Oral administration of capecitabine to pregnant monkeys during the period of organogenesis at a dose of 90 mg/kg/day, caused fetal lethality. Advise males with female partners of … Use Older adults may be more sensitive to the side effects of this medication, especially If someone has overdosed and has serious symptoms such as passing out or If you miss a dose, skip the missed dose. 0.77 – 1.01) (see Advise females not to breastfeed during treatment with capecitabine and for 2 weeks after the last dose Capecitabine was administered at a dose of 1255 mg/m Published literature reported that concomitant use with allopurinol may decrease conversion of capecitabine to the active metabolites, FdUMP and FUTP; however, the clinical significance was not fully characterized.A Phase 1 study evaluated the effect of capecitabine on the pharmacokinetics of docetaxel (Taxotere You may report side effects to Health Canada at 1-866-234-2345.Capecitabine can make you more likely to get infections or may worsen any current infections. The primary objective of the study was to compare disease-free survival (DFS) in patients receiving capecitabine to those receiving IV 5-FU/LV alone. People 80 years of age or older may be more likely to develop severe or serious side effects with capecitabine tablets.Capecitabine tablets may cause fertility problems in females and males. Food reduced both the rate and extent of absorption of capecitabine. Grade 3 hand-and-foot syndrome is defined as moist desquamation, ulceration, blistering or severe pain of the hands and/or feet and/or severe discomfort that causes the patient to be unable to work or perform activities of daily living. [see Warnings and Precautions (5.2) and Drug Interactions (7.1)]Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)Table 1 Capecitabine Tablets Dose Calculation According to Body Surface AreaNumber of Tablets to be Taken at Each Dose (Morning and Evening) In Combination With Docetaxel (Metastatic Breast Cancer) Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer) Table 2 Recommended Dose Modifications of Capecitabine TabletsIn Combination With Docetaxel (Metastatic Breast Cancer) Table 3 Docetaxel Dose Reduction Schedule in Combination with Capecitabine Tablets2.4 Adjustment of Starting Dose in Special Populations [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)][see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]see Dosage and Administration (2.3), Use in Specific Populations (8.7), and Clinica[see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]Table 4 Percent Incidence of Adverse Reactions Reported in ≥5% of Patients Treated With Capecitabine or 5-FU/LV for Colon Cancer in the Adjuvant Setting (Safety Population)General Disorders and Administration Site Conditions Percent Incidence of Grade 3/4 Laboratory Abnormalities Reported in ≥1% of Patients Receiving Capecitabine Monotherapy for Adjuvant Treatment of Colon Cancer (Safety Population)Table 6 Pooled Phase 3 Colorectal Trials: Percent Incidence of Adverse Reactions in ≥5% of PatientsTable 7 Percent Incidence of Adverse Events Considered Related or Unrelated to Treatment in ≥5% of Patients Participating in the Capecitabine and Docetaxel Combination vs Docetaxel Monotherapy StudyNumber of Patients With at Least One Adverse Event Table 8 Percent of Patients With Laboratory Abnormalities Participating in the Capecitabine and Docetaxel Combination vs Docetaxel Monotherapy StudyTable 9 Percent Incidence of Adverse Reactions Considered Remotely, Possibly or Probably Related to Treatment in ≥5% of Patients Participating in the Single Arm Trial in Stage IV Breast Cancer6.4 Clinically Relevant Adverse Events in <5% of PatientsMonotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer) Capecitabine In Combination With Docetaxel (Metastatic Breast Cancer)[see Warnings and Precautions (5.11) and Clinical Pharmacology (12.3)].
Delay treatment until resolved to grade 0-1; Resume treatment at 55 mg/m Altered coagulation parameters and/or bleeding, including death, have been reported during concomitant use. The level of phenytoin should be carefully monitored in patients taking capecitabine and phenytoin dose may need to be reduced Malformations in mice included cleft palate, anophthalmia, microphthalmia, oligodactyly, polydactyly, syndactyly, kinky tail and dilation of cerebral ventricles. A total of 995 patients were treated with 1250 mg/m
The dose reduction schedule for docetaxel when used in combination with capecitabine tablets for the treatment of metastatic breast cancer is shown in Increased level of bilirubin in your blood and liver problems. Capecitabine INTERACTIONS: AGENT EFFECT MECHANISM MANAGEMENT docetaxel2 no pharmacokinetic interactions . In 875 patients with either metastatic breast or colorectal cancer who received a dose of 1250 mg/m
KEEP TIGHTLY CLOSED.Capecitabine is a cytotoxic drug. Do not double the dose to catch up.Store in a tightly closed container at room temperature away from light and moisture. Although no clinical experience using dialysis as a treatment for capecitabine overdose has been reported, dialysis may be of benefit in reducing circulating concentrations of 5’-DFUR, a low–molecular-weight metabolite of the parent compound.Single doses of capecitabine were not lethal to mice, rats, and monkeys at doses up to 2000 mg/kg (2.4, 4.8, and 9.6 times the recommended human daily dose on a mg/m *The incidence of grade 3/4 white blood cell abnormalities was 1.3% in the capecitabine arm and 4.9% in the IV 5-FU/LV arm.
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