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Oncology

Capecitabine medac

Product Description

Capecitabine is an orally administered cancer medicine that is userd in the treatment of colon cancer, metastatic colorectal cancer, advanced gastric cancer or locally advanced or metastatic breast cancer. Capecitabine medac is used on its own or with other cancer medicines. The active substance in Capecitabine medac, capecitabine, is a cytotoxic medicine (a medicine that kills rapidly dividing cells, such as cancer cells) that belongs to the group ‘anti-metabolites’. Capecitabine is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues. Fluorouracil is very similar to pyrimidine. Pyrimidine is part of the genetic material of cells (DNA and RNA). In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. As a result, it stops the growth of tumour cells and eventually kills them. 

Active Ingredient

Capecitabine

Mode of Action

Capecitabine is an orally administered precursor (prodrug) of 5‑fluorouracil (5-FU) and is activated in a three-step process in the liver and tumour tissue.

  1. After rapid absorption in the gastrointestinal tract, capecitabine in the liver is first metabolised by hepatic carboxylesterase to 5’-deoxy-5-fluorocytidine (5’-DFCR).
  2. 5’-DFCR is then converted to 5’-deoxy-5-fluorouridine (5’-DFUR) by cytidine deaminase, principally located in the liver and tumour tissues.
  3. The final catalytic activation occurs by thymidine phosphorylase, which is expressed in the tumour tissue in greater quantity. This transforms the 5’-DFUR into 5‑FU, resulting in cytostatic action affecting the tumour tissue in particular.

Indication

  • Adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer
  • Metastatic colorectal cancer
  • First-line treatment of advanced gastric cancer in combination with platinum based regimen
  • In combination with docetaxel for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline
  • Locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated

Dosage

Film-coated tablet:

  • 150 mg
  • 500 mg

Not all pack sizes may be marketed.

Materials

Abbreviated product information

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