Patients being treated with SEDOL must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported.
Dose-limiting bone marrow suppression is the most significant toxicity associated with SEDOL therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of SEDOL: Platelet count, hemoglobin, white blood cell count, therapy should be suspended if the platelet count is less than 50,000 mm3 or the absolute neutrophil count is less than 500 mm3.
Physicians should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension.
SEDOL (Etoposide Injection USP) is contraindicated in severe bone marrow failure not due to malignant disease and severe hepatic dysfunction.
Sedol may cause severe harm, it should only be administered under the supervision of qualified physician.
SEDOL contains benzyl alcohol therefore it is prohibited in children below 2 years old.
Etoposide should be given only by slow intravenous infusion (usually over a 30 to 60 minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection. Etoposide can cause fetal harm when administered to a pregnant woman. Etoposide has been shown to be teratogenic in mice and rats. Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus. Patients with low serum albumin may be at high/increased risk for Etoposide associated toxicities.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Etoposide For Injection contains polysorbate 80. In premature infants, a life-threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin E product containing polysorbate 80. Anaphylactic reactions have been reported in pediatric patients.