Capecitabine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Adjuvant therapy in stage III colon cancer; Metastatic colorectal cancer As monotherapy: Initial: 1,250 mg/m2 bid for 14 days followed by 7 days rest period. As combination: Initial: 800-1,000 mg/m2 bid for 14 days followed by 7 days rest period. Alternatively, 625 mg/m2bid given continuously. Treatment duration for adjuvant therapy in stage III colon cancer: 6 months. Metastatic breast cancer; Advanced or locally advanced breast cancer As monotherapy or in combination with docetaxel: Initial: 1,250 mg/m2 bid for 14 days followed by 7 days rest period. Gastric cancer In combination with platinum-based regimen: Initial: 800-1,000 mg/m2 bid for 14 days followed by 7 days rest period. Alternatively, 625 mg/m2 bid given continuously.
Administration
Should be taken with food. Take w/in 30 min after meals.
Contraindications
Known complete absence of dihydropyrimidine dehydrogenase (DPD) activity; severe leucopenia, neutropenia or thrombocytopenia. Severe renal (CrCl <30 mL/min) and hepatic impairment. Pregnancy and lactation. Concomitant use with brivudine and oral coumarin-derivative anticoagulants (e.g. warfarin, phenprocoumon); if concomitant use with coumarin anticoagulants cannot be avoided, closely monitor INR and prothrombin time with great frequency and adjust anticoagulant dose accordingly.
Special Precautions
Patient with severe diarrhoea, dehydration, electrolyte disturbance, history of coronary artery disease, central or peripheral nervous system disease (e.g. neuropathy, brain metastases), hyperbilirubinaemia, diabetes, pre-existing hypo- or hypercalcaemia. Patient with low DPD activity. Mild to moderate renal and hepatic impairment. Patient Counselling This drug may cause dizziness and fatigue, if affected, do not drive or operate machinery. Monitoring Parameters Monitor hepatic, renal, and cardiac functions. Frequent monitoring of INR or prothrombin time in patients taking concomitant oral coumarin-derivative anticoagulant therapy.
Adverse Reactions
Significant: Hand-and-foot syndrome/palmar-plantar erythrodysaesthesia syndrome, bone marrow suppression (e.g. neutropenia, anaemia), hepatotoxicity (e.g. elevated levels of transaminase, alkaline phosphatase and bilirubin), hypo- or hypercalcaemia. Cardiac disorders: Chest pain. Eye disorders: Increased lacrimation, conjunctivitis, eye irritation. Gastrointestinal disorders: Diarrhoea, vomiting, nausea, stomatitis, abdominal pain, gastrointestinal haemorrhage, constipation, dyspepsia, flatulence, dry mouth, decreased appetite. General disorders and administration site conditions: Fatigue, asthenia, pyrexia, peripheral oedema, malaise. Hepatobiliary disorders: Hyperbilirubinaemia, LFT abnormalities. Infections and infestations: Herpes. Metabolism and nutrition disorders: Dehydration, decreased weight. Musculoskeletal and connective tissue disorders: Pain in extremity, back pain, arthralgia. Nervous system disorders: Headache, lethargy, dizziness, paresthesia, dysgeusia. Psychiatric disorders: Insomnia, depression. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, lower respiratory tract infection, dyspnoea, epistaxis, cough, rhinorrhoea. Skin and subcutaneous tissue disorders: Alopecia, rash, erythema, dry skin, pruritus, skin hyperpigmentation, macular rash, skin desquamation, dermatitis, pigmentation disorder, nail disorder. Vascular disorders: Thrombophlebitis.
Potentially Fatal: Stevens-Johnson, toxic epidermal necrolysis, cardiotoxicity (e.g. myocardial infarction, ischemia, angina, dysrhythmias, cardiac arrest, cardiac failure, sudden death, ECG changes, cardiomyopathy), gastrointestinal toxicity (e.g. severe diarrhoea, dehydration).
Drug Interactions
May increase phenytoin plasma concentration and toxicity. Al- and Mg-containing antacids may slightly increase capecitabine concentration. Allopurinol may decrease the concentration of capecitabine. Decreased Max tolerated dose with folinic acid and interferon-α.
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on capecitabine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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