Usage
- Medical Conditions: Recombinant human erythropoietin beta (rhEPO-beta) is primarily prescribed for the treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis and in patients not yet on dialysis. It is also used to treat anemia in patients with non-myeloid malignancies undergoing chemotherapy, increase the yield of autologous blood from patients in a pre-donation program, and prevent anemia of prematurity in infants with a birth weight of 750g to 1500g and a gestational age of less than 34 weeks. Additionally, rhEPO-beta is used in the treatment of symptomatic anemia in patients with multiple myeloma, low-grade non-Hodgkin’s lymphoma, or chronic lymphocytic leukemia with a relative erythropoietin deficiency.
- Pharmacological Classification: Erythropoiesis-stimulating agent (ESA), antianemic agent.
- Mechanism of Action: rhEPO-beta stimulates erythropoiesis by mimicking the action of endogenous erythropoietin. It binds to erythropoietin receptors on erythroid progenitor cells in the bone marrow, promoting their proliferation, differentiation, and maturation into red blood cells. This leads to an increase in hemoglobin levels and red blood cell counts.
Alternate Names
- rhEPO, epoetin beta, recombinant human erythropoietin.
- Brand Names: NeoRecormon, Recormon, Epogin.
How It Works
- Pharmacodynamics: rhEPO-beta stimulates erythropoiesis, leading to increased red blood cell production and hemoglobin levels. This improves oxygen delivery to tissues, alleviating symptoms of anemia such as fatigue and shortness of breath.
- Pharmacokinetics:
- Absorption: Slowly and incompletely absorbed after subcutaneous administration. Absorption is more rapid and complete following intravenous administration.
- Metabolism: Limited information is available regarding the metabolism of rhEPO-beta.
- Elimination: The elimination pathway is not fully characterized, but both renal and hepatic routes are likely involved. The terminal half-life after subcutaneous administration is approximately 24 hours.
- Mode of Action: Binds to erythropoietin receptors on erythroid progenitor cells in the bone marrow. This binding activates intracellular signaling pathways that promote cell survival, proliferation, and differentiation.
- Receptor Binding: Binds to erythropoietin receptors.
- Elimination Pathways: Renal and hepatic.
Dosage
Standard Dosage
Adults:
- Chronic Kidney Disease: Initial dose: 30,000 IU weekly (approximately 450 IU/kg/week) subcutaneously as a single injection or in 3-7 divided doses; intravenous administration: 40 IU/kg three times per week. Adjust dose based on hemoglobin response. Maintenance dose: Titrate to maintain target hemoglobin (generally 10-12 g/dL). Maximum: 60,000 IU/week or 720 IU/kg/week.
- Chemotherapy-Induced Anemia: Initial dose: 30,000 IU weekly subcutaneously or in 3-7 divided doses. Maintenance: Adjust to maintain hemoglobin levels and reduce transfusion needs. Maximum: 60,000 IU/week (up to 900 IU/kg/week in some guidelines).
- Autologous Blood Donation: 200-800 IU/kg intravenously twice weekly or 150-600 IU/kg subcutaneously twice weekly for 4 weeks.
Children:
- Chronic Kidney Disease: Initial dose: 50 units/kg three times a week IV or SC. Adjust based on hemoglobin response.
- Anemia of Prematurity: 250 IU/kg three times a week subcutaneously for 6 weeks, starting within 3 days of birth.
Special Cases:
- Elderly Patients: No specific dose adjustment is recommended, but careful monitoring is necessary.
- Patients with Renal Impairment: Dose adjustments may be required based on hemoglobin response.
- Patients with Hepatic Dysfunction: No specific dose adjustment is recommended, but careful monitoring is necessary.
- Patients with Comorbid Conditions: Individualized dosing based on the specific comorbid condition and patient response.
Dosage Adjustments
Adjust dose based on hemoglobin response and individual patient characteristics. Dose modifications are often necessary in patients with renal impairment, hepatic dysfunction, or other comorbid conditions.
Side Effects
Common Side Effects
- Hypertension
- Headache
- Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism)
- Injection site reactions (e.g., pain, redness, swelling)
- Flu-like symptoms (e.g., fever, chills, body aches)
Rare but Serious Side Effects
- Pure red cell aplasia
- Seizures
- Stroke
- Myocardial infarction
Long-Term Effects
- Increased risk of cardiovascular events with prolonged use and high hemoglobin targets.
Adverse Drug Reactions (ADR)
- Antibody formation against rhEPO-beta, leading to pure red cell aplasia.
Contraindications
- Hypersensitivity to epoetin beta or any component of the formulation.
- Uncontrolled hypertension.
Drug Interactions
- ACE inhibitors and other antihypertensive medications: May require dose adjustments to control blood pressure.
- Iron supplements: Concomitant iron supplementation is often necessary for optimal response.
- CYP450 interactions: Limited information is available on CYP450 interactions.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: C (limited data available).
- Fetal Risks: Potential risk of fetal harm is unknown.
- Breastfeeding: It is unknown if rhEPO-beta is excreted in breast milk. Use with caution in breastfeeding mothers.
Drug Profile Summary
- Mechanism of Action: Stimulates erythropoiesis by binding to erythropoietin receptors.
- Side Effects: Hypertension, thromboembolic events, injection site reactions, pure red cell aplasia (rare).
- Contraindications: Hypersensitivity to epoetin beta, uncontrolled hypertension.
- Drug Interactions: Antihypertensive medications, iron supplements.
- Pregnancy & Breastfeeding: Use with caution.
- Dosage: Varies depending on indication and patient characteristics.
- Monitoring Parameters: Hemoglobin, blood pressure, iron status, transferrin saturation.
Popular Combinations
- Iron supplements: Often prescribed with rhEPO-beta to ensure adequate iron stores for erythropoiesis.
Precautions
- General Precautions: Monitor hemoglobin, blood pressure, and iron status closely. Correct iron deficiency before and during treatment.
- Specific Populations: Monitor patients with CKD, pregnant or breastfeeding women, children, and the elderly carefully.
- Lifestyle Considerations: No specific lifestyle considerations are associated with rhEPO-beta use.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Recombinant Human Erythropoietin Beta?
A: Dosage varies depending on the indication and patient-specific factors. Refer to the Dosage section for detailed information.
Q2: What are the common side effects of Recombinant Human Erythropoietin Beta?
A: Common side effects include hypertension, headache, and thromboembolic events.
Q3: How does Recombinant Human Erythropoietin Beta work?
A: It stimulates red blood cell production by binding to erythropoietin receptors in the bone marrow.
Q4: What are the contraindications for Recombinant Human Erythropoietin Beta?
A: Contraindications include hypersensitivity to the drug and uncontrolled hypertension.
Q5: Can Recombinant Human Erythropoietin Beta be used during pregnancy?
A: It should be used with caution during pregnancy and only if the potential benefit outweighs the potential risk to the fetus.
Q6: What monitoring parameters are important during treatment with rhEPO-beta?
A: Monitor hemoglobin, blood pressure, iron status (ferritin, transferrin saturation) regularly.
Q7: How is rhEPO-beta administered?
A: It can be administered either intravenously or subcutaneously.
Q8: Is rhEPO-beta compatible with iron supplements?
A: Yes, concurrent iron supplementation is often necessary for optimal response.
Q9: What should I do if a patient experiences a severe adverse reaction to rhEPO-beta?
A: Discontinue the drug immediately and provide appropriate supportive care.
Q10: How long should rhEPO-beta treatment continue?
A: The duration of treatment depends on the underlying cause of anemia and the patient’s response to therapy.
