Abseamed (Epoetin Alfa): Uses, Dosage & Side Effects
Biosimilar erythropoietin for the treatment of anemia
Quick Facts About Abseamed
Key Takeaways About Abseamed
- Biosimilar erythropoietin: Abseamed is a biosimilar of the reference medicine Eprex/Erypo, containing epoetin alfa that stimulates red blood cell production in the bone marrow
- Three main indications: Used for anemia in chronic kidney disease (dialysis and pre-dialysis), chemotherapy-induced anemia, and to reduce blood transfusion needs before major surgery
- Target hemoglobin matters: Hemoglobin should not exceed 12 g/dL during treatment; higher levels increase the risk of cardiovascular events including stroke and blood clots
- Iron supplementation is essential: Adequate iron stores are necessary for Abseamed to work effectively; iron status should be monitored and supplemented throughout treatment
- Regular monitoring required: Blood pressure and hemoglobin levels must be checked regularly during treatment to ensure safety and optimal dosing
What Is Abseamed and What Is It Used For?
Quick Answer: Abseamed is a biosimilar medicine containing epoetin alfa, a laboratory-produced version of the human hormone erythropoietin. It stimulates the bone marrow to produce more red blood cells and is primarily used to treat anemia in chronic kidney disease, chemotherapy-induced anemia, and to reduce blood transfusion requirements before major surgery.
Abseamed belongs to a class of medicines known as erythropoiesis-stimulating agents (ESAs). Its active substance, epoetin alfa, is a glycoprotein produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. It is structurally and functionally identical to the naturally occurring hormone erythropoietin, which is primarily produced by the kidneys and plays a central role in regulating red blood cell production.
Erythropoietin is essential for the body's ability to transport oxygen. When the kidneys detect low oxygen levels in the blood, they release erythropoietin, which travels to the bone marrow and signals erythroid progenitor cells to proliferate and differentiate into mature red blood cells (erythrocytes). In patients with chronic kidney disease, the kidneys lose the ability to produce adequate amounts of erythropoietin, leading to a progressive decline in red blood cell count and the development of anemia. Abseamed replaces this missing hormone, restoring the body's capacity to produce red blood cells.
Abseamed was approved by the European Medicines Agency (EMA) as a biosimilar of the reference medicine Eprex/Erypo. A biosimilar is a biological medicine that is highly similar to another biological medicine (the reference medicine) that has already been authorized. Extensive clinical studies have demonstrated that Abseamed is comparable to its reference medicine in terms of quality, safety, and efficacy. The EMA authorization process for biosimilars is rigorous and ensures that patients can expect the same therapeutic outcomes as with the original product.
Approved Indications
Abseamed is authorized for the following indications:
- Chronic kidney disease (CKD): Treatment of symptomatic anemia in adult patients on hemodialysis, adult patients on peritoneal dialysis, and adult patients with renal insufficiency not yet on dialysis (pre-dialysis). In pediatric patients aged 1-18 years on hemodialysis, it is used for the treatment of symptomatic anemia.
- Chemotherapy-induced anemia: Treatment of anemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumors, malignant lymphoma, or multiple myeloma who are at risk of transfusion based on their general condition (e.g., cardiovascular status, pre-existing anemia at the start of chemotherapy).
- Autologous blood predonation: To increase the yield of autologous blood from patients in a predonation program, where this blood will be used in planned major elective surgery that is expected to require a large volume of blood.
- Reduction of allogeneic blood transfusions: To reduce exposure to allogeneic blood transfusions in adult patients without iron deficiency who are scheduled for major elective orthopedic surgery and are considered at high risk of transfusion complications.
The choice of indication and dosing must always be made by a qualified healthcare professional who can assess the individual patient's clinical situation, including hemoglobin levels, iron status, and overall health condition. Self-medication with erythropoietin-based products is not appropriate and can lead to serious complications.
What Should You Know Before Taking Abseamed?
