Darbetin
Generic Name
Darbepoetin Alfa
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
darbetin 25 mcg injection | ৳ 2,840.71 | N/A |
Description
Overview of the medicine
Darbepoetin alfa is a long-acting erythropoiesis-stimulating protein that is used to treat anemia associated with chronic kidney disease or chemotherapy. It works by stimulating the bone marrow to produce red blood cells.
Uses & Indications
Dosage
Adults
For CKD: Initial dose 0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV once every two weeks. For chemotherapy-induced anemia: Initial dose 2.25 mcg/kg SC weekly or 500 mcg SC every 3 weeks.
Elderly
No specific dose adjustment required for elderly patients, but caution is advised due to increased susceptibility to cardiovascular events.
Renal_impairment
Primary indication for use in patients with renal impairment (CKD); dosage is adjusted based on hemoglobin levels.
How to Take
Administer by subcutaneous (SC) or intravenous (IV) injection. Do not shake the syringe. Use immediately after withdrawal from refrigeration. Do not mix with other medications.
Mechanism of Action
Darbepoetin alfa stimulates erythropoiesis by binding to erythropoietin receptors on erythroid progenitor cells in the bone marrow, promoting their proliferation and differentiation into mature red blood cells.
Pharmacokinetics
Onset
Erythroid response is typically observed within 2-6 weeks of initiation of therapy.
Excretion
Mainly cleared by the reticuloendothelial system; minimal renal excretion of intact drug.
Half life
Approximately 49 hours for subcutaneous administration and 21 hours for intravenous administration.
Absorption
Subcutaneous (SC) absorption is slow and sustained, reaching peak concentrations in 24-72 hours. Intravenous (IV) administration results in immediate bioavailability.
Metabolism
The metabolic pathway of darbepoetin alfa is not fully characterized, but it is likely cleared through catabolism rather than hepatic metabolism.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure Red Cell Aplasia (PRCA) unrelated to darbepoetin alfa therapy.
- Known hypersensitivity to darbepoetin alfa, any excipients, or mammalian-derived products.
Drug Interactions
No specific drug interactions have been identified for darbepoetin alfa.
Darbepoetin alfa is not metabolized by cytochrome P450 enzymes.
Storage
Store in a refrigerator (2°C-8°C). Do not freeze. Protect from light. Do not shake.
Overdose
Overdosage can lead to signs of polycythemia (excessive red blood cells). Management typically involves phlebotomy to reduce hemoglobin levels.
Pregnancy & Lactation
Pregnancy Category C. Use only if 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 woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, refer to the product leaflet for exact expiry date.
Availability
Hospitals and pharmacies
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patents expired, generic versions available
Clinical Trials
Extensive clinical trials have evaluated darbepoetin alfa's efficacy and safety in various populations with anemia, including those with CKD and chemotherapy-induced anemia. Ongoing studies investigate its use in other conditions.
Lab Monitoring
- Hemoglobin (Hb) levels (monitor weekly or bi-weekly until stable, then monthly)
- Hematocrit
- Blood pressure (monitor regularly)
- Serum ferritin and transferrin saturation (TSAT) to assess iron status
Doctor Notes
- Monitor hemoglobin levels closely and adjust dose to maintain levels within the target range (e.g., 10-11 g/dL). Avoid exceeding 11 g/dL.
- Monitor blood pressure and manage hypertension effectively.
- Assess iron status before and during treatment; iron supplementation may be required.
Patient Guidelines
- Do not shake the syringe vigorously as this may denature the protein.
- Store in the refrigerator (2°C-8°C) in the original carton to protect from light. Do not freeze.
- Follow your doctor's instructions regarding dose and administration schedule.
- Report any new or worsening symptoms, especially high blood pressure or signs of blood clots.
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 is not expected to affect the ability to drive or use machinery. However, patients should be aware of potential side effects like headache or seizures, and should avoid driving or operating machinery if these occur.
Lifestyle Advice
- Maintain a healthy diet, particularly one rich in iron if advised by your doctor.
- Regularly monitor blood pressure as advised by your healthcare provider.
- Engage in light physical activity as tolerated.
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Global Brand Names
International brand names for this medicine
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