Prescription Drug Information: VFEND (Page 9 of 10)

14.5 Pediatric Studies

A total of 22 patients aged 12 to 18 years with IA were included in the adult therapeutic studies. Twelve out of 22 (55%) patients had successful response after treatment with a maintenance dose of voriconazole 4 mg/kg every 12 hours.

Fifty-three pediatric patients aged 2 to less than 18 years old were treated with voriconazole in two prospective, open-label, non-comparative, multicenter clinical studies.

One study was designed to enroll pediatric patients with IA or infections with rare molds (such as Scedosporium or Fusarium). Patients aged 2 to less than 12 years and 12 to 14 years with body weight less than 50 kg received an intravenous VFEND loading dose of 9 mg/kg every 12 hours for the first 24-hours followed by an 8 mg/kg intravenous maintenance dose every 12 hours. After completing 7 days of intravenous therapy patients had an option to switch to oral VFEND. The oral maintenance dose was 9 mg/kg every 12 hours (maximum dose of 350 mg). All other pediatric patients aged 12 to less than 18 years received the adult VFEND dosage regimen. Patients received VFEND for at least 6 weeks and up to a maximum of 12 weeks.

The study enrolled 31 patients with possible, proven, or probable IA. Fourteen of 31 patients, 5 of whom were 2 to less than 12 years old and 9 of whom were 12 to less than 18 years old, had proven or probable IA and were included in the modified intent-to-treat (MITT) efficacy analyses. No patients with rare mold were enrolled. A successful global response was defined as resolution or improvement in clinical signs and symptoms and at least 50% resolution of radiological lesions attributed to IA. The overall rate of successful global response at 6 weeks in the MITT population is presented in Table 18 below.

Table 18: Global Response * in Patients with Invasive Aspergillosis, Modified Intent-to-Treat (MITT) Population
Parameter Global Response at Week 6
Ages 2–<12 years N=5 Ages 12–<18 years N=9 Overall N=14
*
Global response rate was defined as the number of subjects with a successful response (complete or partial) as a percentage of all subjects (including subjects with an indeterminate or missing response) at 6 weeks in the MITT population.
The Modified Intent-to-Treat (MITT) population was defined as all subjects who received at least 1 dose of study drug and who were diagnosed with proven or probable IA as defined by the modified EORTC/MSG criteria.

Number of successes, n (%)

2 (40%)

7 (78%)

9 (64%)

The second study enrolled 22 patients with invasive candidiasis including candidemia (ICC) and EC requiring either primary or salvage therapy. Patients with ICC aged 2 to less than 12 years and 12 to 14 years with body weight less than 50 kg received an intravenous VFEND loading dose of 9 mg/kg every 12 hours for the first 24 hours followed by an 8 mg/kg intravenous maintenance dose every 12-hours. After completing 5 days of intravenous therapy patients had an option to switch to oral VFEND. The oral maintenance dose was 9 mg/kg every 12 hours (maximum dose of 350 mg). All other pediatric patients aged 12 to less than 18 years received the adult VFEND dosage regimen. VFEND was administered for at least 14 days after the last positive culture. A maximum of 42 days of treatment was permitted.

Patients with primary or salvage EC aged 2 to less than 12 years and 12 to 14 years with body weight less than 50 kg received an intravenous VFEND dose of 4 mg/kg every 12 hours followed by an oral VFEND dose of 9 mg/kg every 12 hours (maximum dose of 350 mg) when criteria for oral switch were met. All other pediatric patients aged 12 to less than 18 years received the adult VFEND dosage regimen. VFEND was administered for at least 7 days after the resolution of clinical signs and symptoms. A maximum of 42 days of treatment was permitted.

For EC, study treatment was initiated without a loading dose of intravenous voriconazole. Seventeen of these patients had confirmed Candida infection and were included in the MITT efficacy analyses. Of the 17 patients included in the MITT analyses, 9 were 2 to less than 12 years old (7 with ICC and 2 with EC) and 8 were 12 to less than18 years old (all with EC). For ICC and EC, a successful global response was defined as clinical cure or improvement with microbiological eradication or presumed eradication. The overall rate of successful global response at EOT in the MITT population is presented in Table 19 below.

Table 19: Global Response * at the End of Treatment in the Treatment of Invasive Candidiasis with Candidemia and Esophageal Candidiasis Modified Intent-to-Treat (MITT) Population
Parameter Global Response at End of Treatment
EC N=10 ICC N=7
Ages 2–<12 N=2 Ages 12–<18 N=8 Overall N=10 Overall N=7
*
Global response was determined based on the investigator’s assessment of clinical and microbiological response in the Modified Intent-to-Treat (MITT) analysis population at end of treatment. Subjects with missing data or whose response was deemed indeterminate were considered failures.
The MITT population was defined as all subjects who received at least 1 dose of study drug and who had microbiologically confirmed invasive candidiasis with candidemia (ICC) and EC, or subjects with EC who had at least confirmation of oropharyngeal candidiasis without confirmation on esophagoscopy.
All subjects with ICC were aged 2 to less than 12.

Number of successes, n (%)

2 (100%)

5 (63%)

7 (70%)

6 (86%)

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 0049-3190-01)

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).

Visual Disturbances

Patients should be instructed that visual disturbances such as blurring and sensitivity to light may occur with the use of VFEND.

Photosensitivity

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).

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

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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.

LAB-0509-16.0

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:

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
pimozide
o
rifampin
o
efavirenz
o
ergotamine, dihydroergotamine (ergot alkaloids)
o
tolvaptan
o
venetoclax
o
quinidine
o
carbamazepine
o
ritonavir
o
St.John’s Wort (herbal supplement)
o
lurasidone
o
sirolimus
o
long-acting barbiturates like phenobarbital
o
rifabutin
o
naloxegol
o
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:
o
VFEND I.V. (intravenous infusion)
VFEND I.V. will be given to you by a healthcare provider over 1 to 3 hours.
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:
o
itchy skin
o
flu-like symptoms
o
yellowing of your eyes
o
nausea or vomiting
o
feeling very tired
vision changes. Symptoms of vision changes may include:
o
blurred vision
o
changes in the way you see colors
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.

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
sweating
o
trouble breathing
o
itching
o
feels like your heart is beating fast (tachycardia)
o
feel faint
o
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:
o
rash or hives
o
mouth sores
o
blistering or peeling of your skin
o
trouble swallowing or breathing
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
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
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
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 liquid at room temperature, 59°F to 86°F (15°C to 30°C). Do not refrigerate or freeze.
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.

Distributed byRoerigDivision of Pfizer IncNew York, NY 10017

Logo

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.

LAB-0513-13.0

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