Full Prescribing Information
Important Safety Information
For Patients
This site is intended for US healthcare professionals only.
Home
About Vistogard®
Dosing
Mechanism of Action (MOA)
Efficacy Data Summary
Safety
Data
Clinical
Pre-Clinical
Severe 5-FU Toxicity
5-FU Overdose
Resources
Patient Support Programs
Press Releases
Ordering Information
Contact
Register for updates
Register for updates
Your Contact Details
Title:
Mr
Ms
Mrs
Doctor
Professor
Other
First Name:
Last Name:
Your Role:
Country:
(select country)
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bosnia-Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Congo (Dem. Republic)
Cook Islands
Costa Rica
Croatia
Cuba
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
East Timor
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands (Malvinas)
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey and Alderney
Guinea
Guinea-Bissau
Guyana
Haiti
Heard and McDonald Islands
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Island of Man
Israel
Italy
Ivory Coast
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea (Democratic Republic of)
Korea (Republic of)
Kosovo
Kuwait
Kyrgyz Republic
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldavia
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territory
Panama
Papua-New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Re union
Republic of Dominica
Romania
Russian Federation
Rwanda
Saint Barthelemy
Saint Helena
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and South Sandwich Islands
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen Islands
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States Minor Outlying Islands
Uruguay
USA
Uzbekistan
Vanuatu
Vatican (Holy See)
Venezuela
Vietnam
Virgin Islands (British)
Virgin Islands (U.S.)
Wallis and Futuna Islands
Western Sahara
Yemen
Zambia
Zimbabwe
(select state)
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District of Columbia
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
Email Address:
Hospital Name:
Hospital Postcode:
Hospital Address:
Telephone:
We respect your privacy and do not sell, rent or loan any identifiable information collected on this site. Any information that you give us will be treated with the utmost care and security. It will not be used in ways to which you have not consented. From time to time Wellstat Therapeutics may use your registration details to contact you with additional information about VISTOGARD and other products and services of Wellstat Therapeutics that may be of interest to you. If you consent to receive this information, please select the “I accept” option below.
I Accept
Wellstat Medical Information
1-800 914-0071
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is for U.S. residents only. The information on this website should not take the place of talking with your doctor or health care professional.
×
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
×
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.
×
Case Management
Enroll patients as soon as Vistogard
®
is initiated by calling BioMatrix Specialty Pharmacy of Maryland at
1-844-374-0604.
The Vistogard
®
Case Management Program is administered by BioMatrix Specialty Pharmacy of Maryland 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.