Capecitabine
XELODA
Pronunciation: ka-pe-SITE-a-been (ze-LOE-da)
What it isOral fluoropyrimidine prodrug converted to fluorouracil preferentially in tumor; colorectal, breast, and gastric cancers.
Why this oneOral therapy replaces infusional fluorouracil and the central line that goes with it.
What limits it⚑ DPD deficiency can cause life-threatening toxicity. Hand-foot syndrome limits treatment, and warfarin exposure can rise sharply.
Capecitabine prescription history
Animated chart of estimated U.S. prescriptions per year, Oral anticancer meds (1953–2026). Capecitabine enters in 1998 (estimated).
FDA-approved for
- metastatic colorectal and breast cancer (1998)
Classes and tags
Clinical profile
Legacy pregnancy categoryD
Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Colon cancer, adjuvant — single agent | Adults | 1,250 mg/m² BID | 1,250 mg/m² BID, days 1–14 of 21-day cycle | 8 cycles |
| Colon cancer, adjuvant — with oxaliplatin | Adults | 1,000 mg/m² BID | 1,000 mg/m² BID, days 1–14 of 21-day cycle | 8 cycles |
| Rectal cancer, perioperative — with radiation | Adults | 825 mg/m² BID | 825 mg/m² BID | |
| Rectal cancer, perioperative — without radiation | Adults | 1,250 mg/m² BID | 1,250 mg/m² BID | |
| Metastatic colorectal — single agent | Adults | 1,250 mg/m² BID | 1,250 mg/m² BID, days 1–14 of 21-day cycle | Until progression/toxicity |
| Metastatic colorectal — with oxaliplatin | Adults | 1,000 mg/m² BID | 1,000 mg/m² BID, days 1–14 of 21-day cycle | Until progression/toxicity |
| Metastatic breast — single agent | Adults | 1,000 or 1,250 mg/m² BID | 1,000 or 1,250 mg/m² BID, days 1–14 of 21-day cycle | Until progression/toxicity |
| Metastatic breast — with docetaxel | Adults | 1,000 or 1,250 mg/m² BID | 1,000 or 1,250 mg/m² BID, days 1–14 of 21-day cycle | Until progression/toxicity |
| Gastric/esophageal/GEJ — with platinum chemo | Adults | 625 mg/m² BID | 625 mg/m² BID, days 1–21 of 21-day cycle | 8 cycles |
| Gastric/esophageal/GEJ — with oxaliplatin | Adults | 850 or 1,000 mg/m² BID | 850 or 1,000 mg/m² BID, days 1–14 of 21-day cycle | Until progression/toxicity |
| HER2+ metastatic gastric/GEJ — with cisplatin + trastuzumab | Adults | 1,000 mg/m² BID | 1,000 mg/m² BID, days 1–14 of 21-day cycle | Until progression/toxicity |
| Pancreatic cancer — with gemcitabine | Adults | 830 mg/m² BID | 830 mg/m² BID, days 1–21 of 28-day cycle | 6 cycles |
Renal CrCl 30–50 mL/min: reduce dose 25%; CrCl <30 mL/min: not established
Hepatic Monitor more frequently for adverse reactions; severe impairment not studied
Do not replace a missed dose or a dose lost to vomiting — resume with next scheduled dose
Instructions
- Swallow whole with water within 30 min after a meal; do not chew/cut/crush
- Take ~12 h apart at the same time daily
- Round dose to the nearest 150 mg
- Test for DPYD variants before starting; avoid in complete DPD deficiency
- Hazardous drug — follow special handling/disposal
Available strengths
- tab 150, 500 mg
Contraindications
- Severe hypersensitivity to fluorouracil or capecitabine
Cautions
- Serious/fatal toxicity in DPD deficiency (DPYD variants)
- Cardiotoxicity
- Diarrhea
- Dehydration
- Renal toxicity
- Severe skin reactions (SJS/TEN)
- Palmar-plantar erythrodysesthesia (hand-foot syndrome)
- Myelosuppression
- Hyperbilirubinemia
- Embryo-fetal toxicity
Adverse reactions
- Hand-foot syndrome (PPES)
- Diarrhea
- Nausea/vomiting
- Stomatitis
- Anemia
- Hyperbilirubinemia
- Fatigue
- Abdominal pain
Pregnancy Can cause fetal harm; verify pregnancy status and advise effective contraception
Lactation Do not breastfeed during treatment and for 1 week after last dose
Cost
Generic entry2013
Active metabolites
Open Capecitabine in the interactive console ↗
Self-check
- Which deficiency can make capecitabine life-threatening?
DPD deficiency. - Which anticoagulant exposure can rise sharply with capecitabine?
Warfarin.