|
See related Xeloda film-coated tab information |
|
|
|
Manufacturer |
Roche |
|
Distributor |
Hong Kong: DKSH |
|
Contents |
Capecitabine |
|
Indications |
Treatment of patients w/ metastatic colorectal carcinoma. Monotherapy for the treatment of patients w/ locally advanced or metastatic breast cancer after failure of a taxane & an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. In combination w/ docetaxel for the treatment of patients w/ locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. 1st-line treatment of advanced gastric cancer in combination w/ a platinum-based regimen. |
|
Dosage |
Colon, colorectal & breast cancer monotherapy 1,250 mg/m2 bd for 14 days followed by a 7-day rest period. Breast cancer combination therapy w/ docetaxel Initially 1,250 mg/m2 bd for 2 wk followed by a 7-day rest period, combined w/ docetaxel 75 mg/m2 as a 1-hr IV infusion every 3 wk. Colon, colorectal & gastric cancer combination therapy Initially 800-1,000 mg/m2 bd for 2 wk followed by a 7-day rest period or 625 mg/m2 bd continuously. Stage III colon cancer Adjuvant treatment is recommended for a total of 6 mth. |
|
Administration |
Should be taken with food (Take w/in ½ hr after meals.). |
|
Contraindications |
History of severe & unexpected reactions to fluoropyrimidine therapy or hypersensitivity to capecitabine or any of the excipients or fluorouracil. DPD deficiency, severe renal impairment. Do not administer w/ sorivudine or its chemically related analogues (eg brivudine). Pregnancy & lactation. |
|
Special Precautions |
Patients concurrently on coumarin-derivative anticoagulants should be monitored regularly for alterations in their coagulation parameters. May induce hyperbilirubinemia. Hepatic impairment. Severe diarrhoea. Childn <18 yr. Elderly. |
|
Adverse Drug Reactions |
GI disorders, hand-foot syndrome (palmar-plantar erythrodysesthesia or chemotherapy-induced acral erythema); anorexia, dermatitis, fatigue, lethargy; neutropenia, leukopenia, febrile neutropenia, thrombocytopenia, anaemia, decreased appetite, peripheral neuropathy, peripheral sensory neuropathy, neuropathy, taste disturbance, paraesthesia, dysgeusia, dyasthesia, headache, increased lacrimation, thrombosis/embolism, HTN, lower limb eodema, dysaesthesia pharynx, sore throat, alopecia, nail disorder, arthragia, myalgia, pain in extremity, pyrexia, asthenia, weakness, temperature intolerance.
View ADR Monitoring Form |
|
Drug Interactions |
Coumarin anticoagulants, CYP450 2C9 substrates, leucovorin, phenytoin, sorivudine & its analogues eg brivudine, antacids.
View more drug interactions with Xeloda |
|
Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
|
