Vfend®(voriconazole)

VFEND may cause serious side effects including:• Vision changes – symptoms may include blurred vision and changes in the way you see colors• Serious skin reactions – symptoms may include rash or hives, mouth sores, blistering or peeling of your skin, trouble swallowing or breathing• Sensitivity to light or sun (photosensitivity) – which can increase your chance of skin toxicity and risk of faster skin aging and skin cancer• Liver problems – symptoms may include itchy skin, flu-like symptoms, yellowing of your eyes, nausea or vomiting, feeling very tired• Serious heart problems – VFEND may cause changes in your heart rate or rhythm, including your heart stopping• Allergic reactions• Kidney problems• Adrenal gland problems• Inflammation of the pancreas (pancreatitis)

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• CandidemiaIt 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.Do not take VFEND if you 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• finerenone• sirolimus• long-acting barbiturates like phenobarbital• rifabutin• naloxegol• ivabradine

Before you take VFEND, tell your healthcare provider 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 before starting VFEND)• Have low potassium levels, low magnesium levels, and low calcium levels• Have liver or kidney problems• Have trouble digesting dairy products, lactose (milk sugar), or regular table sugar (VFEND tablets contain lactose, VFEND oral suspension contains sucrose)• Are pregnant or plan to become pregnant (VFEND can harm your unborn baby – women who can become pregnant should use effective birth control while taking VFEND)• Are breastfeeding or plan to breastfeed

VFEND may be prescribed to you as:• VFEND I.V. (intravenous infusion) – will be given to you by a healthcare provider over 1 to 3 hours• VFEND tablets• VFEND oral suspensionTake 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.For VFEND oral suspension:• Your pharmacist will mix it for you• Shake the bottle for 10 seconds each time before you use it• Only use the oral dispenser that comes with your VFEND oral suspension• Do not mix with any other medicine, flavored liquid, or syrup

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.

The most common side effects of VFEND include:• Vision changes• Nausea• Rash• Vomiting• Headache• Hallucinations (seeing or hearing things that are not there)• Chills• Abnormal liver function tests• Fast heart beat (tachycardia)• FeverIn children, common side effects also include:• Diarrhea, low platelet counts, high blood pressure• Coughing, low blood pressure, swelling in the arms and legs• High blood sugar levels, nose bleeds, low blood potassium levels• Stomach pain, trouble breathing, dizziness, and kidney problems

• 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• Keep VFEND tablets and oral suspension in a tightly closed container• VFEND oral suspension should be thrown away (discarded) after 14 days• 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

Active ingredient: voriconazoleInactive 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