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Pharmacologic class: Fluoropyrimidine, antimetabolite (pyrimidine analog)

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Box Warning

• In patients receiving concomitant oral coumarin-derivative anticoagulants (such as warfarin and phenprocoumon), monitor International Normalized Ratio (INR) or prothrombin time (PT) frequently to allow appropriate anticoagulant dosage adjustment. Altered coagulation parameters, bleeding, and death have occurred in patients taking this drug combination. Postmarketing reports show significant INR and PT increases in patients stabilized on anticoagulants when capecitabine therapy began. Age older than 60 and cancer diagnosis independently increase coagulopathy risk.


Enzymatically converts to 5-fluorouracil, which injures cells by interfering with DNA synthesis, cell division, RNA processing, and protein synthesis


Tablets: 150 mg, 500 mg

Indications and dosages

Metastatic breast cancer resistant to both paclitaxel and a chemotherapy regimen that includes anthracycline; metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred

Adults: Initially, 2,500 mg/m2/day P.O. in two divided doses for 2 weeks, followed by a 1-week rest period; administered in 3-week cycles

Dosage adjustment

• Renal impairment

• Hepatic impairment

• Elderly patients


• Hypersensitivity to drug

• Severe renal impairment

• Pregnancy or breastfeeding


Use cautiously in:

• mild to moderate renal impairment, hepatic impairment, severe diarrhea, coronary artery disease, intestinal disease, infection, coagulopathy

• children younger than age 18.


• Give with water within 30 minutes after a meal.

• If dosage must be lowered because of toxicity, don't increase dosage later.

Adverse reactions

CNS: dizziness, fatigue, headache, insomnia, paresthesia

CV: edema

EENT: eye irritation

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, anorexia, stomatitis, intestinal obstruction

Hematologic: anemia, lymphopenia, neutropenia, thrombocytopenia

Metabolic: dehydration

Musculoskeletal: myalgia, limb pain

Skin: dermatitis, alopecia, nail disorder, hand and foot syndrome (palmarplantar erythrodysesthesia)

Other: fever


Drug-drug. Antacids: increased capecitabine blood level

Leucovorin: increased cytotoxicity

Live-virus vaccines: impaired ability to mount an immune response to vaccine

Phenytoin: increased phenytoin blood level

Warfarin: increased risk of bleeding

Drug-diagnostic tests. Bilirubin: increased level

Hemoglobin, neutrophils, platelets, white blood cells: decreased levels

Patient monitoring

• Monitor patient for signs and symptoms of toxicity. Be prepared to reduce dosage or withhold drug when indicated.

• Stay alert for signs and symptoms of infection.

• Carefully assess fluid and electrolyte status if patient has severe diarrhea.

• Monitor weight, CBC, International Normalized Ratio, prothrombin time, and kidney and liver function test results.

• Evaluate closely for adverse reactions in patients older than age 80.

Patient teaching

• Advise patient to take drug with water within 30 minutes after a meal.

Instruct patient to immediately report nausea, vomiting, diarrhea, mouth ulcers, swollen joints, temperature above 100.5 °F (38 °C), and other signs or symptoms of infection.

• Tell patient to expect dosage adjustments during therapy.

• Urge patient to use reliable birth control method because drug may harm fetus if she becomes pregnant.

• Caution patient not to breastfeed during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


A trademark for the drug capecitabine.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.


A prodrug of the chemotherapeutic 5-fluorouracil (5-FU), which is used to treat metastatic breast and colorectal cancers. 5-FU inhibits DNA synthesis and slows tumour proliferation.

Adverse effects
EKG changes, acute myocardial infarction, angina, hand-foot syndrome, pain, paraesthesia, erythema, palmoplantar blistering, diarrhoea, nausea, stomatitis, pancytopaenia, hyperbilirubinaemia.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.


Capecitabine Oncology An anticancer agent used for therapy-resistant metastatic breast CA, which targets and is activated by tumor cell enzymes; once activated, the drug is converted to 5-FU. See Breast cancer, 5-FU.
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.
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(33) In 2005, the FDA approved capecitabine (Xeloda, Roche), an oral 5-FU prodrug, for use in metastatic colon cancer.
X-ray irradiation induces thymidine phosphorylase and enhances the efficacy of capecitabine (Xeloda) in human cancer xenografts.
Nine patients received postoperative adjuvant chemotherapy consisting of FOLFOX (oxaliplatin, 5-fluorouracil [5-FU] plus leucovorin) (8/9) or XELOX (oxaliplatin plus Xeloda) (1/9).
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Its key products in India include breast cancer drug Herclon and Xeloda, used to treat patients with colorectal, breast, or colon cancer.Novartis plans to introduce four new products and two line extensions in the areas of congestive heart failure, oncology, pain management and respiratory diseases.
Tykerb was approved by the FDA in 2007, and by the European Medicines Agency (EMA) in 2008, for use in locally-advanced or metastatic breast cancer, in combination with Xeloda (capecitabine).
Mylan, a United States-based pharmaceutical company, has introduced Capecitabine Tablets USP, 150mg and 500mg, the generic version of Genentech's Xeloda Tablets, it was reported yesterday.
Capecitabine (Xeloda) is approved by the Food and Drug Administration for the treatment of breast and colorectal cancers.
Randomised, phase II trial comparing oral capecitabine (Xeloda) with paclitaxel in patients with metastatic/advanced breast cancer pretreated with anthracyclines.
The more recently approved lapatinib is used in combination with another cancer drug called capectabine (Xeloda).