Simultaneous use with Chemotherapy and Radiation Therapy: Since the safety and efficacy of Filgrastim given concomitantly with cytotoxic chemotherapy and radiation therapy has not been established, it is advisable that simultaneous use of Filgrastim with chemotherapy and radiation therapy should be avoided. In patients receiving cytotoxic drugs, for 24 hrs prior to and 24 hrs after chemotherapy, Filgrastim administration should be avoided, since the sensitivity of fast proliferating neutrophils to chemotherapy is not established.
Potential Effect on Malignant Cells: Filgrastim is a growth factor that primarily stimulates neutrophils. However, the possibility that Filgrastim can act as a growth factor for any tumor type cannot be excluded.
Use in Pregnancy: Since there are no adequate and well-controlled studies in pregnant women, the effect, if any, of Filgrastim on the developing fetus or the reproductive capacity of the mother is unknown. Filgrastim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: It is not known whether Filgrastim is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Filgrastim is administered to a nursing woman.
Use in Children: The safety profile of Filgrastim in pediatric patients appears similar to that reported in adults. The safety and efficacy in neonates and patients with autoimmune neutropenia of infancy have not been established. As rhG-CSF can cause increased uric acid levels, patients who have a history of gout or malignancies that are known to be associated with increased uric acid levels, should be monitored regularly.