gbpoietin
Generic Name
gbpoietin-5000-iu-injection
Manufacturer
Acme Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| gbpoietin 5000 iu injection | ৳ 2,990.19 | N/A |
Description
Overview of the medicine
Epoetin alfa is a recombinant human erythropoietin, used to treat anemia by stimulating red blood cell production. It is a glycoprotein that acts like the natural hormone erythropoietin produced by the kidneys.
Uses & Indications
Dosage
Adults
Dosage varies based on indication, route, and patient response. For CKD, typically 50-100 IU/kg three times weekly (IV or SC), adjusted to maintain target hemoglobin levels (10-11 g/dL). For cancer chemotherapy, 150-300 IU/kg once weekly or 40,000-60,000 IU once weekly (SC).
Elderly
Similar to adult dosage, but close monitoring required due to potential comorbidities and increased sensitivity.
Renal_impairment
Specific dosage guidelines for CKD patients are provided; no additional adjustment beyond these standard CKD dosing recommendations.
How to Take
gbpoietin can be administered either intravenously (IV) or subcutaneously (SC). The route of administration depends on the patient's condition and the indication. Do not shake the vial/syringe vigorously. Administer slowly.
Mechanism of Action
Epoetin alfa stimulates erythropoiesis by binding to erythropoietin receptors on erythroid progenitor cells in the bone marrow, leading to red blood cell proliferation and differentiation, ultimately increasing red blood cell mass.
Pharmacokinetics
Onset
Significant increase in reticulocytes within 10 days, with a rise in hemoglobin levels typically seen in 2-6 weeks.
Excretion
Only a small fraction is excreted renally; larger molecules like epoetin are usually catabolized.
Half life
IV: 4-13 hours. SC: 13-24 hours.
Absorption
Subcutaneous absorption is slow and incomplete (bioavailability 30-40%). Intravenous administration results in rapid distribution.
Metabolism
Primarily degraded by receptor-mediated endocytosis in erythroid progenitor cells; partially metabolized in the liver.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Known hypersensitivity to mammalian cell-derived products or any component of the formulation.
- Pure red cell aplasia (PRCA) developed after treatment with any erythropoietin protein.
- Patients with serious cardiovascular events, including stroke or myocardial infarction, within the last month (for perioperative use).
Drug Interactions
Ciclosporin
Epoetin may increase ciclosporin blood levels, requiring close monitoring and potential dosage adjustment of ciclosporin.
Iron supplements
Often needed concurrently, as iron stores may become depleted due to increased erythropoiesis. Monitor iron status and supplement as needed.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia (excessive red blood cells) with associated complications like increased blood viscosity, thrombotic events, and hypertension. Management involves phlebotomy to reduce hematocrit and symptomatic supportive care.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if clearly needed and potential benefits outweigh risks. Caution advised during lactation as it is unknown if epoetin is excreted in human milk; weigh benefits against potential risks to the infant.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Known hypersensitivity to mammalian cell-derived products or any component of the formulation.
- Pure red cell aplasia (PRCA) developed after treatment with any erythropoietin protein.
- Patients with serious cardiovascular events, including stroke or myocardial infarction, within the last month (for perioperative use).
Drug Interactions
Ciclosporin
Epoetin may increase ciclosporin blood levels, requiring close monitoring and potential dosage adjustment of ciclosporin.
Iron supplements
Often needed concurrently, as iron stores may become depleted due to increased erythropoiesis. Monitor iron status and supplement as needed.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia (excessive red blood cells) with associated complications like increased blood viscosity, thrombotic events, and hypertension. Management involves phlebotomy to reduce hematocrit and symptomatic supportive care.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if clearly needed and potential benefits outweigh risks. Caution advised during lactation as it is unknown if epoetin is excreted in human milk; weigh benefits against potential risks to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 24 to 36 months when stored under recommended conditions.
Availability
Hospitals, Clinics, Pharmacies
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patent expired for original compound, biosimilars available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of epoetin alfa in treating anemia across various indications, leading to its widespread approval and use globally. Post-marketing surveillance continues to monitor safety.
Lab Monitoring
- Hemoglobin levels (weekly initially, then every 2-4 weeks) until stable, then regularly.
- Hematocrit.
- Iron status (serum ferritin, transferrin saturation) before and during treatment.
- Blood pressure monitoring regularly.
Doctor Notes
- Monitor hemoglobin levels closely, typically targeting 10-11 g/dL, to minimize cardiovascular risks. Avoid exceeding 11 g/dL.
- Assess iron stores (ferritin, TSAT) before and throughout treatment; iron supplementation is crucial for optimal response.
- Closely monitor blood pressure; manage hypertension aggressively. Consider dose reduction or discontinuation if hypertension is difficult to control.
- Educate patients on symptoms of thrombotic events and PRCA; instruct them to seek immediate medical attention if symptoms occur.
Patient Guidelines
- Do not shake the vial or pre-filled syringe.
- Store in the refrigerator (2-8°C) and protect from light. Do not freeze.
- Report any signs of blood clot (e.g., chest pain, difficulty breathing, swelling/pain in leg) or severe allergic reaction immediately.
- Adhere strictly to the prescribed dosage and schedule; do not adjust dose without consulting your doctor.
Missed Dose Advice
If a dose is missed, administer it as soon as remembered, unless it is almost time for the next scheduled dose. Do not double the dose to make up for a missed one. Contact your healthcare provider for further guidance.
Driving Precautions
gbpoietin is not known to directly impair the ability to drive or operate machinery. However, if you experience side effects such as seizures or severe headache, avoid such activities until symptoms resolve.
Lifestyle Advice
- Maintain a healthy diet, particularly rich in iron, folic acid, and Vitamin B12, to support erythropoiesis.
- Monitor blood pressure regularly at home as directed by your doctor.
- Avoid smoking, as it can increase the risk of cardiovascular complications.
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