Quick Answer: Abseamed should not be used if you have uncontrolled high blood pressure, are at risk of blood clots, or have pure red cell aplasia. It requires careful monitoring of blood pressure and hemoglobin levels. Iron stores must be adequate before and during treatment.
Contraindications
Abseamed must not be used in the following situations:
- Uncontrolled hypertension: Patients with poorly controlled high blood pressure must not start treatment with Abseamed. Blood pressure should be adequately controlled before initiating therapy and monitored closely throughout treatment.
- Hypersensitivity: Known hypersensitivity to epoetin alfa or any of the excipients (inactive ingredients) is an absolute contraindication. Patients who have previously experienced severe allergic reactions to any erythropoietin product should not receive Abseamed.
- Pure red cell aplasia (PRCA): Patients who have developed PRCA following previous treatment with any erythropoietin must not receive Abseamed or any other erythropoietin product. PRCA is a rare but serious condition in which the body produces antibodies against erythropoietin, effectively stopping all red blood cell production.
- High risk of thromboembolic events: In the surgical setting, patients who cannot receive adequate antithrombotic prophylaxis for medical reasons should not be treated with Abseamed.
Targeting hemoglobin levels above 12 g/dL (7.5 mmol/L) with erythropoiesis-stimulating agents, including Abseamed, has been associated with an increased risk of death, serious cardiovascular events (including stroke, myocardial infarction, and congestive heart failure), and thromboembolic events (including deep vein thrombosis and pulmonary embolism). Always use the lowest dose sufficient to reduce the need for red blood cell transfusions.
Warnings and Precautions
Treatment with Abseamed requires careful medical supervision. Before and during treatment, your healthcare provider should consider the following precautions:
- Blood pressure monitoring: Hypertension is one of the most common side effects of erythropoietin therapy. Blood pressure should be monitored regularly and treated adequately. If blood pressure becomes difficult to control, the dose of Abseamed may need to be reduced or treatment temporarily interrupted. In rare cases, hypertensive crisis with encephalopathy-like symptoms (headache, confusion, seizures) may occur.
- Hemoglobin monitoring: Hemoglobin levels should be measured regularly (at least every two weeks during dose adjustment and at least monthly during maintenance therapy). The rate of hemoglobin increase should not exceed 2 g/dL per month to minimize the risk of hypertension and thromboembolic complications. Target hemoglobin should be individualized but generally should not exceed 10-12 g/dL.
- Iron status: Iron deficiency is the most common cause of a poor response to erythropoietin therapy. Transferrin saturation and serum ferritin should be evaluated before starting treatment and regularly during therapy. Iron supplementation is generally recommended for all patients with transferrin saturation below 20% or serum ferritin below 100 ng/mL.
- Thrombosis risk: There is an increased risk of thrombotic vascular events during erythropoietin therapy, particularly during the early phase when hemoglobin is rising rapidly. Patients with pre-existing cardiovascular disease, a history of thrombosis, or other risk factors should be monitored closely.
- Epilepsy and seizures: Erythropoietin has been associated with seizures, particularly in patients with chronic kidney disease. Caution should be used in patients with a history of seizure disorders.
- Hepatic impairment: The safety and efficacy of epoetin alfa in patients with hepatic dysfunction have not been established. Caution should be exercised in this population.
- Potassium levels: Mild increases in serum potassium have been observed during epoetin alfa therapy, particularly in patients with chronic kidney disease. Potassium levels should be monitored, especially in patients receiving concomitant medications that may increase potassium levels.
Pregnancy and Breastfeeding
There are limited clinical data regarding the use of Abseamed during pregnancy. Animal studies have shown reproductive toxicity at very high doses. Because of the potential risks, Abseamed should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment.
It is not known whether epoetin alfa is excreted in human breast milk. A risk to the breastfed infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Abseamed treatment, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your healthcare provider for advice before using this medicine.
How Does Abseamed Interact with Other Drugs?
