Don’t wait—administer
VISTOGARD in patients with early-onset, severe or life-threatening toxicities within
96 hours of the last 5-FU or capecitabine dose1*
Survival outcomes with VISTOGARD
96%(130/135) survival in patients who received
VISTOGARD for 5-FU overdose or early onset, severe toxicity
In 2 open-label, single-arm trials (N=135), the primary
endpoint was survival at 30 days or until chemotherapy resumed.1 One hundred
seventeen patients received VISTOGARD for 5-FU (n=112) or capecitabine (n=5)
for early-onset, severe or life-threatening 5-FU toxicity.1
96% (130/135) survival in patients who received VISTOGARD for 5-FU overdose or
early-onset, severe 5-FU toxicity1
16% (n=25) survival in historical case reports of 5-FU overdose before VISTOGARD
became available1
Patients received only supportive care after overdose. All were overdosed by rate
(1.9 to 64 times the planned infusion rate)1
Of the 135 patients treated with VISTOGARD, there were 5 deaths due to 5-FU or
capecitabine toxicity (4%). Of these, 2 were treated >96 hours following the end of
5-FU administration1
33% (n=45) of patients resumed chemotherapy within 30 days1
Early onset was defined as severe toxicities that manifested during or within the 96 hours after 5-FU administration, or during a standard 14-day course of capecitabine (days 3-9).13
Preclinical data
Earlier treatment improved survival in animal studies1
Ma WW, Saif MW, El-Rayes, BF et al (2017), Emergency Use of
Uridine Triacetate for the Prevention and Treatment of Life-Threatening
5-Fluorouracil and Capecitabine Toxicity. Cancer 123(2):345-356
Ison G et al. (2016), FDA approval: Uridine triacetate for the treatment
ofpatients following fluorouracil or capecitabine overdose or exhibiting
early-onset severe toxicides following administration of these drugs. Clin
Cancer Res 22(18): 1-5
Brutcher E et al. (2018) Assessment and Treatment of Uncommon, Early-
onset, Severe Toxicides Associated With 5-Fluorouracil and
Capecitabine. Clin J Oncology Nursing 22 (6): 627-634
Polk A. et al. (2016). Incidence and risk factors for capecitabine-induced
symptomatic cardiotoxicity: A retrospective study o f452 consecutive
patients with metastatic breast cancer. BMJ Open, 6, e012798
Genentech, Inc. (2016). Xeloda® (capecitabine) Package Insert
Meulendijks, D et al. (2016) Renal function, body surface area, and age
are associated with risk of early-onset fluoropyrimidine-associated
oxicity in patients treated with capecitabine-based anticancer regimens
in daily clinical care. European Journal of Cancer, 54, 120-130
Froehlich TK et al. (2015). Clinical importance of risk variants in the
dihydropyrimidine dehydrogenase gene for the prediction of early-onset
fluoropyrimidine toxicity. International Journal of Cancer, 136, 730-739
Mitani S et al. (2017) Acute hyperammonemic encephalopathy after
fluoropyrimidine-based chemotherapy: A case series and review of the
literature Medicine 96:22(e6874)
Etienne-Grimaldi M-C et al. (2017) New advances in DPYD genotype
and risk of severe toxicity under capecitabine. PLOS ONE, 12, e0175998
Hamzic S et al. (2018) Come a long way, still a ways to go: from
predicting and preventing fluoropyrimidine toxicity to increased
efficacy? Pharmacogenomics 19(8):689-692 Published Online: 22 May
2018
Rodriguez RU. Public teleconference regarding licensing and
collaborative research opportunities for: methods and compositions
relating to detecting dihydropyrimidine dehydrogenase (DPD). Fed
Regist. 2008; 73(129):38233
Andre T et al. (2004) Oxaliplatin, fluorouracil, and leucovorin as
adjuvant treatment for colon cancer N Engl J Med. 2004;350: 2343-2351
Sara JD et al. (2018) 5-fluorouracil and cardiotoxicity: a review
Therapeutic Advances in Medical Oncology Vol 10: 1-18
Peng J et al. (2018) Cardiotoxicity of 5-fluorouracil and capecitabine in
Chinese patients: a prospective study Cancer Communications; 38(22):
1-7
Yeh KH and Cheng AL (1997) High-dose 5-fluorouracil infusional
herapy is associated with hyperammonaemia, lactic acidosis and
encephalopathy Brit. J Cancer 75(3): 464-465
Cordier P-Y et al. (2011). 5-FU-induced neurotoxicity in cancer patients
with profound DPD deficiency syndrome: A report of two cases. Cancer
Chemotherapy and Pharmacology, 68, 823-826
BTG International Inc. (2023) Vistogard (uridine triacetate) Oral Granules Package Insert
Garcia R et al. (2018) Prompt treatment with uridine triacetate improves
survival and reduces toxicity due to fluorouracil and capecitabine
overdose or dihydropyrimidine dehydrogenase deficiency Toxicology
and Applied Pharmacology 353 (2018) 67-73
Baldeo C et al. (2018) Uridine triacetate for severe 5-fluorouracil
toxicity in a patient with thymidylate synthase gene variation: Potential
pharmacogenomic implications (Case Report). SAGE Open Medical
Case Reports Volume 6: 1-4
Vaudo CE et al. (2016) Early-Onset 5-Fluorouracil Toxicity in a Patient
Negative for Dihydropyrimidine Dehydrogenase Mutations: The Clinical
Course of Reversal with Uridine Triacetate. Pharmacotherapy 36(11)
e178-e182
Santos C et al. (2017) The successful treatment of 5-fluorouracil (5-FU)
overdose in a patient with malignancy and HIV/AIDS with uridine
triacetate. American Journal of Emergency Medicine 35(5) 802.e7-
802.e8
Chu E (2014) Epidemiology and natural history of central venous access
device use and infusion pump function in the NO16966 trial Brit J Cancer
110, 1438-1445 doi: 10.1038/bjc
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