Breast cancer

Active Ingredient: Fluorouracil

Indication for Fluorouracil

Population group: only adults (18 years old or older)

For this indication, competent medicine agencies globally authorize below treatments:

500-600 mg/m²

Route of admnistration


Defined daily dose

500 - 600 mg per m² of body surface area (BSA)

Dosage regimen

From 500 To 600 mg per m² of body surface area (BSA) once every day

Detailed description

5-fluorouracil is commonly used in chemotherapy regimens in combination with cyclophosphamide and methotrexate (CMF), or epirubicin, cyclophosphamide (FEC) or methotrexate and leucovorin (MFL). The usual dose range is 500-600 mg/m² body surface as an intravenous bolus and repeated every 3–4 weeks as necessary. In adjuvant treatment of primary invasive breast cancer, duration of treatment will usually continue for 6 cycles.

Active ingredient


Fluorouracil is an antineoplastic anti-metabolite. Anti-metabolites masquerade as purine or pyrimidine – which become the building blocks of DNA. They prevent these substances from becoming incorporated into DNA during the “S” phase (of the cell cycle), stopping normal development and division. Fluorouracil blocks an enzyme which converts the cytosine nucleotide into the deoxy derivative. In addition, DNA synthesis is further inhibited because Fluorouracil blocks the incorporation of the thymidine nucleotide into the DNA strand. Fluorouracil is used for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.

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