Darbetin
Generic Name
Darbepoetin alfa
Manufacturer
Drug International Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| darbetin 40 mcg injection | ৳ 4,545.15 | N/A |
Description
Overview of the medicine
Darbepoetin alfa is a long-acting erythropoiesis-stimulating agent (ESA) that stimulates the production of red blood cells. It is used to treat anemia in patients with chronic kidney disease (CKD), both on dialysis and not on dialysis, and in patients with myelosuppressive chemotherapy-induced anemia.
Uses & Indications
Dosage
Adults
For CKD-associated anemia: Initial dose 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC every 2 weeks. For chemotherapy-induced anemia: Initial dose 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks. Adjust dose to maintain target hemoglobin levels (e.g., 10-12 g/dL).
Elderly
No specific dosage adjustment is generally required, but monitor for adverse reactions due to potential decreased renal function.
Renal_impairment
Dosage is specific to the stage and dialysis status of chronic kidney disease. Follow standard guidelines for CKD patients, adjusting to maintain target hemoglobin levels.
How to Take
Administer subcutaneously or intravenously. Ensure proper technique if self-administering after training. Do not shake. Inspect visually for particulate matter and discoloration prior to administration.
Mechanism of Action
Darbepoetin alfa stimulates erythropoiesis by binding to and activating erythropoietin receptors on the surface of erythroid progenitor cells, leading to increased red blood cell production. It is a hyperglycosylated analog of recombinant human erythropoietin, giving it a longer half-life.
Pharmacokinetics
Onset
Reticulocyte count increases within 7-10 days. Hemoglobin levels typically begin to rise within 2-6 weeks.
Excretion
Minor renal excretion of intact drug. Primarily cleared via non-renal pathways.
Half life
Approximately 21 hours (intravenous) and 49 hours (subcutaneous).
Absorption
Slowly absorbed after subcutaneous administration, with bioavailability approximately 37% (range 30-50%). Peak plasma concentrations are reached 48-72 hours post-dose.
Metabolism
Primarily metabolized by the reticuloendothelial system. Degraded into amino acids.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Known serious hypersensitivity to Darbepoetin alfa or any component of the formulation.
- Pure Red Cell Aplasia (PRCA) that began after treatment with Darbepoetin alfa or other erythropoietin protein drugs.
Drug Interactions
Other ESAs
Concomitant use with other erythropoiesis-stimulating agents is not recommended due to additive effects and potential for overdose.
Iron supplements
Iron supplementation is almost always required to support erythropoiesis, especially when starting Darbepoetin alfa. Inadequate iron stores can limit the response to Darbepoetin alfa.
Storage
Store in a refrigerator (2°C to 8°C / 36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to symptoms of polycythemia (excessive red blood cells) which may manifest as elevated hemoglobin levels and increased blood viscosity. This can increase the risk of thrombotic events such as stroke, myocardial infarction, and pulmonary embolism. Management typically involves phlebotomy to reduce hemoglobin levels and symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Darbepoetin alfa is excreted in human milk; use with caution in nursing mothers.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Known serious hypersensitivity to Darbepoetin alfa or any component of the formulation.
- Pure Red Cell Aplasia (PRCA) that began after treatment with Darbepoetin alfa or other erythropoietin protein drugs.
Drug Interactions
Other ESAs
Concomitant use with other erythropoiesis-stimulating agents is not recommended due to additive effects and potential for overdose.
Iron supplements
Iron supplementation is almost always required to support erythropoiesis, especially when starting Darbepoetin alfa. Inadequate iron stores can limit the response to Darbepoetin alfa.
Storage
Store in a refrigerator (2°C to 8°C / 36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to symptoms of polycythemia (excessive red blood cells) which may manifest as elevated hemoglobin levels and increased blood viscosity. This can increase the risk of thrombotic events such as stroke, myocardial infarction, and pulmonary embolism. Management typically involves phlebotomy to reduce hemoglobin levels and symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Darbepoetin alfa is excreted in human milk; use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months when stored under recommended conditions.
Availability
Hospitals, retail pharmacies
Approval Status
FDA and global regulatory approvals
Patent Status
Generics available, original patent expired
Clinical Trials
Darbepoetin alfa has undergone extensive clinical trials demonstrating efficacy and safety in treating anemia associated with chronic kidney disease and chemotherapy-induced anemia. Trials have evaluated different dosing regimens and patient populations.
Lab Monitoring
- Hemoglobin and hematocrit levels (at least weekly until stable, then regularly).
- Blood pressure (regularly).
- Iron status (serum ferritin and transferrin saturation).
- Renal function (BUN, creatinine).
Doctor Notes
- Emphasize careful monitoring of hemoglobin levels; do not exceed 11 g/dL. Dosing should be individualized and adjusted to maintain hemoglobin within a target range (e.g., 10-11 g/dL).
- Strict blood pressure control is essential before and during Darbepoetin alfa therapy.
- Monitor for signs and symptoms of PRCA (sudden decrease in hemoglobin, severe anemia, increased iron saturation) and discontinue if suspected. Evaluate iron status regularly.
Patient Guidelines
- Do not shake the syringe or vial.
- Do not reuse syringes or needles.
- Store in the refrigerator, protect from light.
- Report any signs of allergic reaction or serious side effects immediately.
- Maintain a balanced diet and ensure adequate iron intake as advised by your doctor.
Missed Dose Advice
If a dose is missed, administer it as soon as it is remembered. Then, resume the usual dosing schedule. Do not administer a double dose to make up for a missed one. Contact your healthcare provider for specific advice.
Driving Precautions
Darbepoetin alfa is not known to directly impair the ability to drive or operate machinery. However, patients should be aware of potential side effects, such as seizures or dizziness, which could affect these abilities. Exercise caution until you know how the medicine affects you.
Lifestyle Advice
- Follow a heart-healthy diet as recommended by your doctor to help manage blood pressure.
- Regular physical activity as tolerated, under medical supervision.
- Avoid smoking, which can worsen cardiovascular risks.
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