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. |
| Molecular Weight | 39000 |
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 | Limited human data; animal studies show no evidence of harm, but use only if clearly needed. |
| 2nd trimester | Limited human data; potential risks include transient fetal neutropenia; use if benefit outweighs risk. |
| 3rd trimester | May cause transient fetal neutropenia and thrombocytopenia; reserve for severe maternal conditions. |
Clinical note
Comprehensive clinical and safety monograph for UDENYCA (UDENYCA).
| Placental transfer | Pegfilgrastim is a large molecule (39 kDa) and likely does not cross the placenta in significant amounts, but theoretical risk of transfer exists. |
| Breastfeeding | Not known if excreted in human milk; caution in nursing mothers due to potential for serious adverse reactions in nursing infants. |
| Lactation Rating |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to pegfilgrastim or any componentHistory of serious allergic reactions to filgrastim or pegfilgrastim
| 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. |
| Food/Dietary | No significant food interactions have been reported. No dietary restrictions are necessary. |
Loading safety data…
| L3 (Moderately Safe) |
| 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. |
| 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. |
| Clinical Pearls | UDENYCA (pegfilgrastim-cbqv) is a biosimilar of pegfilgrastim. Administer subcutaneously once per chemotherapy cycle, at least 24 hours after cytotoxic chemotherapy and at least 14 days before the next cycle. Do not administer within 14 days before or 24 hours after chemotherapy to avoid increased myelotoxicity. Monitor for bone pain, which may be managed with NSAIDs or acetaminophen. Splenic rupture and acute respiratory distress syndrome (ARDS) are rare but serious adverse effects. Ensure proper storage at 2°C to 8°C; do not shake. |
| Patient Advice | Take this injection exactly as prescribed, usually once per chemotherapy cycle. · Do not receive this injection within 24 hours before or after chemotherapy. · Common side effects include bone pain, which can be managed with over-the-counter pain relievers like acetaminophen or ibuprofen. · Seek immediate medical attention if you experience severe left upper abdominal pain, shoulder tip pain, or shortness of breath, as these could indicate splenic rupture or ARDS. · This medicine is a clear, colorless solution; do not use if it appears cloudy or contains particles. · Store in the refrigerator, do not freeze, and protect from light. Do not shake the vial or prefilled syringe. |