Darbetin
Generic Name
Darbepoetin alfa
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| darbetin 100 mcg injection | ৳ 9,090.30 | N/A |
Description
Overview of the medicine
Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA), a synthetic form of erythropoietin. It stimulates the bone marrow to produce red blood cells and is used to treat anemia associated with chronic kidney disease (CKD) and chemotherapy in cancer patients.
Uses & Indications
Dosage
Adults
Anemia of CKD: Initial dose 0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV once every 2 weeks. Adjust dose to maintain hemoglobin levels within target range. Chemotherapy-induced anemia: Initial dose 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks.
Elderly
No specific dose adjustment recommended for elderly patients, but monitoring for adverse effects is advised.
Renal_impairment
Primary indication for CKD patients, dosage adjusted based on hemoglobin levels and patient response. Regular monitoring of hemoglobin is essential.
How to Take
Administer by subcutaneous (SC) or intravenous (IV) injection. Do not shake the vial or pre-filled syringe. Inspect visually for particulate matter and discoloration before administration.
Mechanism of Action
Darbepoetin alfa stimulates erythropoiesis by binding to erythropoietin receptors on erythroid progenitor cells in the bone marrow, leading to increased red blood cell production, hemoglobin levels, and hematocrit.
Pharmacokinetics
Onset
Erythroid responses (increase in hemoglobin) are typically observed within 2-6 weeks of initiation.
Excretion
Mainly cleared through receptor-mediated uptake and degradation, with some renal excretion.
Half life
Subcutaneous: approximately 49 hours. Intravenous: approximately 21 hours.
Absorption
Following subcutaneous administration, bioavailability is approximately 37%. Peak plasma concentrations are reached in 24-72 hours.
Metabolism
Not extensively metabolized. Primarily undergoes receptor-mediated clearance.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) unrelated to erythropoietin.
- Known hypersensitivity to Darbepoetin alfa or any component of the formulation.
Drug Interactions
No specific drug interactions have been identified with Darbepoetin alfa.
No specific drug interactions have been identified with Darbepoetin alfa.
Storage
Store in a refrigerator at 2-8°C (36-46°F). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia, which may require phlebotomy to reduce hemoglobin levels. Symptomatic and supportive care should be provided.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Darbepoetin alfa is excreted in human milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) unrelated to erythropoietin.
- Known hypersensitivity to Darbepoetin alfa or any component of the formulation.
Drug Interactions
No specific drug interactions have been identified with Darbepoetin alfa.
No specific drug interactions have been identified with Darbepoetin alfa.
Storage
Store in a refrigerator at 2-8°C (36-46°F). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia, which may require phlebotomy to reduce hemoglobin levels. Symptomatic and supportive care should be provided.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Darbepoetin alfa is excreted in human milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date when stored under recommended conditions.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Original patent expired, biosimilars available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of darbepoetin alfa in treating anemia associated with CKD and chemotherapy-induced anemia. Studies include various patient populations and dosing regimens.
Lab Monitoring
- Hemoglobin levels (weekly until stabilized, then periodically)
- Blood pressure (regularly)
- Serum ferritin and transferrin saturation (for iron status)
Doctor Notes
- Always individualize dosing to achieve and maintain hemoglobin levels within the target range (e.g., 10-11 g/dL for CKD).
- Monitor blood pressure meticulously and manage hypertension proactively.
- Assess iron status before and during treatment; iron supplementation may be necessary.
- Counsel patients on the Black Box Warning risks, especially for cardiovascular and thrombotic events.
Patient Guidelines
- Do not shake the Darbetin vial or syringe, as it may denature the protein.
- Report any signs of blood clots (e.g., chest pain, difficulty breathing, swelling/pain in leg) immediately.
- Monitor blood pressure regularly as directed by your doctor.
- Store in the refrigerator and protect from light. Do not freeze.
Missed Dose Advice
If a dose is missed, administer it as soon as remembered. Then resume the usual dosing schedule. Do not administer a double dose to make up for a missed dose.
Driving Precautions
Darbepoetin alfa may cause headache or dizziness in some patients. Patients should be cautious when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain a healthy diet, rich in iron and other essential nutrients, as advised by your healthcare provider.
- Avoid smoking as it can exacerbate cardiovascular risks.
- Engage in light to moderate physical activity as tolerated, under medical guidance.
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