Quick Answer: Abseamed may interact with cyclosporine (increased blood levels), anticoagulants like heparin (may require dose adjustments), and ACE inhibitors (may reduce response to erythropoietin). Iron supplements are essential for optimal response. Always inform your healthcare provider about all medicines you are taking.
While epoetin alfa itself has relatively few direct drug-drug interactions compared to many small-molecule drugs, several important interactions and considerations should be noted. The pharmacological effects of Abseamed can influence the metabolism and efficacy of certain other medications, and conversely, some drugs may alter the response to erythropoietin therapy.
| Interacting Drug | Type | Effect | Clinical Recommendation |
|---|---|---|---|
| Cyclosporine | Major | Increased cyclosporine binding to red blood cells may raise blood levels | Monitor cyclosporine blood levels and adjust dose as needed |
| Heparin & anticoagulants | Moderate | Rising hematocrit may require increased heparin dose during dialysis; risk of clotting in dialysis lines | Adjust heparin dose based on hematocrit; monitor for clotting in dialysis circuit |
| ACE inhibitors | Moderate | May reduce the response to erythropoietin, possibly through effects on erythropoietin production or iron metabolism | Monitor hemoglobin response; higher EPO doses may be needed |
| Iron supplements | Beneficial | Adequate iron stores are essential for erythropoietin response; iron deficiency limits red blood cell production | Supplement iron (oral or IV) to maintain transferrin saturation >20% and ferritin >100 ng/mL |
| Antihypertensive medications | Moderate | Blood pressure may rise during EPO treatment, potentially counteracting antihypertensive effects | Monitor blood pressure frequently; adjust antihypertensive therapy as needed |
Major Interactions
Cyclosporine is the most clinically significant drug interaction with Abseamed. As hemoglobin and hematocrit rise during erythropoietin treatment, cyclosporine binding to red blood cells increases, potentially leading to higher cyclosporine blood levels and increased toxicity. This is particularly relevant for kidney transplant recipients and other patients on immunosuppressive therapy. Regular monitoring of cyclosporine trough levels is essential, and dose adjustments may be needed during the first months of erythropoietin therapy.
Erythropoietin therapy may also increase the risk of thromboembolic events in patients already at elevated risk due to hormonal contraceptives, hormone replacement therapy, or other prothrombotic medications. Healthcare providers should assess the overall thrombotic risk profile when initiating Abseamed in such patients.
Minor Interactions
Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) have been associated with reduced erythropoietin response in some patients. The mechanism may involve suppression of endogenous erythropoietin production or interference with iron metabolism. Patients on ACE inhibitors who show a suboptimal response to Abseamed may require higher doses or alternative management strategies.
Other medications that may affect the response to Abseamed include nonsteroidal anti-inflammatory drugs (NSAIDs), which can contribute to gastrointestinal blood loss and worsen anemia, and aluminum-containing phosphate binders, which may impair iron absorption and reduce the effectiveness of erythropoietin therapy.
What Is the Correct Dosage of Abseamed?
Quick Answer: The dosage of Abseamed is individualized based on the patient's condition, hemoglobin level, and response to treatment. For chronic kidney disease, the typical starting dose is 50 IU/kg three times per week. The dose is adjusted to maintain hemoglobin between 10-12 g/dL. Treatment must always be supervised by a qualified healthcare provider.
Abseamed dosing is highly individualized and depends on the clinical indication, the patient's current hemoglobin level, the desired hemoglobin target, the rate of hemoglobin rise, and individual response to therapy. All dosing decisions should be made by a physician experienced in the management of anemia with erythropoiesis-stimulating agents. The following guidelines represent typical dosing recommendations based on the approved prescribing information and international clinical guidelines.
Adults with Chronic Kidney Disease
Hemodialysis Patients
Starting dose: 50 IU/kg three times per week, administered intravenously.
Dose adjustment: Increase or decrease by approximately 25 IU/kg three times per week if the hemoglobin increase is less than 1 g/dL over 4 weeks or if the hemoglobin exceeds target levels. The rate of hemoglobin rise should not exceed 2 g/dL per month.
