Voriconazole (Page 12 of 13)

16.2 Storage

Voriconazole for injection unreconstituted vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Voriconazole for injection 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° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° 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 voriconazole for injection.

Photosensitivity

Advise patients of the risk of photosensitivity (with or without concomitant methotrexate), accelerated photoaging, and skin cancer.
Advise patients that voriconazole for injection 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 voriconazole for injection.

Finished drug product Manufactured by Lek Pharmaceuticals d.d.

SI-1526, Ljubljana, Slovenia

for Sandoz Inc., Princeton, NJ 08540

PATIENT INFORMATION Voriconazole for Injection, for intravenous use

(vor-ah-KON-ah-zole)

Read the Patient Information that comes with voriconazole for injection 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 voriconazole for injection? Voriconazole for injection 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 voriconazole for injection is safe and effective in children younger than 2 years old.

Do not take voriconazole for injection if you:

are allergic to voriconazole or any of the ingredients in voriconazole for injection. See the end of this leaflet for a complete list of ingredients in voriconazole for injection.
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 voriconazole for injection, 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 voriconazole for injection.
have low potassium levels, low magnesium levels, and low calcium levels. Your healthcare provider may do blood tests before starting and during treatment with voriconazole for injection.
have liver or kidney problems. Your healthcare provider may do blood tests to make sure you can take voriconazole for injection.
are pregnant or plan to become pregnant. Voriconazole for injection 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 voriconazole for injection. 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 voriconazole passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take voriconazole for injection.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins and herbal supplements.Voriconazole for injection may affect the way other medicines work, and other medicines may affect how voriconazole for injection 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 voriconazole for injection?

Voriconazole for injection may be prescribed to you as:
Intravenous infusion
Voriconazole for injection will be given to you by a healthcare provider over 1 to 3 hours.
If you take too much voriconazole for injection, call your healthcare provider or go to the nearest hospital emergency room.

What should I avoid while taking voriconazole for injection?

You should not drive at night while taking voriconazole for injection. Voriconazole for injection 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 voriconazole for injection affects you.
Avoid direct sunlight. Voriconazole for injection 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 voriconazole for injection? Voriconazole for injection 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 or sun (photosensitivity). Voriconazole for injection can cause serious photosensitivity. There is an increased chance of skin toxicity while taking voriconazole for injection. 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. Voriconazole for injection 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. Voriconazole for injection may cause new or worse problems with kidney function, including kidney failure. Your healthcare provider should check your kidney function while you are taking voriconazole for injection. Your healthcare provider will decide if you can keep taking voriconazole for injection.
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:
Voriconazole for injection may cause reduced adrenal function (adrenal insufficiency).
Voriconazole for injection 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. Voriconazole for injection 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 voriconazole for injection 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 voriconazole for injection 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 voriconazole for injection. 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 voriconazole for injection?

Voriconazole for injection unreconstituted vials should be stored at 68° to 77°F (20° to 25°C).
Safely throw away medicine that is out of date or no longer needed.
Keep voriconazole for injection, as well as all other medicines, out of the reach of children.

General information about the safe and effective use of voriconazole for injection. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use voriconazole for injection for a condition for which it was not prescribed. Do not give voriconazole for injection 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 voriconazole for injection that is written for health professionals.

For more information, call Sandoz Inc. at 1-800-525-8747.

What are the ingredients in voriconazole for injection? Active ingredient: voriconazole.Inactive ingredients: sulfobutyl ether beta-cyclodextrin sodium.

The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Finished drug product Manufactured by Lek Pharmaceuticals d.d.

SI-1526, Ljubljana, Slovenia

for Sandoz Inc., Princeton, NJ 08540

This Patient Information has been approved by the U.S. Food and Drug Administration. Rev.: May 2023

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