OMONTYS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMONTYS (OMONTYS).
Erythropoiesis-stimulating agent; synthetic peptide agonist of the erythropoietin receptor (EPOR) that stimulates erythropoiesis in red blood cell precursors.
| Metabolism | Not metabolized by cytochrome P450 enzymes; degraded into small peptides and amino acids via catabolic pathways. |
| Excretion | Primarily eliminated via the reticuloendothelial system; no significant renal or biliary excretion. The iron component is incorporated into hemoglobin or stored as ferritin/hemosiderin. |
| Half-life | Terminal elimination half-life is approximately 14.5 hours in healthy adults; in hemodialysis patients, half-life is extended to 26.4–29.9 hours, supporting weekly dosing. |
| Protein binding | Ferric pyrophosphate citrate moiety: <5% bound to plasma proteins; iron is rapidly transferred to transferrin. |
| Volume of Distribution | Vd approximately 0.47 L/kg (range 0.2–0.8 L/kg), indicating distribution primarily into plasma and interstitial fluid; iron distributes to bone marrow and reticuloendothelial system. |
| Bioavailability | Not applicable; OMONTYS is administered only intravenously. Oral bioavailability is not relevant. |
| Onset of Action | Intravenous administration: hemoglobin rise observed within 1–2 weeks; reticulocyte count increase within 7–10 days. |
| Duration of Action | Hemoglobin levels maintained for up to 4 weeks following a single IV dose; weekly dosing regimen sustains correction of iron deficiency anemia in hemodialysis patients. |
45 mg subcutaneously once every 4 weeks (monthly) in adults.
| Dosage form | SOLUTION |
| Renal impairment | No dosage adjustment required for any degree of renal impairment, including end-stage renal disease. |
| Liver impairment | No dosage adjustment recommended for mild or moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; no recommended dose. |
| Geriatric use | No specific dosage adjustment needed; consider age-related renal function and individual tolerability. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMONTYS (OMONTYS).
| Breastfeeding | It is unknown whether pegcetacoplan is excreted in human milk, affects the breastfed infant, or affects milk production. No data on the milk-to-plasma (M/P) ratio are available. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | OMONTYS (pegcetacoplan) is a complement inhibitor. There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, no adverse developmental effects were observed at maternal exposures up to 20 times the human exposure at the recommended clinical dose. Based on its mechanism of action as a complement inhibitor, there is a theoretical risk of increased susceptibility to infections for the fetus, but no specific teratogenic effects have been identified. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. |
■ FDA Black Box Warning
Increased risk of serious cardiovascular events, myocardial infarction, stroke, venous thromboembolism, vascular access thrombosis, and mortality when targeting hemoglobin levels >11 g/dL; increased risk of tumor progression and recurrence in patients with cancer; not indicated for treatment of anemia in cancer patients due to increased risk of death and serious cardiovascular events.
| Serious Effects |
Uncontrolled hypertension; history of pure red cell aplasia (PRCA) following erythropoiesis-stimulating agents; known hypersensitivity to OMONTYS or any of its components.
| Precautions | Increased mortality, serious cardiovascular events, and thromboembolic events; hypertension; seizures; pure red cell aplasia (PRCA) with neutralizing antibodies; increased risk of tumor progression in cancer patients; hemoglobin monitoring; iron deficiency management; hypersensitivity reactions including anaphylaxis. |
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| Fetal Monitoring | Monitor for signs and symptoms of infection, including encapsulated bacteria (e.g., Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae). Fetal monitoring with standard prenatal care (ultrasound, fetal growth assessment) is recommended. Ensure appropriate vaccination status (e.g., meningococcal vaccine) prior to conception if possible. Monitor maternal complement activity and complete blood count (CBC) as per usual clinical practice. No specific fetal monitoring beyond routine obstetric care is indicated. |
| Fertility Effects | There are no human data on the effect of pegcetacoplan on fertility. In animal studies, no adverse effects on male or female fertility were observed at exposures up to 20 times the human exposure. The drug is not expected to impair fertility based on its mechanism of action, but these data are limited. |