February 11, 2016

Vistogard® Approved for Life-Threatening Toxicities of Certain Chemotherapy Agents

By Anonymous User

The United States Food and Drug Administration (FDA) approved Vistogard (uridine triacetate) for the treatment of life-threatening toxicities caused by the chemotherapy drugs fluorouracil or capecitabine.

The approved indication is for the “emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or Xeloda (capecitabine), or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.”

The intravenous chemotherapy agent, fluorouracil, is commonly used for the treatment of gastrointestinal and breast cancers. Capecitabine is an oral formulation of fluorouracil also commonly used either alone or in combination for the treatment of certain cancers.

Fluorouracil has been used for decades in the treatment of cancers; however, an accidental overdose of fluorouracil or capecitabine – either due to dosage miscalculation, timing of drug errors, intravenous pump malfunctions, and/or accidental over-ingestion of capecitabine – can lead to life-threatening events and often, fatality. In addition, patients with the metabolic disorder called dihydropyrimidine dehydrogenas (DPD) deficiency are not able to tolerate either fluorouracil or capecitabine, requiring testing for the disorder prior to drug administration.

Vistogard is comprised of agents that do not allow the active components of fluorouracil or capecitabine to be absorbed in the body. Furthermore, it protects against cellular damage caused by the chemotherapy agents.

Two clinical trials were conducted to test the safety and effectiveness of Vistogard among patients who either had an overdose of fluorouracil or capecitabine, or experienced a severe or life-threatening toxicity from the chemotherapy agents within 4 days of receiving them.

The trials included 135 patients, both adults and pediatric patients, who received Vistogard for treatment of their severe toxicities from the chemotherapy.

  • 97% of all patients treated with Vistogard for an overdose were alive at 30 days.
  • 89% of all patients treated with Vistogard for early-onset severe or life-threatening toxicities from chemotherapy were alive at 30 days.
  • 33% of all patients were able to resume chemotherapy treatment in less than 30 days following Vistogard.
  • Patients should be administered Vistogard as soon as possible following an overdose and/or onset of symptoms from fluorouracil/uracil.

According to the FDA press release, Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research stated that “Today’s approval is a first-of-its-kind therapy that can potentially save lives following overdose or life-threatening toxicity from these chemotherapy agents.”

Reference: FDA press release. FDA approves first emergency treatment for overdose of certain types of chemotherapy. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476919.htm. Accessed February 2, 2016.


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