5-FLUOROURACIL EBEWE 50mg / ml concentrate for solution for injection / infusion medication leaflet

L01BC02 • fluorouracil • Antineoplastic and immunomodulating agents | Antimetabolites | Pyrimidine analogues

Fluorouracil is a chemotherapy drug used to treat various types of cancer, including colorectal cancer, gastric cancer, breast cancer, pancreatic cancer, and esophageal cancer. It belongs to the class of antimetabolites and works by inhibiting the synthesis of DNA and RNA in cancer cells, leading to the cessation of cell division and, ultimately, cell death.

The mechanism of action of fluorouracil involves interference with pyrimidine metabolism, blocking the enzyme thymidylate synthase, which is essential for DNA synthesis. It is administered intravenously or as a topical cream (for dermatological conditions such as actinic keratosis or superficial basal cell carcinoma). In oncology, fluorouracil is often used in combination with other chemotherapy drugs to enhance efficacy.

While effective, fluorouracil can cause side effects. The most common include nausea, vomiting, diarrhea, stomatitis (inflammation of the mouth lining), hair loss, and myelosuppression (reduction in blood cell counts). In rare cases, more severe reactions may occur, such as cardiac toxicity, hand-foot syndrome (redness and pain in the palms and soles), or severe allergic reactions. Careful monitoring is essential to adjust the dose and prevent complications.

Fluorouracil must be administered under the strict supervision of an oncologist, and patients should be regularly monitored to assess their response to treatment and detect potential side effects. It is contraindicated in patients with hypersensitivity to the active substance, severe liver impairment, or severe myelosuppression. During treatment, patients should avoid excessive sun exposure and follow their doctor’s recommendations.