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In rabbits, a dose of 20 mg/ kg/ day (240 mg/ m 2 , about twice the recommended dose in humans on a mg/ m 2 basis) caused reduced fetal weight. There are no adequate and well- controlled studies in pregnant women using IRESSA. If IRESSA is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy. PRECAUTIONS Hepatotoxicity Text Continues Below
Asymptomatic increases in liver transaminases have been observed in IRESSA-treated patients; therefore, periodic liver function (transaminases, bilirubin, and alkaline phosphatase) testing should be considered. Discontinuation of IRESSA should be considered if changes are severe. Patients with Hepatic Impairment In vitro and in vivo evidence suggest that gefitinib is cleared primarily by the liver. Therefore, gefitinib exposure may be increased in patients with hepatic dysfunction. In patients with liver metastases and moderately to severely elevated biochemical liver abnormalities, however, gefitinib pharmacokinetics were similar to the pharmacoki-netics of individuals without liver abnormalities (see CLINICAL PHARMACOLOGY-Pharmacokinetics- Special Populations section). The influence of non- cancer related hepatic impairment on the pharmacokinetics of gefitinib has not been evaluated. Information for Patients Patients should be advised to seek medical advice promptly if they develop 1) severe or persistent diarrhea, nausea, anorexia, or vomiting, as these have sometimes been associated with dehydration; 2) an onset or worsening of pulmonary symptoms, ie, shortness of breath or cough; 3) an eye irritation; or, 4) any other new symptom (see WARNINGS-Pulmonary Toxicity, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION-Dosage Adjustment sections). F. P. O. CONTINUED ON REVERSE SIDE Rev 05/ 03 64202-00 (gefitinib tablets) (tm) (gefitinib tablets) (tm) 250 mg For Oncology Use Only 1 1 Page 2 Women of childbearing potential must be advised to avoid becoming pregnant (see WARNINGS-Pregnancy Category D). Drug Interactions Substances that are inducers of CYP3A4 activity increase the metabolism of gefitinib and decrease its plasma concentrations. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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