NIVESTYM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NIVESTYM (NIVESTYM).
Filgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) that binds to G-CSF receptors on hematopoietic cells, stimulating proliferation, differentiation, and release of neutrophils from bone marrow.
| Metabolism | Primarily renal clearance; degraded by proteolytic enzymes; not extensively metabolized by hepatic CYP450 enzymes. |
| Excretion | Primarily renal (via degradation to peptides and amino acids); <1% excreted unchanged. Biliary/fecal elimination is negligible. |
| Half-life | Terminal elimination half-life approximately 3.5 hours (subcutaneous) in healthy volunteers; in patients undergoing chemotherapy, half-life may be prolonged (up to 4-6 hours) due to neutrophil-mediated clearance. |
| Protein binding | Approximately 60-70% bound to albumin. |
| Volume of Distribution | Vd approximately 0.42-0.57 L/kg, indicating distribution primarily in plasma and interstitial fluid. |
| Bioavailability | Subcutaneous: approximately 50-60% of intravenous bioavailability; IV administration yields 100% bioavailability. |
| Onset of Action | Subcutaneous: Increase in neutrophil count observed within 1-2 hours; peak effect at 12-24 hours. Intravenous: Onset within 30-60 minutes. |
| Duration of Action | Single dose elevates neutrophil count for up to 24-48 hours; repeated daily dosing sustains effect during treatment cycle. Neutrophil count returns to baseline within 1-4 days after discontinuation. |
5 mcg/kg subcutaneously or intravenously once daily for up to 14 days until absolute neutrophil count reaches 10,000/mm³ after nadir; or 5 mcg/kg subcutaneously once daily for 5 days for mobilization of peripheral blood progenitor cells.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment recommended. Use with caution in severe renal impairment (CrCl < 30 mL/min) as clearance may be reduced. |
| Liver impairment | No specific dose adjustment recommended based on Child-Pugh score. Limited data in severe hepatic impairment. |
| Pediatric use | 5 mcg/kg subcutaneously or intravenously once daily. No weight-based adjustment beyond standard dosing. |
| Geriatric use | No specific dose adjustment required. Monitor closely for adverse effects (e.g., bone pain, splenic rupture) as elderly may be more sensitive. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NIVESTYM (NIVESTYM).
| Breastfeeding | It is not known whether filgrastim is excreted in human breast milk. Caution should be exercised when administered to a nursing woman. M/P ratio: unknown. |
| Teratogenic Risk | Animal studies have not shown evidence of fetal harm. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. |
| Fetal Monitoring | Monitor complete blood count (CBC) including absolute neutrophil count (ANC) regularly. Assess for signs of infection. Monitor spleen size via ultrasound if splenic enlargement suspected. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to filgrastim or its components","Concurrent administration with chemotherapy or radiation therapy (per labeling, but used cautiously)"]
| Precautions | ["Allergic reactions including anaphylaxis","Splenic rupture (reported with rapid neutrophil recovery)","Acute respiratory distress syndrome (ARDS)","Sickle cell crises in patients with sickle cell trait or disease","Glomerulonephritis","Leukocytosis","Capillary leak syndrome","Thrombocytopenia","Theoretical risk of tumor growth stimulation (monitor for signs/symptoms in myeloid malignancies)"] |
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| Fertility Effects | No known adverse effects on fertility in animal studies. Human data limited. |