The U.S. Meals and Drug Administration (FDA) has issued an up to date security communication relating to two generally used chemotherapy medicine, Xeloda (capecitabine) and fluorouracil (5-FU), in response to the regulatory company. The replace focuses on dangers related to a uncommon genetic situation generally known as dihydropyrimidine dehydrogenase (DPD) deficiency, which may considerably improve the probability of extreme or life-threatening negative effects from these therapies.
Xeloda and 5-FU are broadly used to deal with a number of cancers, together with colorectal, breast, gastric, esophageal, and pancreatic cancers. The FDA is emphasizing the significance of testing for particular genetic variants within the DPYD gene earlier than beginning remedy, until quick remedy is required. These labeling adjustments are supposed to assist clinicians higher determine sufferers at elevated threat and to enhance remedy security.
Key labeling adjustments for Xeloda and fluorouracil
A serious replace seems within the Boxed Warning, probably the most outstanding security warning required by the FDA. The warning now highlights the danger of great adversarial reactions or loss of life in sufferers with full DPD deficiency and advises genetic testing for DPYD variants previous to remedy initiation when potential.
As well as, a brand new subsection has been added to the Dosage and Administration part instructing clinicians to keep away from utilizing Xeloda or 5-FU in sufferers recognized to have sure homozygous or compound heterozygous DPYD variants that lead to full absence of DPD exercise. For sufferers with partial DPD deficiency, the labeling recommends individualized dosing primarily based on medical judgment.
The Warnings and Precautions part additionally reinforces the significance of DPYD genetic testing earlier than beginning remedy. These updates purpose to cut back the danger of early, extreme toxicities by figuring out susceptible sufferers earlier than publicity to fluoropyrimidine chemotherapy.
What’s DPD deficiency? Why does it matter?
DPD deficiency is a genetic situation brought on by variants within the DPYD gene, which encodes the enzyme dihydropyrimidine dehydrogenase. This enzyme is answerable for breaking down greater than 80% of fluorouracil within the physique. When DPD exercise is absent or diminished, fluorouracil and Xeloda can accumulate to harmful ranges.
Sufferers with full DPD deficiency have little to no enzyme exercise and face a excessive threat of early-onset toxicities, together with extreme diarrhea, mouth sores (mucositis), low white blood cell counts (neutropenia), and neurologic problems. In some instances, these reactions will be deadly. Sufferers with partial DPD deficiency can also be at elevated threat, though the severity can fluctuate.
As a result of DPD deficiency isn’t simply recognized primarily based on signs alone, genetic testing performs an necessary function in recognizing sufferers who might have different therapies or dose changes.
How are testing and remedy selections are made?
The up to date labeling instructs healthcare suppliers to check sufferers for recognized DPYD genetic variants earlier than beginning Xeloda or 5-FU, until remedy should start instantly. If testing identifies full DPD deficiency, use of those medicine must be prevented, as no protected dose has been established for these sufferers.
For people with partial DPD deficiency, clinicians might think about decrease beginning doses with cautious monitoring. The FDA notes that remedy selections must be individualized, considering the affected person’s total well being, most cancers sort, and urgency of remedy.
Sufferers are inspired to debate genetic testing with their oncology workforce and to ask whether or not DPYD testing has been carried out previous to beginning remedy.
Who could also be affected and extra security info
Xeloda and 5-FU are prescribed throughout a variety of most cancers varieties, that means many sufferers may very well be impacted by these updates. The FDA will proceed monitoring security knowledge and should think about extra regulatory actions as new info turns into out there.
Though these medicine stay necessary parts of most cancers remedy, the up to date labeling underscores the rising function of genetic testing in bettering security and personalizing care.
References
- “Security labeling replace for capecitabine and fluorouracil (5-FU) on dangers related to dihydropyrimidine dehydrogenase (DPD) deficiency,” by the U.S. Meals and Drug Administration. Information launch; Feb. 5, 2026.
Editor’s word: This text is for informational functions solely and isn’t an alternative choice to skilled medical recommendation, as your personal expertise shall be distinctive. Use this text to information discussions along with your oncologist. Content material was generated with AI and reviewed by a human editor.
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