Vistogard

What is Vistogard?

• Vistogard (Uridine triacetate) is a pyrimidine analog used in the emergency treatment of patients who receive too much fluorouracil or capecitabine (types of anticancer drugs).
• It is also used in the emergency treatment of heart or central nervous system (CNS) toxicity or other serious side effects that occur within 4 days of ending treatment with fluorouracil or capecitabine.

Uridine triacetate

Uridine triacetate structure

What are the uses of this medicine?

Vistogard (Uridine triacetate) is a prescription medicine that contains uridine, a substance that is normally found in your body. Vistogard is used for emergency treatment of adults and children:

• after an overdose of fluorouracil or capecitabine with or without symptoms, or
• who have early signs of severe or life-threatening side effects that affect the heart, or early signs of severe or life threatening neurologic (central nervous system) problems, or certain unusually severe side effects within 4 days (96 hours) after receiving treatment with fluorouracil or capecitabine.

Limitations of use:

• Vistogard should only be used for the emergency treatment of side effects of fluorouracil or capecitabine, because it may decrease the effectiveness of these medicines.
• It is not known if Vistogard is safe and effective if started more than 4 days (96 hours) after the end of a dose of fluorouracil or capecitabine.

How does this medicine work?

• Uridine triacetate is an acetylated pro-drug of uridine.
• Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation.
• Uridine competitively inhibits cell damage and cell death caused by fluorouracil.
• Fluorouracil is a cytotoxic antimetabolite that interferes with nucleic acid metabolism in normal and cancer cells.
• Cells anabolize fluorouracil to the cytotoxic intermediates 5-fluoro-2'-deoxyuridine-5'-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP).
• FdUMP inhibits thymidylate synthase, blocking thymidine synthesis. Thymidine is required for DNA replication and repair.
• Uridine is not found in DNA.
• Fluorouracil cytotoxicity is the incorporation of its metabolite, FUTP, into RNA.
• This incorporation of FUTP into RNA is proportional to systemic fluorouracil exposure.
• Excess circulating uridine derived from Vistogard is converted into uridine triphosphate (UTP), which competes with FUTP for incorporation into RNA.

Who Should Not Use this medicine ?

Limitations of use:

• Vistogard should only be used for the emergency treatment of side effects of fluorouracil or capecitabine, because it may decrease the effectiveness of these medicines.
• It is not known if Vistogard is safe and effective if started more than 4 days (96 hours) after the end of a dose of fluorouracil or capecitabine.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Is this medicine FDA approved?

• Uridine triacetate was granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) and approved for use in the United States in 2015.

How should this medicine be used?

Recommended dosage: In Adults:

• 10 grams (1 packet) orally every 6 hours for 20 doses, without regard to meals.

In Pediatric:

• 6.2 grams/m2 of body surface area (not to exceed 10 grams per dose) orally every 6 hours for 20 doses, without regard to meals.

Administration:

• Vistogard comes in single-dose packets that contain 10 grams of orange-flavored granules.
• It is important that you take all 20 doses of Vistogard even if you feel well.
• The usual adult dose of Vistogard is 1 packet taken by mouth every 6 hours for a total of 20 doses.
• If you vomit within 2 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 the scheduled time, take the missed dose as soon as possible. Then take the next dose at the regularly scheduled time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Oral granules: 10 gram packets

This medicine is available in fallowing brand namesː

• Vistogard

What side effects can this medication cause?

The most common side effects of this medicine include:

• vomiting
• nausea
• diarrhea

• These are not all the possible side effects of Vistogard.

What special precautions should I follow?

Advise the patient or caregiver:

• The importance of taking all 20 doses, even if they feel well.
• That Vistogard can be taken mixed in food (applesauce, pudding or yogurt).
• That the Vistogard granules should not be chewed.
• It is not known if Vistogard passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Vistogard.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Vistogard will harm your unborn baby.

Can this medicine be used in children?

• The safety and effectiveness of Vistogard have been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: uridine triacetate
• Inactive Ingredients: ethylcellulose, Opadry Clear [proprietary dispersion of hydroxypropylmethylcellulose and Macrogol], and natural orange juice flavor.

Who manufactures and distributes this medicine?

• Manufactured for and distributed by Wellstat Therapeutics Corporation, Rockville, MD
• Vistogard® is a registered trademark of Wellstat Therapeutics Corporation.

What should I know about storage and disposal of this medication?

• Store Vistogard at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Vistogard
• FDA Vistogard

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