• Adjuvant treatment of Stage III colon cancer (as monotherapy or in combination with other chemotherapy agents).
• Perioperative treatment of locally advanced rectal cancer (as component of chemoradiotherapy).
• Unresectable or metastatic colorectal cancer (as monotherapy or in combination with other chemotherapy agents).
• Advanced or metastatic breast cancer when an anthracycline- or taxane-containing chemotherapy is not indicated (as monotherapy).
• Advanced or metastatic breast cancer that has progressed despite prior therapy with an anthracycline-based chemotherapy regimen (in combination with docetaxel).
• Unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer (in combination with other chemotherapy agents).
• HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease (in combination with other agents).
• Adjuvant treatment of pancreatic adenocarcinoma (in combination with other chemotherapy agents).

Contraindicated in:

• Hypersensitivity to capecitabine or 5-fluorouracil
• Severe renal impairment (CCr <30 mL/min)
• Complete dihydropyrimidine dehydrogenase deficiency (↑ risk of 5-fluorouracil toxicity)
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Partial dihydropyrimidine dehydrogenase deficiency
• Mild to moderate renal impairment (↓ initial dose for CCr 30–50 mL/min)
• Hepatic impairment
• Coronary artery disease
• Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety not established in children
• Geri: ↑risk of severe diarrhea in patients 80 yr.

CV: edema, arrhythmias, chest pain, HF, MYOCARDIAL ISCHEMIA/INFARCTION, SUDDEN CARDIAC DEATH.

Derm: dermatitis, hand-and-foot syndrome, nail disorder, alopecia, erythema, rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

EENT: eye irritation, epistaxis, rhinorrhea.

F and E: dehydration.

GI: abdominal pain, anorexia, constipation, diarrhea, hyperbilirubinemia, ↑liver enzymes, nausea, stomatitis, vomiting, dyspepsia, NECROTIZING ENTEROCOLITIS, xerostomia.

GU: acute renal failure, ↓ fertility.

Hemat: anemia, neutropenia, thrombocytopenia.

MS: arthralgia, myalgia.

Neuro: dysgeusia, fatigue, headache, dizziness, insomnia, peripheral neuropathy.

Resp: cough, dyspnea.
Misc: fever.

Drug-Drug:

• May ↑ risk of bleeding with warfarin; monitor INR frequently.
• Toxicity ↑ by concurrent leucovorin.
• Antacids may ↑ absorption.
• May ↑ levels and risk of toxicity from phenytoin (may need to ↓ phenytoin dose).
• ↑incidence of acute renal failure with other nephrotoxic drugs.
• Allopurinol may ↓ levels of capecitabine's active metabolite and its overall effectiveness; avoid concurrent use

Drug-Food:

• Food ↑ absorption, although capecitabine should be given within 30 min after a meal.

(Generic available)

• Tablets: 150 mg; 500 mg;

Colorectal Cancer

• PO (Adults): Monotherapy: 1250 mg/m² twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles. In combination with oxaliplatin: 1000 mg/m² twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.

Advanced or Metastatic Breast Cancer

• PO (Adults): Monotherapy or in combination with docetaxel: 1000 mg/m² or 1250 mg/m² twice daily for the first 14 days of each 21-day cycle; continue until disease progression or unacceptable toxicity.

Gastric, Esophageal, or Gastroesophageal Junction Cancer

• PO (Adults): 625 mg/m² twice daily on Days 1–21 of each 21-day cycle for a maximum of 8 cycles (in combination with platinum-containing chemotherapy) OR 850 mg/m² or 1000 mg/m² twice daily for the first 14 days of each 21-day cycle (in combination with oxaliplatin); continue until disease progression or unacceptable toxicity.

Pancreatic Cancer

• PO (Adults): In combination with gemcitabine: 830 mg/m² twice daily for the first 21 days of each 28-day cycle; continue until disease progression, unacceptable toxicity, or a maximum of 6 cycles.

Xeloda

• Converted in tissue to 5-fluorouracil, which inhibits DNA and RNA synthesis by preventing thymidine production.
• The enzyme responsible for the final step in the conversion to 5-fluorouracil may be found in higher concentrations in some tumors.

• Decreased spread of colorectal, breast, gastric, esophageal, gastroesophageal junction, and pancreatic cancer.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites

Absorption: Well absorbed after oral administration.

Distribution: Unknown.

Metabolism/Excretion: Metabolized mostly in tissue and by the liver to 5-fluorouracil; 5-fluorouracil is metabolized by dihydropyrimidine dehydrogenase to a less toxic compound; inactive metabolites are excreted primarily in urine.

Half-life: 45 min.

(plasma concentrations)

†Onset of antineoplastic effect is 6 wk.

†Peak 5-fluorouracil concentrations occur at 2 hr.

• Instruct patient to take medication every 12 hr with water within 30 min after a meal. Missed doses should be omitted; continue regular schedule. If vomiting occurs, omit dose. Do not double dose. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
• Inform patient of the most common side effects. Instruct patient to notify health care provider immediately if any of the following occur: diarrhea (>4 bowel movements in a day or any diarrhea at night), vomiting (more than once in 24 hr), nausea (loss of appetite and significant decrease in daily food intake), stomatitis (pain, redness, swelling, or sore in mouth), hand-and-foot syndrome (pain, swelling, or redness of hands and/or feet), skin reactions (rash, blisters, peeling of skin), fever, or infection (temperature of 100.5° F or other signs of infection).
• Instruct patient to notify health care professional if fever; chills; sore throat; signs of infection; yellowing of skin or eyes; abdominal pain; joint or flank pain; swelling of feet or legs; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patients should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
  • Advise patient to rinse mouth with clear water after eating and drinking and to avoid flossing to minimize stomatitis. Viscous lidocaine may be used if mouth pain interferes with eating. Stomatitis pain may require treatment with opioid analgesics.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise females of reproductive potential to use effective contraception during and for at least 6 mo after last dose. Advise males with female partners of reproductive potential to use effective contraception for at least 3 mo after last dose. Avoid breastfeeding during and for 1 wk after last dose. May impair fertility of female and male patients of reproductive potential.
  • Emphasize the importance of routine follow-up lab tests to monitor progress and to check for side effects.

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