Oral fluoropyrimidine prodrug (specialist) Pregnancy: Contraindicated during pregnancy and lactation. May cause fetal harm (embryolethality and teratogenicity in animals); women of childbearing potential should avoid becoming pregnant and use effective contraception during treatment and for 6 months after the last dose.

Capecitabine

Brand names: Xeloda

Capecitabine is an oral fluoropyrimidine cytotoxic prodrug of fluorouracil, used in the treatment of colorectal, breast and gastric cancers.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Monotherapy: 1250 mg/m2 twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period

Route: Oral

Frequency: Twice daily for 14 days, then 7-day rest period (21-day cycle)

Should only be prescribed by a qualified physician experienced in anti-neoplastic medicinal products. Monotherapy indication: adjuvant treatment of stage III colon cancer (recommended for a total of 6 months), metastatic colorectal cancer, or locally advanced/metastatic breast cancer. Combination therapy (colon, colorectal, gastric): reduce starting dose to 800-1000 mg/m2 twice daily for 14 days then 7-day rest, or 625 mg/m2 twice daily when given continuously; with irinotecan, 800 mg/m2 twice daily for 14 days + irinotecan 200 mg/m2 on day 1. Breast cancer with docetaxel: 1250 mg/m2 twice daily for 14 days + docetaxel 75 mg/m2 IV every 3 weeks. Dose is calculated by body surface area (see SPC tables 1 and 2 for tablet counts). Toxicity managed by treatment interruption or dose reduction (Grade 2/3/4 schedule); once reduced, the dose should not be increased later; doses omitted for toxicity are not replaced.

Dose adjustments

Renal

Contraindicated in severe renal impairment (creatinine clearance below 30 mL/min).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

History of severe and unexpected reactions to fluoropyrimidine therapy
Hypersensitivity to capecitabine, its excipients, or fluorouracil
Known complete dihydropyrimidine dehydrogenase (DPD) deficiency
During pregnancy and lactation
Severe leukopenia, neutropenia, or thrombocytopenia
Severe hepatic impairment
Severe renal impairment (creatinine clearance below 30 mL/min)
Recent or concomitant treatment with brivudine

Side effects

Diarrhoea
Nausea and vomiting
Abdominal pain, stomatitis
Hand-foot syndrome (palmar-plantar erythrodysesthesia)
Fatigue, asthenia, anorexia

Interactions

Vitamin K antagonists / coumarin anticoagulants — monitor INR more frequently and adjust dose as appropriate
Phenytoin — closely monitor phenytoin levels and adjust the phenytoin dose
CYP2C9 substrates — closely monitor for adverse reactions
Brivudine — contraindicated (recent or concomitant use)
Leucovorin (folinic acid) / allopurinol — leucovorin enhances fluorouracil toxicity; avoid concomitant allopurinol (may reduce efficacy)

Clinical monograph

How it works

It is converted enzymatically, preferentially within tumour tissue, to fluorouracil, which inhibits thymidylate synthase and disrupts DNA and RNA synthesis.

Prescribing in practice

Patients with dihydropyrimidine dehydrogenase (DPD) deficiency are at risk of severe, potentially fatal toxicity; test for DPD deficiency before starting and it is contraindicated in complete deficiency.
Coadministration with warfarin can markedly potentiate anticoagulation and requires close INR monitoring.
Hand-foot syndrome, diarrhoea and stomatitis are common and may necessitate treatment interruption.

Monitoring

Monitor full blood count, hydration status and for signs of toxicity such as diarrhoea, mucositis and hand-foot syndrome at each cycle.

Counselling the patient

Take the tablets with water within about half an hour after food.
Report severe diarrhoea, mouth ulcers or painful redness and peeling of the palms and soles promptly as the dose may need adjusting.
Seek urgent advice if you develop a fever, which may indicate infection.

Evidence & guidelines

The MHRA has issued guidance mandating DPD testing before fluoropyrimidine treatment to reduce the risk of severe toxicity.

Reference: MHRA Drug Safety Update; NICE TAs; ESMO; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways