Capvex 500 Special Precautions

A physician experienced in the use of cancer chemotherapeutic agents should monitor patients receiving therapy with Capecitabine. Most adverse events are reversible and do not need to result in discontinuation, although doses may need to be withheld or reduced.
Hand-and-Foot Syndrome: Hand-and-foot syndrome (palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema) may occur.
If grade 2 or 3 hand-and-foot syndrome occurs, administration of Capecitabine should be interrupted until the event resolve or decreases in intensity to grade 1. Following grade 3 hand-and-foot syndrome, subsequent doses of Capecitabine should be decreased.
Capecitabine is not known.
Cardiac: There has been cardiotoxicity associated with fluorinated pyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiograph changes. These adverse events may be more common in patients with a prior history of coronary artery disease.
Drug-Food Interaction: Since current safety and efficacy data are based upon administration of Capecitabine with food, it is recommended that Capecitabine be administered with food.
Hematologic: Capecitabine can lead to neutropenia, thrombocytopenia and decreases in hemoglobin.
Hepatic Insufficiency: Patients with mild to moderate hepatic dysfunction due to liver metastases should be carefully monitored when Capecitabine is administered.
The effect of severe hepatic dysfunction on the disposition of Capecitabine should decrease.
Hyperbilirubinemia: If drug related grade 2-4 elevations in bilirubin occur, administration of Capecitabine should be immediately interrupted until the Hyperbilirubinemia resolves or decreases in intensity to grade 1.
Renal Insufficiency: There is little experience in patients with renal impairment. Physicians should exercise caution when Capecitabine is administered.
Carcinogenesis and Mutagenesis: Long-term studies in animals to evaluate the carcinogenic potential of Capecitabine have not been conducted. Capecitabine has not been shown to be mutagenic in vitro or in vivo.
Impairment of Fertility: Capecitabine causes a decrease in fertility by disturbing the estrus. In male mice, Capecitabine causes degenerative changes in the testes, including decreases in the number of spermatocytes and spermatids.
Nursing mother: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued when receiving Capecitabine therapy.
Use in children: The safety and effectiveness of Capecitabine in persons < 18 years of age have not been established.
Use in the elderly:Patients >/=80 years old may experience a greater incidence of gastrointestinal grade 4 or 4 adverse events. Physicians should pay particular attention to monitoring the adverse effects of Capecitabine in the elderly.