Simultaneous Use with Chemotherapy and Radiation Therapy: The safety and efficacy of Recombinant G-CSF given simultaneously with cytotoxic chemotherapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, do not use Recombinant G-CSF in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy.
The safety and efficacy of Recombinant G-CSF have not been evaluated in-patients receiving concurrent radiation therapy. Simultaneous use of Recombinant G-CSF with chemotherapy and radiation therapy should be avoided.
The safety of Recombinant G-CSF in chronic myeloid leukemia (CML) and myelodysplasia has not been established.
Leukocytosis: White blood cell counts of 100,000/mm3 or greater are observed in approximately 2% of patients receiving Recombinant G-CSF at doses above 5 mcg/kg/day. There were no reports of adverse events associated with this degree of leukocytosis. In order to avoid the potential complications of excessive leukocytosis, a CBC is recommended twice per week during Recombinant G-CSF.
Cancer Patients Receiving Myelosuppressive Chemotherapy: A transient increase in neutrophil counts is typically seen 1 to 2 days after initiation of Recombinant G-CSF therapy. However, for a sustained therapeutic response, Recombinant G-CSF therapy should be continued following chemotherapy until the post nadir ANC reaches 10,000/mm3.
Increases are observed in serum uric acid, lactic dehydrogenase, and serum alkaline phosphatase.
Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of Recombinant G-CSF has not been studied. Recombinant G-CSF failed to induce bacterial gene mutations in either the presence or absence of a drug metabolizing enzyme system. Recombinant G-CSF had no observed effect on the fertility of male or female rats, or on gestation at doses up to 500 mcg/kg.
Use in Elderly: No overall differences in safety or effectiveness are observed between elderly and younger subjects.