Maintenance dose: Typically 75-300 IU/kg per week, divided into 2-3 doses. Some patients may require doses outside this range.
Target hemoglobin: 10-12 g/dL (do not exceed 12 g/dL).
Pre-dialysis Patients
Starting dose: 50 IU/kg three times per week, administered subcutaneously.
Dose adjustment: Increase by 25 IU/kg three times per week at 4-week intervals until the target hemoglobin is achieved. Reduce dose by 25% if hemoglobin rises above 12 g/dL or increases by more than 2 g/dL in 4 weeks.
Maintenance dose: Typically lower than hemodialysis patients; once-weekly or twice-weekly administration may be sufficient.
Children (1-18 years) on Hemodialysis
Pediatric Dosing
Starting dose: 50 IU/kg three times per week, administered intravenously.
Dose adjustment: Same principles as adults. Increase by 25 IU/kg three times per week at 4-week intervals if needed.
Maintenance dose: Typically 75-300 IU/kg per week. Children, especially those under 5 years, often require higher doses per kilogram of body weight than adults.
Note: Pediatric dosing for pre-dialysis CKD has not been established in clinical trials.
Cancer Patients on Chemotherapy
Chemotherapy-Induced Anemia
Starting dose: 150 IU/kg three times per week, administered subcutaneously. Alternatively, 450 IU/kg once weekly.
Dose escalation: If the hemoglobin increase is less than 1 g/dL after 4 weeks, the dose may be increased to 300 IU/kg three times per week.
Discontinuation: If there is no adequate response after 4 weeks at the higher dose, treatment should be discontinued. Treatment should also be stopped approximately 4 weeks after the end of chemotherapy.
Target hemoglobin: The lowest hemoglobin concentration that avoids the need for blood transfusions; do not exceed 12 g/dL.
Surgical Setting
Reduction of Blood Transfusions
Dose: 600 IU/kg administered subcutaneously on days 21, 14, and 7 before surgery and on the day of surgery. Alternatively, 300 IU/kg daily for 15 days (10 days before surgery, on the day of surgery, and for 4 days afterward).
Iron supplementation: All surgical patients should receive adequate iron supplementation throughout the treatment period.
Thrombosis prevention: Adequate antithrombotic measures must be taken in all surgical patients receiving erythropoietin.
Missed Dose
If you miss a scheduled dose of Abseamed, contact your healthcare provider for instructions. Do not take a double dose to make up for a missed one. The next dose should be administered as soon as possible according to your regular dosing schedule. If you are unsure about what to do, seek advice from your doctor, pharmacist, or nurse. Regular adherence to the prescribed dosing schedule is important for maintaining stable hemoglobin levels and achieving optimal treatment outcomes.
Overdose
The therapeutic margin of erythropoietin products is wide. However, overdose can lead to polycythemia (excessively high red blood cell count), which significantly increases the risk of thromboembolic complications such as deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. Severe hypertension may also develop. If polycythemia occurs, Abseamed should be temporarily withheld and the patient should receive appropriate supportive care, which may include phlebotomy (blood removal) to reduce the hematocrit. Monitoring of vital signs, blood pressure, and blood counts is essential following an overdose.
Abseamed should only be used under the supervision of a healthcare professional experienced in managing anemia with erythropoiesis-stimulating agents. Self-injection at home is possible after adequate training, but dosage adjustments must always be made by your doctor based on regular blood test results.
What Are the Side Effects of Abseamed?
Quick Answer: The most common side effects of Abseamed include hypertension (high blood pressure), headache, joint pain, and flu-like symptoms. Serious but less common side effects include blood clots (thromboembolism), pure red cell aplasia, and severe skin reactions. Contact your healthcare provider immediately if you experience sudden swelling, difficulty breathing, or severe headache.
