Active Ingredients: Capecitabine.
Package:
TABLETS: 60 x 150 mg, 120 x 500 mg. Dosage:
Colorectal, adjuvant colon cancer & breast cancer: The recommended dose is 1,250 mg/m2 2 x daily (morning and evening; equivalent to 2,500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period given as 3-week cycles.
Advanced gastric cancer: The recommended dose is 1,000 mg/m2 administered 2 x daily for 14 days followed by a 7-day rest period. Should be swallowed with water within 30 minutes after a meal. See prescribing information for full details. Prescribing Restrictions:
Indications:
Adjuvant colon cancer: For the adjuvant treatment of patients following surgery of stage III (Duke's stage C) colon cancer.
Colorectal cancer: For the treatment of patients with advanced or metastatic colorectal cancer.
Advanced gastric cancer: For first line treatment of advanced gastric cancer in combination with chemotherapy.
Breast cancer combination therapy: In combination with docetaxel for the treatment of paients with metastatic breast cancer after failure of prior anthracyline-containing chemotherapy.
Breast cancer monotherapy: For the treatment of advanced or metastatic breast cancer after failure of standard therapy, including a taxane, unless therapy with a taxane is clinically contraindicated. Contra-Indications:
History of severe and unexpected reactions to fluoropyrimidine therapy. Hypersensitivity to capecitabine or to any of the excipients or fluorouracil. Known dihydropyrimidine dehydrogenase (DPD) deficiency. Pregnancy and lactation. Severe leucopenia, neutropenia or thrombocytopenia. Severe hepatic impairment. Severe renal impairment (creatinine clearance below 30 ml/min). Treatment with sorivudine or its chemically related analogues, such as brivudine. If contraindications exist to any of the other agents in the combination regimen, that agent should not be used. See prescribing information for full details. Special Precautions:
Can induce the occurrence of diarrhea. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. If grade 2, 3 or 4 diarrhea occurs, therapy should be immediately interrupted until the diarrhea resolves or decreases in intensity to grade 1.
See prescribing information for full details.
Hand-foot syndrome (palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema). If grade 2 or 3 hand- foot syndrome occurs, administration should be interrupted until the event resolves or decreases in intensity to grade 1. Following grade 3 hand-foot syndrome, subsequent doses should be decreased.
See prescribing information for full details.
Cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiographic changes. These adverse reactions may be more common in patients with a prior history of coronary artery disease.
See prescribing information for full details.
Hypo- or hypercalcaemia has been reported during treatment.
Central or peripheral nervous system disease. Caution must be exercised in patients with central or peripheral nervous system disease, e.g. brain metastasis or neuropathy.
Diabetes mellitus or electrolyte disturbances. Caution must be exercised in patients with diabetes mellitus or electrolyte disturbances, as these may be aggravated during treatment.
Concomitant treatment with coumarin-derivative anticoagulation: See prescribing information for full details.
Hepatic impairment: Treatment should be carefully monitored in patients with mild to moderate liver dysfunction, regardless of the presence or absence of liver metastasis.
Renal impairment. See prescribing information for full details.
Contains anhydrous lactose as an excipient. See prescribing information for full details. Side Effects:
Gastrointestinal disorders, especially diarrhea, nausea, vomiting, abdominal pain, stomatitis), fatigue and hand-foot syndrome (palmar-plantar erythrodysesthesia).
In combination with oxaliplatin: Anemia, leukopenia, neutropenia, thrombocytopenia, neuropathy,bleeding.
In combination with epirubicin, oxaliplatin, epirubicin or cisplatin: Leukopenia, neutropenia, lethargy, anemia, thrombocytopenia, febrile neutropenia, peripheral neuropathy, infection, fever, thromboembolism. See prescribing information for full details. Drug Interactions:
Coumarin-derivative anticoagulants; phenytoin; sorivudine or its chemically related analogs, such as brivudine; allopurinol. See prescribing information for full details.
