Capiibine

In combination w/ docetaxel for locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Monotherapy for locally advanced or metastatic breast cancer after failure of taxane & anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. In combination w/ lapatinib ditosylate for advanced or metastatic breast cancer whose tumours overexpress HER2 & who have received prior therapy including anthracycline, taxane & trastuzumab. Metastatic CRC. 1st-line treatment of advanced oesophagogastric cancer in combination w/ platinum-based regimen. Adjuvant treatment of patients following surgery of stage III (Duke's stage C) colon cancer.

Colon, breast & CRC Monotherapy: Initially 1,250 mg/m² bd (morning & evening) for 2 wk followed by 7-day rest period. Combination therapy: Breast cancer In combination w/ docetaxel: 1,250 mg/m² bd for 2 wk followed by 7-day rest period & docetaxel 75 mg/m² as 1-hr IV infusion every 3 wk. In combination w/ lapatinib ditosylate: 2,000 mg/m² daily in 2 doses 12 hr apart for Day 1-14 in repeating 21-day cycle & lapatinib ditosylate 1,250 mg once daily from Day 1-21. Colon, CRC In combination w/ oxaliplatin &/or bevacizumab: 1,000 mg/m² bd for 2 wk followed by 7-day rest period (1st dose given on evening of Day 1 & last dose on morning of Day 15) & bevacizumab 7.5 mg/kg IV infusion over 30-90 min followed by oxaliplatin 130 mg/m² IV infusion over 2 hr given as 3-wkly schedule on Day 1 every 3 wk. Adjuvant treatment w/ stage III colon cancer Duration: 6 mth. Gastric cancer In combination w/ platinum-based regimen: 1,000 mg/m² bd for 14 days followed by 7-day rest period (1st dose given on evening of Day 1 & last dose on morning of Day 15). In combination w/ epirubicin: 625 mg/m² bd continuously & epirubicin 50 mg/m² as IV bolus in day 1 every 3 wk then cisplatin 60 mg/m² (triple regimen), 80 mg/m² (double regimen) or oxaliplatin 130 mg/m² on day 1 as 2-hr IV infusion every 3 wk. Elderly ≥60 yr In combination w/ docetaxel: Initially 950 mg/m² bd. Elderly ≥65 yr In combination w/ irinotecan: Initially 800 mg/m² bd. Moderate renal impairment (CrCl 30-50 mL/min) Initially 1,250 mg/m².

Should be taken with food: Swallow whole w/ water w/in 30 min after meal, do not crush/cut.

Hypersensitivity to capecitabine or fluorouracil. History of severe & unexpected reactions to fluoropyrimidine therapy. Known complete dihydropyrimidine dehydrogenase (DPD) deficiency. Severe leukopenia, neutropenia or thrombocytopenia. Not to be used concomitantly w/ sorivudine or brivudine. Severe renal impairment (CrCl <30 mL/min).

Permanently discontinue use if severe skin reactions occur. Interrupt treatment if grade ≥2 dehydration, grade 2 or 3 hand-foot syndrome; treatment-related bilirubin >3 x ULN or ALT/AST elevations >2.5 x ULN occur. Prior history of CAD, significant cardiac disease, arrhythmias & angina pectoris; preexisting hypo- or hypercalcaemia; central or peripheral nervous system disease eg, brain metastasis or neuropathy; DM or electrolyte disturbances; complete or partial DPD. Monitor patients w/ severe diarrhoea & give fluid & electrolyte replacement upon dehydration. Perform phenotype &/or genotype testing for DPD deficiency prior to therapy. Carefully monitor for ophthalmological complications eg, keratitis & corneal disorders. Not to be administered concomitantly w/ brivudine. Closely monitor INR or prothrombin time w/ concomitant oral coumarin-derivative anticoagulant therapy. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Mild to moderate hepatic dysfunction. Moderate renal impairment. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception during & for 6 mth after last dose. Male partners should use effective contraception during & for 3 mth after last dose. Not to be used during pregnancy, lactation & for 2 wk after last dose. Childn & adolescents <18 yr. Elderly ≥60 yr.

GI disorders eg, diarrhoea, nausea, vomiting, abdominal pain, stomatitis; hand-foot syndrome eg, palmar-plantar erythrodysesthesia; fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction, thrombosis/embolism.

Increased toxicity w/ brivudine. Altered coagulation parameters &/or bleeding w/ coumarin-derivative anticoagulants eg, warfarin & phenprocoumon. Increased phenytoin plasma conc. Enhanced toxicity w/ folinic/folic acid. Increased plasma conc w/ Al- & Mg hydroxide-containing antacids. Decreased absorption rate w/ food intake. Avoid concomitant use w/ allopurinol. Concomitant use w/ CYP2C9 substrates; interferon-α & RT.

Cytotoxic Chemotherapy

L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

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