Sancitabin Special Precautions

Cardiotoxicity: cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiographic changes. These adverse reactions may be more common in patients with a prior history of coronary artery disease. Cardiac arrhythmias, angina pectoris, myocardial infarction, heart failure and cardiomyopathy have been reported in patients receiving Capecitabine. Caution must be exercised in patients with history of significant cardiac disease, arrhythmias and angina pectoris.
Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (TEN). Capecitabine should be permanently discontinued in patients who experience a severe skin reaction possibly attributable to Capecitabine treatment.
Capecitabine can induce hand-foot syndrome (also known as hand-foot skin reaction palmar-plantar erythrodysesthesia or chemotherapy-induced acral erythema), which is a cutaneous toxicity. Persistent or severe hand-foot syndrome (grade 2 and above) can eventually lead to loss of fingerprints, which could impact patient identification. If grade 2 or 3 hand-foot syndrome occurs, administration of Capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1. Following grade 3 hand-foot syndrome, subsequent doses of Capecitabine should be decreased. When Capecitabine and Cisplatin are used in combination, use of vitamin B6 (pyridoxine) is not advised for the symptomatic or secondary prophylactic treatment of hand-foot syndrome, because of published reports that it may decreases the efficacy of Cisplatin. There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Capecitabine.
Hepatic impairment: Capecitabine can induce hyperbilirubinemia. In the absence of safety and efficacy data in patients with hepatic impairment, Capecitabine use should be carefully monitored in patients with mild to moderate liver dysfunction, regardless of the presence or absence of liver metastasis. Administration of Capecitabine should be interrupted if treatment-related elevations in bilirubin of >3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of 2.5 x ULN occur. Treatment with Capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decreases to ≤2.5 x ULN. For combination treatment with Capecitabine and Docetaxel, see also Dosage & Administration.
Patients with hepatic impairment should be carefully monitored when Capecitabine is administered. The effect of hepatic impairment not due to liver metastases or severe hepatic impairment on the disposition of Capecitabine is not known.
Patient with hypo- or hypercalcemia.
Patient with central or peripheral nervous system disease.
Patient with diabetes mellitus or electrolyte disturbances.
Coumarin-derivative anticoagulant: Patient receiving concomitant Capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely and the anticoagulant dose adjusted accordingly.
Patient with renal impairment (creatinine clearance 30-50 mL/min).
As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ability to drive and use machine: Capecitabine has minor or moderate influence on the ability to drive and use machines. Capecitabine may cause dizziness, fatigue and nausea.