Version May 2024
Fluoropyrimidine overdose/overexposure: Initiate within 96 hours after the end of fluorouracil or capecitabine administration: Oral: 10 g every 6 hours for 20 doses beginning as soon as possible after overdose or early-onset toxicity (Ma 2017). Administer the full course of 20 doses, even if the patient appears or feels well.
Off label: >96 hours after the end of fluorouracil or capecitabine administration (based on limited data): Uridine triacetate may be effective in managing severe GI, hematologic, cardiac, and neurologic toxicities when initiated beyond 96 hours following the end of fluorouracil/capecitabine administration. Case reports of use >96 hours post fluorouracil/capecitabine administration described improvement in severe toxicity associated with these agents; reports included a patient later determined to be homozygous for dihydropyrimidine dehydrogenase gene mutation, a heterozygous carrier, and another later found to have a thymidylate synthase gene variation (Baldeo 2018; Jacob 2022; Zurayk 2019).
Hereditary orotic aciduria: Oral: Initial: 60 mg/kg once daily; increase to 120 mg/kg (maximum: 8 g) for insufficient efficacy (eg, urine orotic acid levels remaining above normal or increasing above the usual/expected range for the patient; lab values affected by orotic acid [red or white blood cell indices] worsening; worsening disease signs/symptoms).
|
Patient weight |
60 mg/kga dose Dose in grams (dose in teaspoonsb) |
120 mg/kga dose Dose in grams (dose in teaspoonsb) |
|---|---|---|
|
Note: One Xuriden packet contains uridine triacetate 2 g. | ||
|
aDoses rounded (by the manufacturer) by weight category to achieve approximate dose level. | ||
|
bA 2 gram uridine triacetate (Xuriden) packet contains approximately 3/4 tsp. | ||
|
≤5 kg |
0.4 g (1/8 tsp) |
0.8 g (1/4 tsp) |
|
6 to 10 kg |
0.4 to 0.6 g (1/4 tsp) |
0.8 to 1.2 g (1/2 tsp) |
|
11 to 15 kg |
0.7 to 0.9 g (1/2 tsp) |
1.4 to 1.8 g (3/4 tsp or 1 entire packet) |
|
16 to 20 kg |
1 to 1.2 g (1/2 tsp) |
2 to 2.4 g (1 tsp) |
|
21 to 25 kg |
1.3 to 1.5 g (1/2 tsp) |
2.6 to 3 g (1 tsp) |
|
26 to 30 kg |
1.6 to 1.8 g (3/4 tsp or 1 entire packet) |
3.2 to 3.6 g (11/4 tsp) |
|
31 to 35 kg |
1.9 to 2.1 g (3/4 tsp or 1 entire packet) |
3.8 to 4.2 g (11/2 tsp or 2 entire packets) |
|
36 to 40 kg |
2.2 to 2.4 g (1 tsp) |
4.4 to 4.8 g (13/4 tsp) |
|
41 to 45 kg |
2.5 to 2.7 g (1 tsp) |
5 to 5.4 g (2 tsp or 3 entire packets) |
|
46 to 50 kg |
2.8 to 3 g (1 tsp) |
5.6 to 6 g (2 tsp or 3 entire packets) |
|
51 to 55 kg |
3.1 to 3.3 g (11/4 tsp) |
6.2 to 6.6 g (21/4 tsp) |
|
56 to 60 kg |
3.4 to 3.6 g (11/4 tsp) |
6.8 to 7.2 g (21/2 tsp) |
|
61 to 65 kg |
3.7 to 3.9 g (11/2 tsp or 2 entire packets) |
7.4 to 7.8 g (21/2 tsp) |
|
66 to 70 kg |
4 to 4.2 g (11/2 tsp or 2 entire packets) |
8 g (23/4 tsp or 4 entire packets) |
|
71 to 75 kg |
4.3 to 4.5 g (11/2 tsp or 2 entire packets) |
8 g (23/4 tsp or 4 entire packets) |
|
>75 kg |
6 g (2 tsp or 3 entire packets) |
8 g (23/4 tsp or 4 entire packets) |
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Uridine triacetate: Pediatric drug information")
Note: Package (packet) size of products is different (Vistogard: 10 g/packet, Xuridine: 2 g/packet of uridine triacetate); use caution with product selection and calculations.