Like all medicines, Abseamed can cause side effects, although not everybody gets them. The side effects of erythropoietin therapy are well characterized through decades of clinical experience with the reference product and biosimilars. The frequency and severity of side effects can vary depending on the underlying condition being treated, the dose used, and individual patient factors.
The side effect profile may differ between patient populations. Patients with chronic kidney disease on dialysis have a different risk profile compared to cancer patients receiving chemotherapy or surgical patients. Your healthcare provider will discuss the specific risks relevant to your situation before starting treatment.
Very Common (affects more than 1 in 10 people)
Reported in >10% of patients
- Headache (particularly at the start of treatment)
- Hypertension (high blood pressure) or worsening of existing hypertension
- Flu-like symptoms (fever, chills, myalgia) especially with initial doses
- Upper respiratory tract infections (in CKD patients)
- Nausea (particularly in cancer patients)
Common (affects 1 in 10 to 1 in 100 people)
Reported in 1-10% of patients
- Arthralgia (joint pain)
- Injection site reactions (pain, redness, swelling at the injection site)
- Diarrhea
- Vomiting
- Pyrexia (fever)
- Cough
- Rash and skin irritation
- Thromboembolic events (blood clots including deep vein thrombosis)
- Hypertensive crisis (sudden severe increase in blood pressure)
- Seizures (particularly in CKD patients)
Uncommon (affects 1 in 100 to 1 in 1,000 people)
Reported in 0.1-1% of patients
- Hyperkalemia (elevated potassium levels)
- Pulmonary embolism
- Myocardial infarction (heart attack)
- Cerebrovascular accident (stroke)
- Thrombosis of arteriovenous fistula (in hemodialysis patients)
- Hypersensitivity reactions (allergic reactions)
Rare (affects less than 1 in 1,000 people)
Reported in <0.1% of patients
- Pure red cell aplasia (PRCA) – the body stops producing red blood cells due to anti-erythropoietin antibodies
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Anaphylactic reactions
- Angioedema
- Porphyria exacerbation
- Sudden severe headache, confusion, visual disturbances, or seizures (may indicate hypertensive encephalopathy)
- Chest pain, shortness of breath, or sudden leg swelling (may indicate thromboembolism)
- Sudden weakness or numbness on one side of the body, difficulty speaking (may indicate stroke)
- Severe skin rash with blistering or peeling
- Signs of severe allergic reaction: swelling of face, lips, tongue, or throat; difficulty breathing; rapid heartbeat
Most side effects of Abseamed are manageable with appropriate monitoring and dose adjustments. The risk of side effects can be minimized by adhering to recommended hemoglobin targets, monitoring blood pressure regularly, and ensuring adequate iron supplementation. Your healthcare provider will weigh the benefits of treatment against the potential risks for your individual situation.
How Should You Store Abseamed?
Quick Answer: Store Abseamed in a refrigerator at 2-8°C. Do not freeze. Keep the pre-filled syringes in the outer carton to protect from light. Abseamed may be removed from the refrigerator and stored at room temperature (up to 25°C) for a single period of up to 3 days.
Proper storage of Abseamed is critical to maintaining its potency and safety. As a biological medicine containing a protein (epoetin alfa), it is sensitive to temperature extremes, light exposure, and physical agitation. Improper storage can lead to protein degradation, loss of efficacy, or the formation of aggregates that may increase the risk of adverse reactions.
- Refrigerate at 2-8°C (36-46°F): Store the pre-filled syringes in the refrigerator at all times when not in use. Place them in the main body of the refrigerator, not in the door or near the freezer compartment, where temperature fluctuations are more likely.
- Do not freeze: Freezing irreversibly damages the protein structure of epoetin alfa and renders the medicine ineffective. If a syringe has been accidentally frozen, it must not be used and should be disposed of safely.
- Protect from light: Keep the pre-filled syringes in their original outer carton to protect them from light exposure, which can degrade the active substance over time.
- Do not shake: Avoid vigorous shaking of the pre-filled syringes, as this can cause protein aggregation and denaturation. Gentle handling is important.
