Product image of Capecitabine supplied by GNH India

Capecitabine

Active Ingredient:
Capecitabine
Origin:
EU

Capecitabine

Capecitabine is an oral tablet formulation containing the active ingredient capecitabine, an antimetabolite fluoropyrimidine used as a prescription (Rx) medication in the European Union. It is a prodrug that is converted to 5‑fluorouracil in tumor tissue, where it interferes with DNA and RNA synthesis, helping to control the growth of certain cancers. The product is supplied without a specific brand name and is administered under medical supervision.

Manufacturer / TM Owner

Pharmagen Cz S.R.O.

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Indications & Clinical Uses

Capecitabine is indicated for the treatment of several solid tumors, typically as part of combination chemotherapy regimens in adult patients.

  • Colorectal cancer, often in metastatic or adjuvant settings.
  • Breast cancer, especially HER2‑negative disease.
  • Gastric (stomach) cancer, including advanced stages.
  • Combination with oxaliplatin (CAPOX) for colorectal cancer.
  • Use in clinical trials for other gastrointestinal malignancies.
  • Pancreatic cancer in selected patients.
  • Anal canal carcinoma as part of multimodal therapy.

Side Effects

Capecitabine may cause a range of adverse effects, varying from mild to severe, that are related to its impact on rapidly dividing cells.

Common

  • Nausea and vomiting, often mild to moderate in intensity.
  • Diarrhea or loose stools, which may be intermittent.
  • Hand‑foot syndrome (palmar‑plantar erythrodysesthesia) causing redness, swelling, or tingling of the palms and soles.
  • Fatigue or generalized weakness affecting daily activities.
  • Decreased appetite leading to weight loss.

Serious

  • Severe neutropenia or leukopenia, increasing infection risk.
  • Thrombocytopenia (low platelet count) that may cause easy bruising or bleeding.
  • Severe or persistent diarrhea that can lead to dehydration and electrolyte imbalance.
  • Cardiotoxicity, including chest pain, shortness of breath, or arrhythmia.
  • Severe allergic reactions such as widespread rash, Stevens‑Johnson syndrome, or anaphylaxis.

Precautions & Warnings

Before initiating capecitabine therapy, several precautions and warnings should be considered to ensure patient safety and optimal treatment outcomes.

  • Assess renal and hepatic function, as impairment can increase drug exposure.
  • Monitor complete blood counts regularly to detect neutropenia or thrombocytopenia.
  • Evaluate for pre‑existing cardiac disease, given the risk of cardiotoxicity.
  • Counsel patients on recognizing early signs of hand‑foot syndrome.
  • Avoid use during pregnancy; discuss contraception with women of childbearing potential.
  • Adjust dose in elderly patients or those with poor performance status.

Avoid Interactions

Capecitabine may interact with other medicines, affecting its efficacy or increasing toxicity; known interactions are grouped below.

Avoid

  • Strong CYP2C9 inhibitors (e.g., fluconazole) that can raise capecitabine levels.
  • Anticoagulants such as warfarin, which may have enhanced anticoagulant effect.

Use with caution

  • Antiemetics containing dexamethasone, which may alter metabolism.
  • Other fluoropyrimidines or 5‑FU–based regimens, increasing risk of overlapping toxicity.
  • Drugs causing myelosuppression (e.g., carboplatin) that may exacerbate blood‑cell suppression.
  • Herbal supplements like St. John’s wort that induce hepatic enzymes.

Frequently Asked Questions

Capecitabine is an oral antimetabolite fluoropyrimidine classified as an antineoplastic agent used in cancer therapy.

Capecitabine is a prodrug that is metabolized to 5‑fluorouracil in tumor tissue, where it inhibits thymidylate synthase and incorporates into RNA and DNA, disrupting nucleic acid synthesis and cell proliferation.

Capecitabine is commonly prescribed for colorectal cancer, breast cancer, and gastric (stomach) cancer, often as part of combination chemotherapy regimens.

Capecitabine is administered orally in tablet form.

Capecitabine is contraindicated in pregnancy because its safety category is unknown; effective contraception is recommended for women of childbearing potential.

The most frequent side effects include nausea, vomiting, diarrhea, hand‑foot syndrome, fatigue, and loss of appetite.

Serious reactions can include severe neutropenia, thrombocytopenia, severe diarrhea leading to dehydration, cardiotoxicity, and severe allergic reactions such as Stevens‑Johnson syndrome.

Complete blood counts should be checked regularly, typically before each treatment cycle, to detect neutropenia or thrombocytopenia early.

Strong CYP2C9 inhibitors such as fluconazole can increase capecitabine levels, and concurrent use with warfarin may enhance anticoagulant effects; dose adjustments or alternative therapies may be needed.

Renal and hepatic function should be evaluated before starting therapy, and dose reductions are often required in patients with impaired kidney or liver function.

Yes, capecitabine is frequently combined with oxaliplatin (CAPOX regimen) and may be used with other agents, but overlapping toxicities should be monitored.

Patients should report symptoms promptly; dose modification, topical treatments, and supportive care measures are commonly employed to manage hand‑foot syndrome.

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GNH India Pharmaceuticals Limited

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Last updated:

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