Korea United Pharma


Concise Prescribing Info
Metastatic colorectal cancer & breast cancer. Adjuvant treatment of patients after surgery for Dukes C colon cancer.
Dosage/Direction for Use
Colon, colorectal & breast cancer 1,250 mg/m2 bid (morning & evening) for 2 wk followed by a 1-wk rest period given as 3-wk cycles. In combination w/ docetaxel: 1,250 mg/m2 bid for 2 wk followed by a 1-wk rest period + docetaxel 75 mg/m2 as 1-hr IV infusion every 3 wk. Adjuvant treatment in patient w/ Dukes' C colon cancer 1,250 mg/m2 bid for 2 wk followed by a 1-wk rest period given as 3-wk cycles. Total: 8 cycles (24 wk). In combination w/ oxaliplatin: 1,000 mg/m2 bid for 2 wk followed by a 1-wk rest period + oxaliplatin 130 mg/m2 IV infusion over 2-hr on day 1 every 3 wk, as 3-wk cycles for 24 wk. Advanced or colon gastric cancer 1,250 mg/m2 bid (morning & evening) for 2 wk followed by 1-wk rest period given as 3-wk cycles. Advanced gastric cancer in combination w/ platinum-based regimen 1st-line treatment: Initially 1,000 mg/m2 bid for 14 days followed by a 7-day rest period or 625 mg/m2 bid. In combination w/ cisplatin: 1,000 mg/m2 bid for 2 wk followed by a 1-wk rest period + cisplatin 80 mg/m2 as 2-hr IV infusion every 3 wk. In combination w/ cisplatin or epirubicin: 625 mg/m2 bid for 3 wk + cisplatin 60 mg/m2 as a 2-hr IV & epirubicin 50 mg/m2 as IV bolus infusion every 3 wk. Patient w/ moderate renal impairment (CrCl 30-50 mL/min at baseline) Reduce dose to 75% for a starting dose of 1,250 mg/m2. Elderly ≥60 yr Starting dose reduction to 75% (950 mg/m2 bid).
Should be taken with food: Take w/in 30 min after a meal.
Hypersensitivity. History of severe & unexpected reactions to fluoropyrimidine therapy. Patients w/ severe renal impairment (CrCl <30 mL/min); known dihydropyrimidine dehydrogenase (DPD) deficiency [unexpected, severe toxicity (eg, stomatitis, diarrhea, neutropenia & neurotoxicity) associated w/ fluorouracil can be occurred]; severe leucopenia, neutropenia or thrombocytopenia; severe hepatic impairment; galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use of sorivudine or its chemically related analogues eg, brivudine; tegafur, gimeracil, oteracil K complex. Pregnancy & lactation.
Special Precautions
Severe diarrhea; dehydration; hand-foot syndrome; cardiotoxicity eg, MI, heart failure, arrhythmias, angina pectoris & cardiomyopathy; pre-existing hypo- or hypercalcemia; CNS/peripheral nervous system disease eg, brain metastasis or neuropathy; DM or electrolyte disturbances; mild to moderate liver dysfunction; moderate & severe renal impairment; myelosuppression; GIT ulcer or bleeding. Concomitant use of coumarin-derivative. May impair ability to drive or operate machinery. Childn <18 yr. Elderly ≥65 yr.
Adverse Reactions
Anorexia; diarrhea, vomiting, nausea, stomatitis, abdominal pain; palmar-plantar erythrodysaesthesia syndrome, fatigue, asthenia. Herpes viral infection, nasopharyngitis, lower resp tract infection; neutropenia, anemia; dehydration, decreased appetite, decreased wt; insomnia, depression; headache, lethargy, dizziness, paresthesia, dysgeusia; increased lacrimation, conjunctivitis, eye irritation; thrombophlebitis; dyspnoea, epistaxis, cough, rhinorrhea; GI hemorrhage, constipation, upper abdominal pain, dyspepsia, flatulence, dry mouth; hyperbilirubinemia, abnormal liver function test; rash, alopecia, erythema, dry skin, pruritus, skin hyperpigmentation & desquamation, rash macular, dermatitis, pigmentation & nail disorder; pain in extremity, back pain, arthralgia; pyrexia, lethargy, peripheral edema, malaise, chest pain.
Drug Interactions
May alter the coagulation parameters (PT or INR) &/or bleeding w/ coumarin-derivative anticoagulants eg, warfarin & phenprocoumon. May slightly increase the plasma conc w/ Al & Mg hydroxide-containing antacid. May impair the effects w/ allopurinol. May increase the fluoropyrimidine toxicity w/ sorivudine or its chemically related analogues eg, brivudine. May increase plasma conc of phenytoin. May enhance the toxicity by folinic acid. May remarkably increase plasma conc w/ tegafur, gimeracil, oteracil K complex.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Xeltabine FC tab 500 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in