- Temporary room temperature storage: If needed (e.g., for travel or convenience), Abseamed may be removed from the refrigerator and stored at room temperature (not above 25°C/77°F) for a single period of up to 3 days. Once removed from the refrigerator, the syringe should not be returned to refrigerated storage and must be used within the 3-day period or discarded.
- Keep out of reach of children: Store in a safe location inaccessible to children.
- Check expiry date: Do not use Abseamed after the expiry date stated on the label and outer carton. The expiry date refers to the last day of that month.
- Visual inspection: Before use, visually inspect the solution. It should be clear and colorless. Do not use if the solution appears cloudy, discolored, or contains visible particles.
Dispose of unused or expired Abseamed according to your local regulations. Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer use. Pre-filled syringes should be placed in a sharps disposal container after use.
What Does Abseamed Contain?
Quick Answer: Each pre-filled syringe of Abseamed contains 10,000 IU (83.4 micrograms) of epoetin alfa as the active substance. Inactive ingredients include sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, and water for injections.
Active Ingredient
The active substance in Abseamed is epoetin alfa, a 165-amino acid glycoprotein produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Epoetin alfa is structurally identical to the naturally occurring human erythropoietin hormone, including its glycosylation pattern, which is essential for biological activity and a longer circulating half-life in the body.
Each pre-filled syringe contains 10,000 international units (IU) of epoetin alfa, equivalent to approximately 83.4 micrograms of protein, in 1 mL of solution.
Inactive Ingredients (Excipients)
- Sodium dihydrogen phosphate dihydrate: Buffer component that helps maintain the pH of the solution within an optimal range for stability and biocompatibility.
- Disodium phosphate dihydrate: Buffer component that works together with sodium dihydrogen phosphate to maintain pH stability.
- Sodium chloride: Used to adjust the tonicity (osmolarity) of the solution to match physiological conditions, ensuring the injection is comfortable and safe.
- Polysorbate 80: A nonionic surfactant that helps stabilize the protein and prevents aggregation and adsorption to the syringe surfaces.
- Water for injections: The solvent used to dissolve all components into a clear, injectable solution.
Abseamed does not contain human serum albumin as a stabilizer, which differentiates it from some older epoetin alfa formulations. The polysorbate 80-based formulation has been shown to maintain stability and efficacy comparable to albumin-containing formulations.
Abseamed contains less than 1 mmol sodium (23 mg) per dose, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet, particularly those with chronic kidney disease or heart failure.
Frequently Asked Questions About Abseamed
Medical References & Sources
All medical information in this article is based on peer-reviewed scientific research and official product information from regulatory agencies. Sources include:
- European Medicines Agency (EMA). Abseamed – Summary of Product Characteristics (SmPC). EMA/H/C/000727. Available at: EMA – Abseamed
- KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney International Supplements. 2012;2(4):279-335. Updated 2024.
- Bohlius J, et al. Erythropoiesis-stimulating agents for the treatment of chemotherapy-induced anaemia: a systematic review and economic evaluation. Health Technology Assessment. 2014;18(61).
- World Health Organization. WHO Model List of Essential Medicines – 23rd Edition (2023). Geneva: WHO; 2023. Erythropoietin listed as essential for anemia management.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Management of Anaemia and Iron Deficiency in Patients with Cancer. Annals of Oncology. 2018;29(Supplement 4):iv96-iv110.
- Drüeke TB, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. New England Journal of Medicine. 2006;355(20):2071-2084.
- Singh AK, et al. Correction of anemia with epoetin alfa in chronic kidney disease. New England Journal of Medicine. 2006;355(20):2085-2098. (CHOIR trial)
- Pfeffer MA, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. New England Journal of Medicine. 2009;361(21):2019-2032. (TREAT trial)
- Weise M, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111-5117.
- British National Formulary (BNF). Epoetin alfa – monograph. National Institute for Health and Care Excellence. 2026 edition.
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