Concise Prescribing Info
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 a taxane, & an anthracycline-containing regimen or for whom further anthracycyline therapy is not indicated. Metastatic colorectal carcinoma; as adjuvant treatment following surgery of stage III (Duke's stage C) colon cancer. 1st-line treatment of advanced gastric cancer in combination w/ platinum-based regimen.
Dosage/Direction for Use
Monotherapy: Colon, colorectal & breast cancer 1,250 mg/m2 bd for 2 wk followed by a 7-day rest period. Duration of treatment: 6 mth (for adjuvant treatment of stage III colon cancer). Combination therapy: Breast cancer Initially 1,250 mg/m2 bd for 2 wk followed by a 7-day rest period combined w/ docetaxel at 75 mg/m2 as a 1-hr IV infusion every 3 wk. Colon, colorectal & gastric cancer Starting dose: Reduce to 1,000 mg/m2 bd for 2 wk followed by a 7-day rest period. Duration of treatment: 6 mth (for adjuvant treatment of stage III colon cancer).
Should be taken with food: Take w/in 30 min after meals.
Hypersensitivity. History of severe & unexpected reactions to fluoropyrimidine therapy or known hypersensitivity to fluorouracil. Concomitant use w/ sorivudine or chemically-related analogues eg, brivudine. Severe leukopenia, neutropenia or thrombocytopenia. Severe hepatic & renal impairment (CrCl <30 mL/min).
Special Precautions
Discontinue if progressive disease or intolerable toxicity occurs. Monitor patients w/ severe diarrhea & ensure to give fluid & electrolyte replacement. Correct or prevent dehydration at the onset of therapy. Interrupt therapy if grade 2 (or higher) dehydration & elevation in bilirubin of >3 x ULN or hepatic aminotransferases (ALT, AST) of >2.5 x ULN occur. Dihydropyrimidine dehydrogenase (DPD) deficiency. Patients w/ history of 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. Permanently discontinue if Stevens-Johnson syndrome & toxic epidermal necrolysis occur. Hand-foot syndrome (≥grade 2 can eventually lead to loss of fingerprints). Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Closely monitor anticoagulant response (INR or prothrombin time) in patients receiving oral coumarin-derivative anticoagulant therapy. Renal or hepatic impairment. Dizziness, fatigue & nausea may affect ability to drive or operate machinery. Women of childbearing potential should avoid becoming pregnant while receiving treatment. Pregnancy & Lactation. Childn <18 yr. Elderly.
Adverse Reactions
Anorexia; diarrhoea, vomiting, nausea, stomatitis, abdominal pain; palmar-plantar erythrodysesthesia syndrome, dermatitis; fatigue, asthenia. Neutropenia, leukopenia, anemia, neutropenic fever, thrombocytopenia; decreased appetite; para- & dysaesthesia, peripheral neuropathy, peripheral sensory neuropathy, dysgeusia, headache; increased lacrimation; lower limb oedema, HTN, thrombosis/embolism; sore throat, pharynx dysaesthesia; constipation, dyspepsia; alopecia, nail disorder; arthralgia, myalgia, pain in extremity; pyrexia, weakness, lethargy, temp intolerance.
Drug Interactions
Altered coagulation parameter &/or bleeding w/ coumarin-derivative anticogulants eg, warfarin & phenprocoumon. Co-administration w/ CYP450 2C9 substrates. Increased phenytoin plasma conc. Decreased rate of absorption w/ food. Increased plasma conc w/ Al & Mg hydroxide-containing antacid. Potentially fatal increased fluoropyrimidine toxicity by sorivudine & analogues (eg, brivudine). Avoid concomitant use w/ allopurinol due to possible decreased 5-FU efficacy.
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Xeloda FC tab 150 mg
Xeloda FC tab 500 mg
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