Vistogard

Generic name: uridine triacetate
Drug classes: Antidotes,

What is Vistogard?

Vistogard is a prescription medicine that is used to treat fluorouracil or capecitabine overdose.

It is used to treat very bad or life-threatening side effects caused by fluorouracil or capecitabine.

Description

VISTOGARD oral granules contain the active ingredient uridine triacetate which is a pyrimidine analog. The chemical name for uridine triacetate is (2′,3′,5′-tri-O-acetyl-β-D-ribofuranosyl)-2,4(1H,3H)-pyrimidinedione. The molecular weight is 370.3 grams/mole and it has an empirical formula of C15H18N2O9. The structural formula is:

Each single-dose 10 gram packet of VISTOGARD orange-flavored oral granules (95% w/w) contains 10 grams of uridine triacetate and the following inactive ingredients: ethylcellulose (0.309 grams), Opadry® Clear [proprietary dispersion of hydroxypropylmethylcellulose and Macrogol] (0.077 grams), and natural orange juice flavor (0.131 grams).

Mechanism of Action

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.

The second source of 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.

Before taking Vistogard, tell your doctor:

• If you are allergic to Vistogard; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Vistogard with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Vistogard?

• Tell all of your health care providers that you take Vistogard. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Vistogard while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Vistogard best taken?

Use Vistogard as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will tell you how to take Vistogard. Be sure you know how much to take, how often to take Vistogard, and how to store Vistogard. If your doctor does not tell you how to use Vistogard or if you are not sure how to use it, talk with your doctor.
• Throw away any part of the packet not used after use.
• Mix granules with 3 to 4 ounces (90 to 120 mL) of applesauce, pudding, or yogurt.
• Do not chew Vistogard.
• Drink at least 4 ounces (120 mL) of water.
• Keep taking Vistogard as you have been told by your doctor or other health care provider, even if you feel well.
• Take with or without food.
• Take your dose within 30 minutes after mixing. Throw away any part not used within 30 minutes of mixing.
• If you throw up within 2 hours of taking Vistogard, take 1 more dose.
• Those who have feeding tubes may use Vistogard. Use as you have been told. Flush the feeding tube after Vistogard is given.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Vistogard that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Vistogard?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How supplied/stored

• VISTOGARD orange-flavored oral granules (95% w/w) are available in single-dose packets containing 10 grams of uridine triacetate.

  NDC Number	Package Configuration
  69468-151-20	Course of therapy package:
  	1 carton containing 20 single-dose packets of VISTOGARD
  69468-151-04	24-Hour Pack:
  	1 carton containing 4 single-dose packets of VISTOGARD

   

  Store at USP controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30 °C (59° to 86°F).

Label

• NDC 69468-151-20
  Rx Only
• VISTOGARD® 10 g
  (uridine triacetate) oral granules
• Carton contains 20 x 10 gram packets
• Wellstat Therapeutics™
  CORPORATION