Vfend

DRUG DESCRIPTION

VFEND® (voriconazole), a triazole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is:

VFEND® (voriconazole) Structural Formula Illustration

Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4triazol-1-yl)-2-butanol with an empirical formula of C16H14F3N5O and a molecular weight of 349.3.

Voriconazole drug substance is a white to light-colored powder.

VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial.

VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see DOSAGE AND ADMINISTRATION].

VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, magnesium stearate and a coating containing hypromellose, titanium dioxide, lactose monohydrate and triacetin.

VFEND for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 g powder for oral suspension are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include colloidal silicon dioxide, titanium dioxide, xanthan gum, sodium citrate dihydrate, sodium benzoate, anhydrous citric acid, natural orange flavor, and sucrose.

What are the possible side effects of voriconazole (VFEND)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden behavior changes, problems with thinking or speech;
  • stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • fever, sore throat, and headache with a severe blistering, peeling, and red...

Read All Potential Side Effects and See Pictures of Vfend »

What are the precautions when taking voriconazole (Vfend)?

Before taking voriconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (e.g., itraconazole, ketoconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, recent chemotherapy, certain hereditary problems with digesting/absorbing the sugar galactose (e.g., galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption), untreated electrolyte imbalance (e.g., low calcium levels), heart problems (e.g., irregular heartbeat, cardiomyopathy).

Voriconazole may cause a condition...

Read All Potential Precautions of Vfend »


Vfend Consumer (continued)

SIDE EFFECTS: Nausea/vomiting, diarrhea, and headache may occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes (e.g., blurred vision, color vision changes), sensitivity of eyes to light (photophobia), bone/muscle/joint pain, weakness, mental/mood changes, muscle stiffness/spasm, restlessness, swelling of the ankles/feet, tiredness, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: fast/slow/irregular heartbeat, severe dizziness, fainting, change in the amount of urine, confusion, slurred speech, trouble breathing, chest/jaw/left arm pain, seizures.

Voriconazole may rarely cause serious (possibly fatal) liver problems. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes/skin, dark urine, persistent nausea/vomiting, stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Voriconazole can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking voriconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (e.g., itraconazole, ketoconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, recent chemotherapy, certain hereditary problems with digesting/absorbing the sugar galactose (e.g., galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption), untreated electrolyte imbalance (e.g., low calcium levels), heart problems (e.g., irregular heartbeat, cardiomyopathy).

Voriconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using voriconazole, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using voriconazole safely.

This drug may cause vision changes. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Do not drive at night.

Avoid alcoholic beverages since they can increase the risk of serious liver problems.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication is not recommended for use during pregnancy as it may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women using this medication use two effective forms of birth control (e.g., condoms and diaphragms with spermicide) while taking this medication. Consult your doctor.

It is not known if this medication passes into breast milk. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Vfend Patient Information Including Side Effects

Brand Names: VFEND

Generic Name: voriconazole (Pronunciation: vor i KON a zole)

  • What is voriconazole (Vfend)?
  • What are the possible side effects of voriconazole (Vfend)?
  • What is the most important information I should know about voriconazole (Vfend)?
  • What should I discuss with my healthcare provider before taking voriconazole (Vfend)?
  • How should I take voriconazole (Vfend)?
  • What happens if I miss a dose (Vfend)?
  • What happens if I overdose (Vfend)?
  • What should I avoid while taking voriconazole (Vfend)?
  • What other drugs will affect voriconazole (Vfend)?
  • Where can I get more information?

What is voriconazole (Vfend)?

Voriconazole is an antifungal medication.

Voriconazole is used to treat infections caused by yeast or other types of fungus.

Voriconazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of voriconazole (Vfend)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden behavior changes, problems with thinking or speech;
  • stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • uneven heart rate, chest pain, general ill feeling.

Less serious side effects may include:

  • vision problems such as blurred vision, eyes being more sensitive to light;
  • fever;
  • mild nausea, vomiting, or diarrhea;
  • headache; or
  • swelling in your hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about voriconazole (Vfend)?

Do not use voriconazole without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

There are many other medicines that can cause serious or life-threatening drug interactions with voriconazole. Tell your doctor about all the prescription and over-the-counter medications you use.

Before taking voriconazole, tell your doctor if you have heart rhythm problems, an electrolyte imbalance, liver or kidney disease, or a history of allergy to other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox).

Use voriconazole for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Voriconazole can cause problems with your vision. If you use this medicine for more than 28 days, you may need to have your eyes checked.

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