Uridine triacetate

What is Uridine triacetate?

• Uridine triacetate (Xuriden) is a pyrimidine analog for uridine replacement used to treat patients with hereditary orotic aciduria.

What are the uses of this medicine?

• This medicine is used in adult and pediatric patients for the treatment of hereditary orotic aciduria.

How does this medicine work?

• Uridine triacetate is an acetylated form of uridine.
• Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Xuriden.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage:

• The recommended starting dosage of oral Xuriden is 60 mg/kg once daily.

Increase the dosage of Xuriden to 120 mg/kg (not to exceed 8 grams) once daily for insufficient efficacy, such as occurrence of one of the following:

• Levels of orotic acid in urine remain above normal or increase above the usual or expected range for the patient
• Laboratory values (e.g., red blood cell or white blood cell indices) affected by hereditary orotic aciduria show evidence of worsening
• Worsening of other signs or symptoms of the disease

Administration

• Measure the dose using either a scale accurate to at least 0.1 gram, or a graduated teaspoon, accurate to the fraction of the dose to be administered.
• Once the measured dose has been removed from the Xuriden packet, discard the unused portion of granules.
• Do not use any granules left in the open packet.

Administration with Food

• Place 3 to 4 ounces of applesauce, pudding or yogurt in a small clean container.
• Mix the measured amount of granules in the applesauce, pudding or yogurt
• Swallow applesauce/pudding/yogurt immediately. Do not chew the granules. Do not save the applesauce/pudding/yogurt for later use.
• Drink at least 4 ounces of water.

Administration in Milk or Infant Formula

• Xuriden can be mixed with milk or infant formula instead of the soft foods described above for patients receiving up to 3/4 teaspoon (2 grams) of Xuriden. After weighing the dose of Xuriden:
• Pour 5 mL of milk or infant formula into a 30 mL medicine cup.
• Insert the tip of the oral syringe into the medicine cup and draw up 5 mL of milk/infant formula into the syringe.
• Hold the syringe with the tip pointing upward. Pull down on the plunger until the plunger reaches 10 mL. This will add air to the syringe.
• Place the cap over the tip of the syringe. Then invert the syringe so the syringe tip is pointing down, and remove the plunger.
• Pour the measured amount of Xuriden granules into the syringe barrel and reinsert the syringe plunger. Do not push up on the plunger.
• Gently swirl the syringe to mix the Xuriden granules with the liquid.
• Turn the syringe so the syringe tip is pointing up. Then remove the syringe cap and push up on the plunger until the plunger reaches the 5 mL mark. This will remove air from the syringe.
• Place the tip of the syringe in the patient's mouth between the cheek and gum at the back of the mouth. Gently push the plunger all the way down.
• Refill the syringe with another 5 mL of milk/infant formula.
• Gently swirl the syringe to rinse any remaining Xuriden granules from the syringe barrel.
• Place the tip of the syringe in the patient's mouth between the cheek and gum at the back of the mouth. Gently push the plunger all the way down.
• Follow with a bottle of milk or infant formula, if desired.

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

This medicine is available in fallowing doasage form:

• As Oral granules: 2 gram packets

This medicine is available in fallowing brand namesː

• Xuriden

What side effects can this medication cause?

• No adverse reactions were reported in clinical trials with Xuriden in patients with hereditary orotic aciduria.

What special precautions should I follow?

• None

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?

• There are no available data on Xuriden use in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient:

uridine triacetate

• Inactive ingredients:

ORANGE JUICE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED ETHYLCELLULOSE, UNSPECIFIED

Who manufactures and distributes this medicine?

• Packager: Wellstat Therapeutics Corporation

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

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

• Dailymed label info on Uridine triacetate
• FDA Uridine triacetate