Uridine-triacetate Oral Granules

VISTOGARD® is indicated for the emergency treatment of adult and pediatric patients:

• following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or
• who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

Limitations Of Use

• VISTOGARD is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.
• The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.

Dosage Forms And Strengths

Oral granules: 10 grams of orange-flavored, white-to-off-white, oral granules (95% w/w) in singledose packets.

Storage And Handling

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

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

Manufactured by: Wellstat Therapeutics Corporation, Rockville, MD 20850. Revised: Feb 2017

No Information Provided

XURIDEN (uridine triacetate) oral granules is a pyrimidine analog indicated for uridine replacement therapy. Uridine triacetate has the chemical designation (2',3',5'-tri-O-acetyl-ß-D-ribofuranosyl)-2,4(1H,3H)-pyrimidinedione. The molecular weight is 370.3 and it has an empirical formula of C15H18N2O9. The structural formula is:

Each single-use 2 gram packet of XURIDEN orange-flavored oral granules (95% w/w) contains 2 grams of uridine triacetate and the following inactive ingredients: ethylcellulose (0.062 grams), Opadry Clear [proprietary dispersion of hydroxypropylmethylcellulose and Macrogol] (0.015 grams), and natural orange juice flavor (0.026 grams).

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions and using a wide range of doses, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of XURIDEN was assessed in 4 patients with hereditary orotic aciduria ranging in age from 3 to 19 years (3 male, 1 female) who received 60 mg/kg of XURIDEN once daily for six weeks. The patients continued to receive XURIDEN for at least 9 months at dosages of up to 120 mg/kg once daily. No adverse reactions were reported with XURIDEN.

Included as part of the "PRECAUTIONS" Section

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

Side effects have not been reported with Xuriden.

Side effects with Vistogard that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• nausea/vomiting

Take this medicine by mouth. Follow the directions on the prescription label. Use the special graduated teaspoon or scale to measure your dose. Household spoons are not accurate. Do not chew this medicine. Mix Xuriden with soft food, milk, or infant formula. Mix Vistogard with soft food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

They need to know if you have any of these conditions:

• an unusual or allergic reaction to uridine triacetate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medicine.

Keep out of the reach of children. Store Xuriden at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Store Vistogard at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away the unused portion of granules in a packet after measuring the dose. Throw away any unused medicine after the expiration date.