capecitabine

capecitabine /cap·e·ci·ta·bine/ (kap?e-si´tah-ben) an antineoplastic used in the treatment of metastatic breast or colorectal carcinoma.

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capecitabine Warning - Hazardous drug!

Xeloda

Pharmacologic class: Fluoropyrimidine, antimetabolite (pyrimidine analog)

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Boxed 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.

Action

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

Availability

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

Contraindications

• Hypersensitivity to drug
• Severe renal impairment
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• mild to moderate renal impairment, hepatic impairment, severe diarrhea, coronary artery disease, intestinal disease, infection, coagulopathy
• children younger than age 18.

Administration

• Give with water within 30 minutes after a meal.
• If dosage must be lowered because of toxicity, don't increase dosage later.

Route	Onset	Peak	Duration
P.O.	Unknown	1.5-2 hr	Unknown

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 (palmar-plantar erythrodysesthesia)

Other: fever

Interactions

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.