
o
sweating
o
trouble breathing
o
itching
o
feels like your heart is beating fast (tachycardia)
o
feel faint
o
skin rash
•
vision changes. Symptoms of vision changes may include:
o
blurred vision
o
changes in the way you see colors
•
serious skin reactions. Symptoms of serious skin reactions may include:
o
rash or hives
o
mouth sores
o
blistering or peeling of your skin
o
trouble swallowing or breathing
•
sensitivity to light or sun (photosensitivity). VFEND can cause serious photosensitivity. There is an increased chance of skin toxicity while taking VFEND. This can happen with or without taking other medicines like methotrexate. Photosensitivity reactions may also increase your risk of:
o
faster skin aging from the sun
o
skin cancer

Call your healthcare provider right away if you get a new skin rash or your skin rash gets worse.

•
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.
•
adrenal gland problems:
o
VFEND may cause reduced adrenal function (adrenal insufficiency).
o
VFEND may cause overactive adrenal function (Cushing’s syndrome) when voriconazole is used at the same time with corticosteroids.
 
Symptoms of adrenal insufficiency include:
o
feeling tired
o
nausea and vomiting
o
abdominal pain
o
lack of energy
o
feeling dizzy or lightheaded
o
weakness
o
weight loss

Symptoms of Cushing's syndrome include:

o
weight gain
o
thinning skin
o
excessive hair growth
o
fatty hump between the shoulders (buffalo hump) and a rounded face (moon face)
o
bruising easily
o
excessive sweating
o
darkening of the skin on the stomach, thighs, breasts, and arms
o
high blood sugar
•
inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis may include pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back. The pain may happen with or without vomiting.
•
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:

o
vision changes
o
nausea
o
hallucinations (seeing or hearing things that are not there)
o
rash
o
headache
o
abnormal liver function tests
o
chills
o
vomiting
o
fast heart beat (tachycardia)
o
fever

The most common side effects of VFEND in children include:

o
fever
o
diarrhea
o
low platelet counts
o
abnormal liver function tests
o
low blood calcium levels
o
low blood phosphate levels
o
vision changes
o
rash
o
stomach pain
o
trouble breathing
o
dizziness
o
high blood pressure
o
cough
o
low blood pressure
o
swelling in the arms and legs
o
high blood sugar levels
o
headache
o
fast heart beat (tachycardia)
o
nose bleeds
o
low blood potassium levels
o
low blood levels of albumin
o
kidney problems
o
inflammation of mucous membranes
o
hallucinations (seeing or hearing things that are not there)
o
coughing up blood
o
constipation
o
low blood magnesium levels
o
fullness of the stomach area
o
vomiting
o
nausea
o
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 oral suspension at room temperature between 59°F to 86°F (15°C to 30°C). Do not refrigerate or freeze.
•
VFEND oral 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.

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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-0311-23.0

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