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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. Therefore, the use of Filgrastim is not recommended in myeloid premalignant and malignant condition.
A white blood cell count should be performed at regular intervals during Filgrastim therapy. If leucocyte counts exceed 50 x 109/L after the expected nadir, Filgrastim should be discontinued immediately.
Monitoring of bone density may be indicated in patients with underlying osteoporotic bone disease who received Filgrastim. Studies have not been performed with Filgrastim in patients with severe impairment of renal or hepatic function and therefore, its use in this patient group cannot be recommended.
The safety of Filgrastim has not been established in children.
Simultaneous use with chemotherapy and radiation therapy: The safety and efficacy of Filgrastim have not been evaluated in patients receiving concurrent cytotoxic chemotherapy. However, because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, do not use Filgrastim in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy. The safety and efficacy of Filgrastim have not been evaluated in patients receiving concurrent radiation therapy. Simultaneous use of Filgrastim with chemotherapy and radiation therapy should be avoided.
Leukocytosis: In order to avoid the potential complications of excessive leukocytosis, a Complete Blood Count (CBC) is recommended twice per week during therapy of Filgrastim.
Use in Pregnancy and Lactation: The safety of Filgrastim has not been established in pregnant women. In pregnancy, the possible risk of Filgrastim use to the fetus must be weighed against the expected therapeutic benefit. It is not known whether Filgrastim is excreted in human milk, therefore Filgrastim is not recommended for use in nursing woman.