Fluoropyrimidine (fluorouracil/ capecitabine ) overdose/overexposure: Children and Adolescents: Vistogard: Oral: 6.2 g/m2 (maximum dose: 10 g/dose [1 packet]) every 6 hours for 20 doses beginning as soon as possible after overdose or early-onset toxicity within 96 hours after the end of fluorouracil or capecitabine administration. May be dosed as g or teaspoon; measure dose using either a scale (accurate to at least 0.1 g) or a graduated teaspoon (accurate to 1/4 teaspoon). See table for BSA range dose recommendations (including rounding) for g and teaspoon doses. Note: Administer the full course of 20 doses, even if the patient appears or feels well.
|
Patient BSA |
Dose of Uridine Triacetate (Vistogard) 6.2 g/m2/dosea | |
|---|---|---|
|
Dose in grams |
Dose in graduated teaspoons | |
|
Note: One Vistogard packet contains uridine triacetate 10 g. | ||
|
aDoses rounded by BSA to achieve approximate dose; administer each dose every 6 hours for 20 doses. bMay use 1 entire 10 g packet without weighing or measuring. Do not exceed 10 g/dose | ||
|
0.34 to 0.44 m2 |
2.1 to 2.7 g |
1 tsp |
|
0.45 to 0.55 m2 |
2.8 to 3.4 g |
1 1/4 tsp |
|
0.56 to 0.66 m2 |
3.5 to 4.1 g |
1 1/2 tsp |
|
0.67 to 0.77 m2 |
4.2 to 4.8 g |
1 3/4 tsp |
|
0.78 to 0.88 m2 |
4.9 to 5.4 g |
2 tsp |
|
0.89 to 0.99 m2 |
5.5 to 6.1 g |
2 1/4 tsp |
|
1 to 1.1 m2 |
6.2 to 6.8 g |
2 1/2 tsp |
|
1.11 to 1.21 m2 |
6.9 to 7.5 g |
2 3/4 tsp |
|
1.22 to 1.32 m2 |
7.6 to 8.1 g |
3 tsp |
|
1.33 to 1.43 m2 |
8.2 to 8.8 g |
3 1/4 tsp |
|
≥1.44 m2 |
10 g b |
1 full packetb |
Hereditary orotic aciduria: Infants, Children, and Adolescents: Oral: Xuridine: Initial: 60 mg/kg once daily; may increase to 120 mg/kg (maximum daily dose: 8 g/day ) for insufficient efficacy (eg, urine orotic acid levels remaining above normal or increasing above the usual/expected range for the patient; lab values affected by orotic aciduria [red or white blood cell indices] worsening; worsening disease signs/symptoms). May be dosed as g or teaspoon; measure dose using either a scale (accurate to at least 0.1 g) or a graduated teaspoon (accurate to the fraction being measured). See table for weight-band dosing (including dose rounding).
