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First Emergency Treatment for Certain Chemotherapy Overdoses Wins FDA Approval

Medication treats overdose with fluorouracil or capecitabine

The FDA has cleared uridine triacetate (Vistogard, Wellstat Therapeutics) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.

Fluorouracil (taken by infusion) and capecitabine (taken orally) are similar types of chemotherapy that have been used for decades to treat several types of cancer, including breast and gastrointestinal cancers. An overdose of fluorouracil or capecitabine is rare, but when it occurs, the effects are serious and can be fatal.

Uridine triacetate, taken orally, blocks cell damage and cell death caused by fluorouracil chemotherapy. Patients should take uridine as soon as possible after the overdose (whether or not they have symptoms) or at early onset (within four days) of severe or life-threatening toxicity. The patient’s health care provider will determine when the patient should return to the prescribed chemotherapy after treatment with uridine.

The efficacy and safety of uridine triacetate were studied in 135 adult and pediatric cancer patients who were treated in two separate trials and had received an overdose of flourouracil or capecitabine, or had early-onset, unusually severe or life-threatening toxicities within 96 hours after receiving flourouracil (not due to an overdose). The studies’ primary endpoint was survival at 30 days or until chemotherapy could resume if prior to 30 days. Of those who were treated with uridine for overdose, 97% were still alive at 30 days. Of those treated with uridine for early-onset severe or life-threatening toxicity, 89% were alive at 30 days. In both studies, 33% of patients resumed chemotherapy in fewer than 30 days.

Uridine triacetate is not recommended for treating nonemergency adverse events associated with flourouracil or capecitabine because uridine may reduce the efficacy of these drugs. The safety and efficacy of uridine initiated more than 96 hours after the end of treatment with flourouracil or capecitabine have not been established.

The most common adverse events associated with treatment with uridine triacetate included diarrhea, vomiting, and nausea.

The FDA granted uridine triacetate an orphan drug designation, a fast track designation, and priority review.

Source: FDA; December 11, 2015.

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