Class: Biological Therapy

Generic Name: Uridine Triacetate

Trade Name: Vistogard®

For which conditions is this drug approved? Vistogard is approved for the emergency treatment of adults and children who have received an overdose of one of the following chemotherapy medicines: fluorouracil or Xeloda® (capecitabine). Vistogard can be used in patients with or without symptoms of an overdose or in those with early signs of the following severe or life-threatening side effects: complications that affect the heart; early signs of severe or life threatening neurologic (central nervous system) problems; or certain unusually severe side effects the occur within four days (96 hours) after receiving treatment with fluorouracil or Xeloda.

What is the mechanism of action? Overdoses of fluorouracil or Xeloda can occur when the patient receives either drug at a higher dose or rate than intended. In addition, some people have genetic variations that put them at risk of overdose; and in some, their body doesn’t clear the drug effectively, or they are especially sensitive to the drug. Vistogard works by reducing the ability of excess fluorouracil or Xeloda to harm or kill healthy cells.

How is Vistogard typically given (administered)? Vistogard comes in granules and is taken orally (by mouth). The granules come in 10-gram packets that you mix with a small amount of soft food—such as 3 to 4 ounces of applesauce, pudding, or yogurt in a small container. The full treatment of Vistogard is 20 doses.

What are the side effects (occur in 10% to 29% of patients) of treatment with Vistogard?

• Vomiting

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Take Vistogard exactly as your doctor tells you to take it.
• If you vomit within two hours of taking a dose of Vistogard, take another full dose as soon as possible. Then take your next Vistogard dose at your next regularly scheduled time.
• If you miss a dose of Vistogard at your scheduled time, take the missed dose as soon as possible. Then take the next dose at the regularly scheduled time.
• Do not chew Vistogard granules. Take them mixed into soft food only.

 Are there any special precautions patients should be aware of before starting treatment?

• Take all 20 doses of Vistogard—even if you feel well and have no signs or symptoms of side effects.
• Before starting treatment with Vistogard, tell your healthcare provider about all of your medical conditions.
• Before starting treatment with Vistogard, tell your doctor if you are pregnant or plan to become pregnant. It is not known if Vistogard will harm your unborn baby.
• Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Vistogard passes into your breast milk. Talk to your doctor about the best way to feed your baby while you take

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.