rapy (see DOSAGE AND ADMINISTRATION) because of the potential for an increase in sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy.
The use of Neulasta® has not been studied in patients receiving chemotherapy associated with delayed myelosuppression (eg, nitrosoureas, mitomycin C).
The administration of Neulasta® concomitantly with 5‑fluorouracil or other antimetabolites has not been eva luated in patients. Administration of pegfilgrastim at 0, 1, and 3 days before 5‑fluorouracil resulted in increased mortality in mice; administration of pegfilgrastim 24 hours after 5‑fluorouracil did not adversely affect survival.
The use of Neulasta® has not been studied in patients receiving radiation therapy.
Potential Effect on Malignant Cells
Pegfilgrastim is a growth factor that primarily stimulates neutrophils and neutrophil precursors; however, the G‑CSF receptor through which pegfilgrastim and Filgrastim act has been found on tumor cell lines, including some myeloid, T‑lymphoid, lung, head and neck, and bladder tumor cell lines. The possibility that pegfilgrastim can act as a growth factor for any tumor type cannot be excluded. Use of Neulasta® in myeloid malignancies and myelodysplasia (MDS) has not been studied. In a randomized study comparing the effects of the parent compound of Neulasta®, Filgrastim, to placebo in patients undergoing remission induction and consolidation chemotherapy for acute myeloid leukemia, important differences in remission rate between the two arms were excluded. Disease‑free survival and overall survival were comparable; however, the study was not designed to detect important differences in these endpoints.3
Information for Patients
Patients should be informed of the possible side effects of Neulasta®, and be instructed to report them to the prescribing physician. Patients should be informed of the signs and symptoms of allergic drug reactions and be advised of appropriate actions. Patients should be counseled on the importance of compliance with their Neulasta® treatment, including regular monitoring of blood counts.
If it is determined that a patient or caregiver can safely and effectively administer Neulasta® (pegfilgrastim) at home, appropriate instruction on the proper use of Neulasta® (pegfilgrastim) should be provided for patients and their caregivers, including careful review of the “Information for Patients and Caregivers” insert. Patients and caregivers should be cautioned against the reuse of needles, syringes, or drug product, and be thoroughly instructed in their proper disposal. A puncture-resistant container for the disposal of used syringes and needles should be available.
Laboratory Monitoring
To assess a patient’s hematologic status and ability to tolerate myelosuppressive chemotherapy, a complete blood count and platelet count should be obtained before chemotherapy is administered. Regular monitoring of hematocrit value and platelet count is recommended.
Drug Interaction
No formal drug interaction studies between Neulasta® and other drugs have been performed. Drugs such as lithium may potentiate the release of neutrophils; patients receiving lithium and Neulasta® should have more frequent monitoring of neutrophil counts.
Increased hematopoetic activity of the bone marrow in response to growth factor therapy has been associated |