|
Patient weight |
60 mg/kga dose Dose in grams (dose in teaspoonsb) |
120 mg/kga dose Dose in grams (dose in teaspoonsb) |
|---|---|---|
|
aDoses rounded (by the manufacturer) by weight category to achieve approximate dose level | ||
|
bA 2 gram uridine triacetate (Xuriden) packet contains approximately 3/4 tsp | ||
|
≤5 kg |
0.4 g (1/8 tsp) |
0.8 g (1/4 tsp) |
|
6 to 10 kg |
0.4 to 0.6 g (1/4 tsp) |
0.8 to 1.2 g (1/2 tsp) |
|
11 to 15 kg |
0.7 to 0.9 g (1/2 tsp) |
1.4 to 1.8 g (3/4 tsp or 1 entire packet) |
|
16 to 20 kg |
1 to 1.2 g (1/2 tsp) |
2 to 2.4 g (1 tsp) |
|
21 to 25 kg |
1.3 to 1.5 g (1/2 tsp) |
2.6 to 3 g (1 tsp) |
|
26 to 30 kg |
1.6 to 1.8 g (3/4 tsp or 1 entire packet) |
3.2 to 3.6 g (11/4 tsp) |
|
31 to 35 kg |
1.9 to 2.1 g (3/4 tsp or 1 entire packet) |
3.8 to 4.2 g (11/2 tsp or 2 entire packets) |
|
36 to 40 kg |
2.2 to 2.4 g (1 tsp) |
4.4 to 4.8 g (13/4 tsp) |
|
41 to 45 kg |
2.5 to 2.7 g (1 tsp) |
5 to 5.4 g (2 tsp or 3 entire packets) |
|
46 to 50 kg |
2.8 to 3 g (1 tsp) |
5.6 to 6 g (2 tsp or 3 entire packets) |
|
51 to 55 kg |
3.1 to 3.3 g (11/4 tsp) |
6.2 to 6.6 g (21/4 tsp) |
|
56 to 60 kg |
3.4 to 3.6 g (11/4 tsp) |
6.8 to 7.2 g (21/2 tsp) |
|
61 to 65 kg |
3.7 to 3.9 g (11/2 tsp or 2 entire packets) |
7.4 to 7.8 g (21/2 tsp) |
|
66 to 70 kg |
4 to 4.2 g (11/2 tsp or 2 entire packets) |
8 g (23/4 tsp or 4 entire packets) |
|
71 to 75 kg |
4.3 to 4.5 g (11/2 tsp or 2 entire packets) |
8 g (23/4 tsp or 4 entire packets) |
|
>75 kg |
6 g (2 tsp or 3 entire packets) |
8 g (23/4 tsp or 4 entire packets) |
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Gastrointestinal: Vomiting (10%), nausea (5%), diarrhea (3%)
There are no contraindications listed in the manufacturer's labeling.
There are no warnings listed in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Packet, Oral:
Vistogard: 10 g (4 ea, 20 ea) [orange flavor]
Xuriden: 2 g (1 ea, 30 ea) [orange flavor]
No
Pack (Vistogard Oral)
10 g (per each): $5,056.80
Pack (Xuriden Oral)
2 g (per each): $945.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Fluorouracil accidental overdose/overexposure: Uridine triacetate (formerly called vistonuridine) is available through select specialty pharmacies. Procurement information is available from Wellstat Therapeutics at 1-800-914-0071 or https://www.vistogard.com/Professional/How-to-Order.
Oral:
Granules: Measure the prescribed 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 (accurate to 1/4 teaspoonful). Discard the unused portion of granule packet after measuring out the dose. Do not chew granules. May be administered without regard to meals (food does not have an effect on uridine exposure).
Fluoropyrimidine overdose/overexposure: Administer orally; begin as soon as possible after overdose or early-onset toxicity within 96 hours following the end of fluorouracil or capecitabine overdose/overexposure (Ma 2017). Based on limited data, uridine triacetate may be effective in managing severe toxicities when initiated beyond 96 hours (off-label) after fluorouracil or capecitabine administration (Baldeo 2018; Jacob 2022; Zurayk 2019). Administer within 30 minutes of preparation (in soft food such as applesauce, pudding, or yogurt), followed by at least 120 mL water. If patient vomits within 2 hours of taking dose, administer another complete dose as soon as possible after vomiting episode. If a dose is missed, administer the missed dose as soon as possible and then administer the next dose at the regularly scheduled time. If necessary to administer through a nasogastric or gastrostomy tube (due to stomatitis or mucositis), mix with thickening agent (see Preparation for Administration); following administration, flush tube with water. Administer the full treatment course (all 20 doses), even if the patient appears or feels well.
Hereditary orotic aciduria: May be mixed in food (ie, 3 to 4 ounces of applesauce, pudding, or yogurt) and administered immediately, followed by drinking at least 120 mL water. Do not chew the granules. Do not save for later use.
Granules: Measure the prescribed 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. Discard the unused portion of granules after measuring out the dose. Do not chew granules. May be administered without regard to meals (food does not have an effect on uridine exposure).
