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 - Responses were defined by the World Health Organization criteria and submitted to a blinded independent review committee (IRC). The hazard ratio for DFS for Capecitabine compared to 5-FU/LV was 0.88 (95% C.I.

Secondly, data on lifestyle measures and nutritional intake were not available in CAIRO3, and both may have impact on SMI loss and toxicity risk. Capecitabine tablets may affect the way other medicines work, and other medicines may affect the way Capecitabine tablets works.Know the medicines you take. Mean BMI was lower in sarcopenic patients, although patients were on average still overweight (sarcopenic vs. non‐sarcopenic at the start of CAP‐B 25.0 ± 3.9 vs. 26.7 ± 4.1 and CAPOX‐B 25.8 ± 3.8 vs. 27.1 ± 3.8 kg/mIn this large longitudinal study in metastatic colorectal cancer patients during palliative systemic treatment, sarcopenia and/or muscle loss was associated with an increased risk of DLTs. In separate pharmacokinetic studies, this dose in mice produced 5’-DFUR AUC values that were approximately 0.2 times the AUC values in patients administered the recommended daily dose. Advise patients if they have complete or near complete absence of DPD activity they are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions causedby Capecitabine tablets (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity) Instruct patients experiencing grade 2 or higher dehydration (IV fluids indicated < 24 hours) to stop taking Capecitabine tablets immediately and to call their healthcare provider to correct the dehydration. Do not use Capecitabine tablets for a condition for which it was not prescribed. There was no apparent advantage in response rate to adding leucovorin to Capecitabine; however, toxicity was increased. Prospective studies should reveal whether normalizing chemotherapeutic doses to muscle mass or preservation of muscle mass (by exercise and nutritional interventions) increases chemotherapeutic tolerance and improves survival.We thank all patients and staff at each of the study centres.

BMI was not associated with DLTs and could not accurately detect sarcopenia or SMI loss. Capecitabine Warfarin Interaction: Patients receiving concomitant Capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. Patients with anorexia, asthenia, nausea, vomiting or diarrhea may rapidly become dehydrated. BSA was calculated using the Mosteller formula: Dose‐limiting toxicities were defined as any dose delay (>3 days), reduction, or discontinuation of systemic treatment because of reported toxicities. when excluded patients with poor prognosis had an increased risk of DLTs). Cytidine deaminase, an enzyme found in most tissues, including tumors, subsequently converts 5’DFCR to 5’-DFUR. Firstly, patients were excluded if CT scans were unavailable, for example, because of treatment discontinuation or disease progression. The enzyme, thymidine phosphorylase (dThdPase), then hydrolyzes 5’-DFUR to the active drug 5-FU. There is insufficient data to recommend a specific dose in patients with partial DPD activity as measured by any specific test.Dehydration has been observed and may cause acute renal failure which can be fatal.