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References
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
ISMP (2007) Fluorouracil Incident Root Cause Analysis
www.cancerboard.ab.ca/NR/rdonlyres/2FB61BC4-70CA-4E58-BDE1-1E54797BA47D/0/FluorouracilIncidentMay2007.pdf
Teva Parenteral Medicines, Inc. (2017). Adrucil
®
(fluorouracil injection, solution) Package Insert
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
Wellstat Therapeutics Corporation (2017) 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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Safety Information
In clinical studies, adverse reactions occurring in >2% of patients receiving VISTOGARD included vomiting (10%), nausea (5%), and diarrhea (3%).
One person receiving uridine triacetate experienced grade 3 nausea and vomiting.
VISTOGARD was discontinued for adverse reactions in 2 (1.4%) patients.
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Case Management
Enroll patients as soon as Vistogard
®
is initiated by calling Cardinal Health Specialty Pharmacy at
1-844-374-0604.
The Vistogard
®
Case Management Program is administered by Cardinal Health Specialty Pharmacy on behalf of Wellstat Therapeutics
Benefits of the Case Management Program include:
Facilitate a smooth pathway to transition patients from inpatient to outpatient care
Delivery to the appropriate setting or to the patient’s home
Provide instructions on dosing and administration
Adherence calls once per day to ensure completion of the full 20-dose course of therapy (1 dose, every 6 hours, for 5 days)
Assessment of eligibility for the Vistogard
®
Support Programs
Patient Assistance Program & Co-Pay Assistance
Prescription Form can be downloaded
here.