General Simultaneous Use With Chemotherapy and Radiation Therapy: The safely and efficacy of FILGRASTIM (LEUCOGEN) given simultaneously with cytotoxic chemotherapy or concurrent radiation therapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, do not use FILGRASTIM (LEUCOGEN) in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy. Simultaneous use of FILGRASTIM (LEUCOGEN) with chemotherapy and radiation therapy should be avoided.
Potential Effect on Malignant Cells: FILGRASTIM (LEUCOGEN) is a growth factor that primarily stimulates neutrophils. However, the possibility that FILGRASTIM (LEUCOGEN) can act as a growth factor for any tumor type cannot be excluded. The safety of FILGRASTIM (LEUCOGEN) in chronic myeloid leukemia (CML) and myelodysplasia has not been established.
Leukocytosis: White blood cell counts of 100,000/mm3 or greater were observed in approximately 2% of cancer patients receiving myelosuppressive chemotherapy, treated with Filgrastim at doses above 3 mcg/kg/day. There were no reports of adverse events associated with this degree of leukocytosis.
Premature Discontinuation of Therapy: The interruption of the Filgrastim treatment produce a 50% decrease of the circulating neutrophils in a period of 1 to 2 days with a normalization in a period of 1 to 7 days. A transient increase in neutrophil counts is typically seen 1 to 2 days after initiation of FILGRASTIM (LEUCOGEN) therapy. However, for a sustained therapeutic response, FILGRASTIM (LEUCOGEN) therapy should be continued following chemotherapy until the post nadir ANC reaches 10,000/mm3.
Other Specials cautions should be taken during the administration of higher doses of chemotherapy because the patient may be at greater risk of cardiac, pulmonary, neurological and dermatological toxicities. FILGRASTIM (LEUCOGEN) do not avoid thrombocytopenia or anemia as consequence of myelosuppressive chemotherapy therefore regular monitoring of the hematocrit and platelet count is recommended, especially when chemotherapeutic agents or combinations of them with severe thrombocytopenic effect are administered. Bone density should be determined in patients with osteoporosis receiving FILGRASTIM (LEUCOGEN) for period longer than 6 months. FILGRASTIM (LEUCOGEN) is not recommended ln patients with severe hepatic or renal dysfunction. In septic patients receiving FILGRASTIM (LEUCOGEN), the physician should be alert to the possibility of adult respiratory distress syndrome, due to the possible influx of neutrophils at the site of inflammation.