Fluoropyrimidine overdose/overexposure: Vistogard: Administer orally; begin as soon as possible after overdose or early-onset toxicity within 96 hours following the end of fluorouracil or capecitabine overdose/overexposure (Ma 2017). Administer the full treatment course (all 20 doses), even if patient appears or feels well.
Oral: Mix each dose with 3 to 4 ounces of soft food (applesauce, pudding, or yogurt). Administer within 30 minutes of preparation (in soft food such as applesauce, pudding, or yogurt); do not chew granules. Following administration, drink at least 4 ounces (120 mL) of water. If patient vomits within 2 hours of taking dose, administer another complete dose as soon as possible after vomiting episode and then administer the next dose at the regularly scheduled time. If a dose is missed, administer the missed dose as soon as possible and then administer the next dose at the regularly scheduled time.
Nasogastric (NG) or gastrostomy tube administration: If necessary to administer through a nasogastric or gastrostomy tube (due to stomatitis or mucositis), mix with thickening agent (see Preparation for Administration); following administration, flush tube with water.
Hereditary orotic aciduria: Xuriden:
Oral administration with food: Mix each dose with 3 to 4 ounces of applesauce, pudding, or yogurt in a small clean container and administer immediately; do not chew the granules. Do not save applesauce, pudding, or yogurt mixture for later use. Following administration drink at least 4 ounces (120 mL) of water.
Oral administration in milk or infant formula: May be mixed with milk or infant formula for patients receiving a dose of up to 2 grams (3/4 teaspoon). See Preparation for Administration for oral syringe preparation instructions. Place the tip of the oral 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 remaining uridine triacetate 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. May follow with a bottle of milk or infant formula.
Fluoropyrimidine overdose/overexposure: Emergency treatment of fluorouracil or capecitabine overdose (regardless of the presence of symptoms) or early-onset severe or life-threatening cardiac or CNS toxicity and/or early-onset unusually severe adverse reactions (eg, GI toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration (in adult and pediatric patients).
Limitations of use: Uridine triacetate is not recommended for nonemergent treatment of adverse reactions associated with fluorouracil or capecitabine (because it may diminish efficacy of these medications). Safety and efficacy of uridine triacetate initiated >96 hours following the end of fluorouracil or capecitabine administration have not been established.
Hereditary orotic aciduria: Treatment of hereditary orotic aciduria in adult and pediatric patients.
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies. Information related to the use of uridine triacetate for the treatment of hereditary orotic aciduria and fluoropyrimidine overdose/severe (life-threatening) toxicity during pregnancy is limited; monitor closely, dose adjustments may be required (Bensen 1991). In general, medications used as antidotes should take into consideration the health and prognosis of the mother; antidotes should be administered to pregnant patients if there is a clear indication for use and should not be withheld because of fears of teratogenicity (Bailey 2003).
It is not known if uridine triacetate is present in breast milk.
According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Fluoropyrimidine overdose/overexposure: CBC with differential; gastrointestinal toxicity (Hidalgo 2000).
Hereditary orotic aciduria: Urine orotic acid level, RBC or WBC indices.
Uridine triacetate is an acetylated form of uridine which is deacetylated following administration to provide circulating uridine in patients with hereditary orotic aciduria. In patients with fluorouracil overdose or overexposure, uridine competes with fluorouridine triphosphate, a fluorouracil metabolite for incorporation into RNA of hematopoietic progenitor cells and gastrointestinal mucosal cells to reduce fluorouracil toxicity in normal tissues (Hidalgo 2000; Ma 2017).
Onset: Hereditary orotic aciduria: Oral exogenous uridine improves hematologic abnormalities within 2 to 3 weeks; urinary orotic acid reduced within 1 to 2 weeks of initiating therapy.
Duration of action: Hereditary orotic aciduria: Hematologic abnormalities and orotic aciduria return within days up to 2 to 3 weeks after discontinuation or dose reduction.
Distribution: Distributes into cells; crosses the blood brain barrier
Metabolism: Deacetylated (by nonspecific esterases) to uridine and free acetate (Hidalgo 2000)
Half-life elimination: 2 to 2.5 hours
Time to peak: 2 to 3 hours
Excretion: Urine; also catabolic metabolism in tissues.
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