OMONTYS PRESERVATIVE FREE
Clinical safety rating
cautionComprehensive clinical and safety monograph for OMONTYS PRESERVATIVE FREE (OMONTYS PRESERVATIVE FREE).
Epoetin alfa-epbx is a recombinant human erythropoietin that stimulates erythropoiesis by binding to and activating the erythropoietin receptor on erythroid progenitor cells, promoting their survival, proliferation, and differentiation.
| Metabolism | Epoetin alfa-epbx is a protein; its metabolism is not fully characterized but expected to undergo catabolism via proteolysis into small peptides and amino acids. |
| Excretion | Primarily renal: approximately 60% of the dose excreted unchanged in urine; biliary/fecal elimination is a minor route (<10%). |
| Half-life | Terminal elimination half-life is approximately 24–30 hours in patients with chronic kidney disease on dialysis; longer half-life may occur in patients with residual renal function. |
| Protein binding | Approximately 60–70% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Approximately 0.05–0.07 L/kg, suggesting limited extravascular distribution primarily within plasma volume. |
| Bioavailability | Subcutaneous injection: approximately 50% (range 40–60%) relative to intravenous administration. |
| Onset of Action | Subcutaneous injection: reticulocyte count begins to increase within 1–2 weeks; hemoglobin rise is typically observed after 2–4 weeks of weekly dosing. |
| Duration of Action | Duration of erythropoietic effect lasts approximately 1–2 weeks after a single dose, supporting weekly dosing; clinical effect wanes if dosing is interrupted. |
| Molecular Weight | 800 |
The recommended dose of OMONTYS (pegcetacoplan) for paroxysmal nocturnal hemoglobinuria (PNH) is 1080 mg subcutaneously twice weekly via a proprietary infusion pump.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment is required for patients with renal impairment, including those on dialysis, as renal clearance is negligible. |
| Liver impairment | No dedicated hepatic impairment studies have been conducted; however, pegcetacoplan is a large peptide not metabolized by the liver, so no adjustment is expected for mild to moderate hepatic impairment. Use with caution in severe hepatic impairment due to lack of data. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; no dose guidelines are available. |
| Geriatric use | No specific dose adjustment is recommended for elderly patients based on age alone; however, consider comorbidities and monitor for adverse events. |
| 1st trimester | No human data; animal studies show no evidence of fetal harm. Use only if clearly needed. |
| 2nd trimester | No human data; animal studies show no evidence of fetal harm. Use only if clearly needed. |
| 3rd trimester | No human data; animal studies show no evidence of fetal harm. Use only if clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for OMONTYS PRESERVATIVE FREE (OMONTYS PRESERVATIVE FREE).
| Placental transfer | Not studied in humans; based on molecular weight (~800 Da), potential for transfer is low but unknown. |
| Breastfeeding | Not known if excreted in human milk; caution advised due to potential for adverse reactions in nursing infants. |
| Lactation Rating | L3 - Limited data; potential risk. |
| Teratogenic Risk | No human data. In animal studies, no teratogenic effects observed at doses up to 20 times the human exposure. Risk cannot be excluded; use only if clearly needed. |
| Fetal Monitoring | Monitor hemoglobin and hematocrit periodically. Assess for signs of thrombosis, hypertension, and preeclampsia. Fetal growth monitoring by ultrasound recommended. |
| Fertility Effects | No human data. Animal studies show no impairment of fertility at doses up to 20 times human exposure. |
■ FDA Black Box Warning
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Use the lowest dose to avoid red blood cell transfusion. For patients with CKD, control hemoglobin levels no higher than 11 g/dL. Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy and when the expected outcome is cure (not for palliative setting).
| Serious Effects |
Hypersensitivity to epoetin alfa-epbx or any component of the formulation
| Precautions | Increased risk of serious cardiovascular events (e.g., myocardial infarction, stroke, thromboembolism) when targeting hemoglobin > 11 g/dL, Hypertension; monitor and control blood pressure, Increased risk of seizures, especially during the first 90 days of treatment, Pure red cell aplasia (PRCA) and severe anemia upon neutralizing antibodies to erythropoietin; discontinue if PRCA develops, Increased mortality and serious cardiovascular events in patients with cancer not receiving chemotherapy, Increased risk of tumor progression or recurrence in patients with cancer; use only for chemotherapy-induced anemia with curative intent, May increase the risk of thrombotic events, including venous thromboembolism and vascular access thrombosis, Laboratory monitoring: hemoglobin, blood pressure, iron stores |
| Food/Dietary | No known food interactions. However, iron supplementation may be required; avoid taking iron supplements with dairy, calcium-rich foods, or caffeine to enhance absorption. Follow renal diet restrictions as advised by your healthcare provider (e.g., limit potassium, phosphorus, sodium). |
| Clinical Pearls | OMONTYS (eptidein alfa) is an erythropoietin receptor agonist for anemia in chronic kidney disease (CKD). In patients with iron deficiency, functional or absolute, initiate iron repletion prior to therapy. Monitor hemoglobin weekly until stable, then monthly; target Hb 10-11 g/dL. Do not use in patients with uncontrolled hypertension, history of pure red cell aplasia, or hypersensitivity. Administer subcutaneously; rotation of injection sites is recommended. Monitor for thrombotic events especially in those with cardiovascular disease. Not approved for use in patients undergoing elective surgery. |
| Patient Advice | OMONTYS is used to treat anemia caused by chronic kidney disease. It helps your body make more red blood cells. · You will receive injections under the skin, usually once every 2 or 4 weeks as directed by your doctor. · Do not shake the prefilled syringe. Store in the refrigerator, do not freeze. Protect from light. · If you miss a dose, call your doctor as soon as possible. Do not double the dose. · Report any signs of allergic reaction (rash, hives, difficulty breathing) or blood clots (pain, swelling, redness in legs, chest pain, sudden shortness of breath). · Your doctor will check your blood pressure and hemoglobin levels regularly. Do not adjust your dose without consulting your doctor. · There are no specific food restrictions, but maintain a balanced diet as recommended for kidney disease. |
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