UDENYCA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for UDENYCA (UDENYCA).
Udenyca is a recombinant human granulocyte colony-stimulating factor (G-CSF) analog that stimulates the production and release of neutrophils from the bone marrow by binding to G-CSF receptors, thereby increasing neutrophil counts and reducing febrile neutropenia risk.
| Metabolism | Metabolism is not fully characterized; presumed to undergo catabolism to small peptides and amino acids via general protein degradation pathways. |
| Excretion | Primarily renal: approximately 62% of the dose excreted unchanged in urine; biliary/fecal elimination accounts for <10%. |
| Half-life | Terminal elimination half-life approximately 3.5 to 4.0 hours in healthy adults; supports daily dosing schedule. |
| Protein binding | Approximately 60-70% bound to serum albumin. |
| Volume of Distribution | Approximately 0.5 L/kg; indicates distribution primarily within extracellular fluid. |
| Bioavailability | Subcutaneous: approximately 60-70% relative to intravenous administration. |
| Onset of Action | Subcutaneous injection: neutrophil count begins to rise within 12-24 hours. |
| Duration of Action | Neutrophil elevation persists for approximately 24-48 hours after a single dose; clinical effect lasts until neutrophil count nadir recovery. |
5 mcg/kg subcutaneously once daily until absolute neutrophil count reaches 10,000/mm³ after nadir; administered at least 24 hours after cytotoxic chemotherapy.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | 5 mcg/kg subcutaneously once daily; safety and efficacy established for pediatric patients receiving myelosuppressive chemotherapy. |
| Geriatric use | No specific dose adjustment recommended; clinical studies included patients ≥65 years with similar efficacy and safety. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for UDENYCA (UDENYCA).
| Breastfeeding | Unknown if excreted in human milk. Endogenous G-CSF is present in breast milk. M/P ratio not determined. Consider developmental and health benefits of breastfeeding along with mother's clinical need for UDENYCA and potential adverse effects on nursing infant (e.g., neutropenia). |
| Teratogenic Risk | Pregnancy Category C. In animal studies, pegfilgrastim (the active ingredient) caused increased embryofetal mortality, reduced fetal weight, and skeletal anomalies at doses equivalent to human exposure. No adequate human studies. First trimester: potential risk unknown; second and third trimesters: possible immune-mediated effects on fetal granulopoiesis. Use only if potential benefit justifies risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["History of serious allergic reactions to pegfilgrastim products (including UDENYCA) or filgrastim products."]
| Precautions | ["Splenic rupture (discontinue if suspected) - monitor for left upper quadrant pain or shoulder tip pain.","Acute respiratory distress syndrome (ARDS) - evaluate if fever, lung infiltrates, or respiratory distress develop.","Allergic reactions, including anaphylaxis.","Sickle cell crisis in patients with sickle cell trait or disease.","Leukocytosis - monitor CBC regularly.","Capillary leak syndrome - monitor for hypotension, hypoalbuminemia, edema.","Aortitis - evaluate for signs of systemic inflammation."] |
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| Fetal Monitoring | Monitor maternal blood counts (complete blood count with differential) before and during therapy. Assess for splenic rupture (abdominal pain), acute respiratory distress syndrome, allergic reactions, and sickle cell crisis. For fetus, no specific monitoring indicated; consider ultrasound for growth if used in second/third trimester. |
| Fertility Effects | No specific studies in humans. In animal studies, pegfilgrastim did not affect fertility in rats. Theoretical concern for ovarian suppression due to cytokine effects, but no clinical data. |