Xeltabine Patient Counseling Information

Information for patient: Patients and patients' caregivers should be informed of the expected adverse effects of Capecitabine (Xeltabine), particularly nausea, vomiting, diarrhea, and hand-and-foot syndrome, and should be made aware that patient-specific dose adaptations during therapy are expected and necessary (see Dosage & Administration). Patients should be encouraged to recognize the common grade 2 toxicities associated with Capecitabine (Xeltabine) treatment.
Diarrhea: Patients experiencing grade 2 diarrhea (an increase of 4 to 6 stools/day or nocturnal stools) or greater should be instructed to stop taking Capecitabine (Xeltabine) immediately. Standard antidiarrheal treatments (eg, loperamide) are recommended.
Nausea: Patients experiencing grade 2 nausea (food intake significantly decreased but able to eat intermittently) or greater should be instructed to stop taking Capecitabine (Xeltabine) immediately. Initiation of symtomatic treatment is recommended.
Vomiting: Patients experiencing grade 2 vomiting (2 to 5 episodes in a 24-hour period) or greater should be instructed to stop taking Capecitabine (Xeltabine) immediately. Initiation of symptomatic treatment is recommended.
Hand-and-Foot Syndrome: Patients experiencing grade 2 hand-and-foot syndrome (painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patients' activities of daily living) or greater should be instructed to stop taking Capecitabine (Xeltabine) immediately.
Stomatitis: Patients experiencing grade 2 stomatitis (painful erythema, edema or ulcers of the mouth or tongue, but able to eat) or greater should be instructed to stop taking Capecitabine (Xeltabine) immediately. Initiation of symptomatic treatment is recommended (see Dosage & Administration).
Patients who develop a fever of 38°C or greater or other evidence of potential infection should be instructed to call their physician.
Drug-food interaction: In all clinical trials, patients were instructed to administer Capecitabine (Xeltabine) within 30 minutes after a meal. Since current safety and efficacy data are based upon administration with food, it is recommended that Capecitabine (Xeltabine) be administered with food (see Dosage & Administration).
In studies of fertility and general reproductive performance in male mice, this dose caused degenerative testicle changes in the testes, including decreases in the weight of testicle and epididymis, the number of spermatocytes and spermatids. In females, oral Capecitabine (Xeltabine) doses of 760 mg/kg/day (about 2300 mg/m²/day) disturbed estrus and consequently caused a decrease in fertility. In mice that became pregnant, no fetuses survived this dose.
Capecitabine (Xeltabine) at doses of 198 mg/kg/day during organogenesis caused malformations and embryo death in mice. Malformations in mice included cleft palate, anophthalmia, microphthalmia, polydactyly, syndactyly, kinky tail and dilation of cerebral ventricles. In separate pharmacokinetic studies, this dose in mice produced 5'-DFUR AUC values about 0.2 times the corresponding values in patients administered the recommended daily dose.
At doses of 90 mg/kg/day, Capecitabine (Xeltabine) given to pregnant monkeys during organogenesis caused fetal death. This dose produced 5'-DFUR AUC values about 0.6 times the corresponding values in patients administered the recommended daily dose.
Biological test result shows Capecitabine (Xeltabine) is to decrease the immune functions.
Pre-clinical test result shows significant structural anomaly of chromosome statistically when metabolic activation system doesn't exist in chromosome aberration test using peripheral blood lymphocytes of human.