ROLVEDON
Clinical safety rating
cautionComprehensive clinical and safety monograph for ROLVEDON (ROLVEDON).
ROLVEDON (eflapegrastim) is a long-acting granulocyte colony-stimulating factor (G-CSF) agonist. It binds to G-CSF receptors on neutrophil progenitors, stimulating proliferation, differentiation, and release of neutrophils from the bone marrow.
| Metabolism | Eflapegrastim is metabolized via catabolism into small peptides and amino acids. |
| Excretion | Primarily renal; approximately 80% of the dose excreted unchanged in urine, with minor biliary/fecal elimination (<10%) |
| Half-life | Approximately 20 hours in adults; prolonged in renal impairment, requiring dose adjustment |
| Protein binding | Approximately 60% bound to albumin and other plasma proteins |
| Volume of Distribution | Approximately 0.5 L/kg, indicating distribution largely confined to plasma and interstitial fluid |
| Bioavailability | Subcutaneous: approximately 100% bioavailability |
| Onset of Action | Delayed; clinical effect (neutrophil recovery) observed within 3–5 days after subcutaneous injection |
| Duration of Action | Sustained elevation of neutrophil counts for up to 7–10 days following a single dose; duration correlates with dose |
| Molecular Weight | 18800 |
5 mg subcutaneously once weekly.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, administer 5 mg subcutaneously once every 2 weeks. |
| Liver impairment | Child-Pugh A: No dose adjustment. Child-Pugh B: 5 mg subcutaneously once every 2 weeks. Child-Pugh C: Not recommended. |
| Pediatric use | Weight-based: For body weight <50 kg, 0.1 mg/kg subcutaneously once weekly; for ≥50 kg, 5 mg subcutaneously once weekly. |
| Geriatric use | No specific dose adjustment recommended. Monitor renal function and consider increased risk of infections due to age-related immune changes. |
| 1st trimester | Avoid use unless clearly needed; limited human data, animal studies show risk. |
| 2nd trimester | Use only if benefit outweighs risk; may cause fetal harm based on animal studies. |
| 3rd trimester | Use only if benefit outweighs risk; potential for neonatal myelosuppression. |
Clinical note
Comprehensive clinical and safety monograph for ROLVEDON (ROLVEDON).
| Placental transfer | Likely crosses placenta; molecular weight suggests transfer. |
| Breastfeeding | Not recommended during breastfeeding due to potential for serious adverse reactions in nursing infants; consider alternatives or discontinue nursing. |
| Lactation Rating | L4 (possibly hazardous) |
| Teratogenic Risk | No human data; animal studies not available; due to mechanism of action (G-CSF receptor agonist), potential for fetal harm cannot be excluded; avoid in pregnancy unless benefit outweighs risk. |
| Fetal Monitoring | Monitor complete blood count (CBC) including absolute neutrophil count (ANC) weekly during therapy; assess for splenic rupture (abdominal pain, left upper quadrant pain), respiratory distress syndrome, and allergic reactions. |
| Fertility Effects | No human data; animal studies not available; may affect ovarian function or spermatogenesis theoretically via cytokine modulation; clinical significance unknown. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to rolvepritug or any componentHistory of severe hypersensitivity reactions to pegfilgrastim or filgrastim
| Precautions | Splenic rupture, Acute respiratory distress syndrome (ARDS), Allergic reactions, including anaphylaxis, Sickle cell crisis in patients with sickle cell disease, Glomerulonephritis, Increased risk of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy, Capillary leak syndrome, Potential for tumor growth stimulatory effects on malignant cells |
| Food/Dietary | No known dietary restrictions or food interactions with Rolvedon. No effect of food on absorption as it is administered subcutaneously. |
| Clinical Pearls | Rolvedon (eflapegrastim) is a long-acting G-CSF administered as a fixed dose (13.2 mg subcutaneously) once per chemotherapy cycle, typically 24-72 hours after myelosuppressive chemotherapy. It does not require weight-based dosing. Monitor for splenic rupture, ARDS, and sickle cell crisis. Do not use within 14 days of chemotherapy administration. Store in refrigerator at 2-8°C; allow to reach room temperature before injection. It is a recombinant fusion protein and may have different immunogenicity profile compared to filgrastim. |
| Patient Advice | You will receive this injection 1 to 3 days after each chemotherapy session. · Common side effects include bone pain, muscle aches, and injection site reactions. · Report sudden abdominal or shoulder tip pain, as it may indicate spleen rupture. · Report signs of allergic reaction: rash, hives, swelling, difficulty breathing. · Do not use this medication if you have sickle cell disease without consulting your doctor. · Store in the refrigerator, but do not freeze. Let it sit at room temperature for 30 minutes before injection. · Do not shake the vial or prefilled syringe. |
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