Dose modifications should be applied for the precipitating adverse event as necessary [ Patients with moderate renal impairment at baseline require dose reduction [ Based on findings from animal reproduction studies and its mechanism of action, Capecitabine tablets may cause fetal harm when given to a pregnant woman Severe mucocutaneous reactions, some with fatal outcome, such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (TEN) can occur in patients treated with Capecitabine [ Hand-and-foot syndrome (palmar-plantar erythrodysesthesia or chemotherapy-induced acral erythema) is a cutaneous toxicity. of Prior Chemotherapy Regimens for Treatment of Metastatic DiseaseTable 17 Efficacy of Capecitabine and Docetaxel Combination vs Docetaxel MonotherapyFigure 4 Kaplan-Meier Estimates for Time to Disease Progression Capecitabine and Docetaxel vs DocetaxelFigure 5 Kaplan-Meier Estimates of Survival Capecitabine and Docetaxel vs DocetaxelTable 18 Baseline Demographics and Clinical Characteristics Single-Arm Breast Cancer TrialTable 19 Response Rates in Doubly-Resistant Patients Single-Arm Breast Cancer Trial[see Warnings and Precautions (5.6), Use in Specific Populations (8.1 and 8.3)].What is the most important information I should know aboutCapecitabine tablets can cause serious side effects, including:Capecitabine tablets, tell your healthcare provider about all your medical conditions, including if you:What is the most important information I should know about“What is the most important information I should know aboutof too much body fluid (dehydration) and kidney failure.Increased level of bilirubin in your blood and liver problems.white blood cells, platelets, and red blood cell counts.General information about the safe and effective use ofWe comply with the HONcode standard for trustworthy health information - Adjuvant treatment in patients with Dukes’ C colon cancer is recommended for a total of 6 months [ie, Capecitabine tablets 1250 mg/m *Total Daily Dose divided by 2 to allow equal morning and evening dosesIn combination with docetaxel, the recommended dose of Capecitabine tablets are 1250 mg/m Capecitabine tablets dosage may need to be individualized to optimize patient management. Capecitabine was administered at a dose of 1255 mg/m Antitumor responses for patients with disease resistant to both paclitaxel and an anthracycline are shown in For the subgroup of 43 patients who were doubly resistant, the median time to progression was 102 days and the median survival was 255 days. Study 1 was conducted in the US, Canada, Mexico, and Brazil; Study 2 was conducted in Europe, Israel, Australia, New Zealand, and Taiwan.
Special populations: Patients over 65 (particularly over 80) may be more sensitive to the adverse effects of fluorouracil, especially severe GI toxicity (e.g., diarrhea, nausea, vomiting). Capecitabine tablets may affect the way other medicines work, and other medicines may affect the way capecitabine tablet works.Know the medicines you take. Capecitabine was primarily bound to human albumin (approximately 35%).
“What are the possible side effects of capecitabine tablets?” Before taking capecitabine tablets, tell your healthcare provider about all your medical conditions, including if you: “What is the most important information I should know about capecitabine tablets?”What are the possible side effects of capecitabine tablets?“What is the most important information I should know about capecitabine tablets?”.Loss of too much body fluid (dehydration) and kidney failure. Fecal excretion is minimal (2.6%). Effect of Allopurinol on Capecitabine . Currently, screening for DPD deficiency is not readily available. You may report side effects to FDA at 1-800-FDA-1088.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. for Hazard RatioCapecitabine has been evaluated in clinical trials in combination with docetaxel (Taxotere The dose of Capecitabine used in the phase 3 clinical trial in combination with docetaxel was based on the results of a phase 1 study, where a range of doses of docetaxel administered in 3-week cycles in combination with an intermittent regimen of Capecitabine (14 days of treatment, followed by a 7-day rest period) were evaluated. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
Patients should be carefully monitored for toxicity and doses of Capecitabine tablets should be modified as necessary to accommodate individual patient tolerance to treatment The dose of phenytoin and the dose of coumarin-derivative anticoagulants may need to be reduced when either drug is administered concomitantly with Capecitabine tablets Capecitabine tablets dose modification scheme as described below (see If physician deems it to be in the patient’s best interest to continue, interrupt until resolved to grade 0-1*National Cancer Institute of Canada Common Toxicity Criteria were used except for the hand-and-foot syndrome Dose modifications of Capecitabine tablets for toxicity should be made according to The dose reduction schedule for docetaxel when used in combination with Capecitabine tablets for the treatment of metastatic breast cancer is shown in Delay treatment until resolved to grade 0-1; Resume treatment with original dose of 75 mg/m Delay treatment until resolved to grade 0-1; Resume treatment at 55 mg/m Delay treatment until resolved to grade 0-1; Resume treatment at 55 mg/m *National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome No adjustment to the starting dose of Capecitabine tablets is recommended in patients with mild renal impairment (creatinine clearance = 51 to 80 mL/min [Cockroft and Gault, as shown below]).
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