Capecitabine
XELODA
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.
FDA-approved for
- metastatic colorectal and breast cancer (1998)
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
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
⚠ BOXED WARNING
- Warfarin interaction with severe bleeding and death
Cost, est. cash$50–$10,000/month or cycle
Generic entry2013
Classes and tags
Clinical profile
Legacy pregnancy categoryD
Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.
Active metabolites
Mechanism of action: Capecitabine ballicule
