Approved for the emergency treatment of adults and children who have received an unintended overdose of 5-fluorouracil (5-FU) or capecitabine (Xeloda).
An oral agent.
Also intended for emergency use in patients who develop certain severe or life-threatening toxicities within 4 days of receiving these chemotherapies.
Some patients develop serious toxicity with these agents, even when they are administered at standard doses.
These drugs carry a risk for early severe toxicity in about 25% of patients after the first cycle of treatment.
Death can result from severe toxicity in about 0.4% to 0.6% of patients, amounting to some 1300 patients per year in the United States.
Toxicity is related to an asymptomatic deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme.
People who have a complete DPD deficiency have multiorgan toxicity, which can be fatal, therefore fluoropyrimidine drugs should be avoided.
In the ore common partial DPD deficiency, the fluoropyrimidine drugs can be used at reduced doses.
Works by blocking the cell damage and cell death caused by fluorouracil chemotherapy.
Should be taken as soon as possible after the overdose, whether or not they have symptoms, or early-onset of severe or life-threatening toxicity.
Not indicated for nonemergency use because it lessens the efficacy of fluorouracil.
Of patients treated with the antidote for overdose, 97% were still alive at 30 days, and of those treated with the antidote for early-onset severe or life-threatening toxicity, 89% were alive at 30 days.
Most common are diarrhea, vomiting, and nausea.
Signs of severe 5-FU and capecitabine toxicity early include gastrointestinal toxicities such as mucositis, central nervous system toxicities such as altered mental state, hematologic toxicities, and even cardiotoxicity.
Allows some patients to resume chemotherapy sooner following the resolution of the toxicity.