Darboren
Generic Name
Darboren-40 mcg Injection (Darbepoetin alfa)
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| darboren 40 mcg injection | ৳ 4,500.00 | N/A |
Description
Overview of the medicine
Darboren 40 mcg Injection contains Darbepoetin alfa, a long-acting erythropoiesis-stimulating protein. It is used to treat anemia associated with chronic kidney disease (CKD) and chemotherapy in cancer patients.
Uses & Indications
Dosage
Adults
For CKD: Initial dose 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every two weeks. For chemotherapy-induced anemia: Initial dose 2.25 mcg/kg SC once weekly, or 500 mcg SC once every three weeks.
Elderly
No specific dose adjustment is generally required, but close monitoring is recommended.
Renal_impairment
Primary indication; dosage adjusted based on hemoglobin response and target levels. Iron supplementation is often required.
How to Take
Administer by subcutaneous (SC) or intravenous (IV) injection. Do not shake the syringe. Use only clear, colorless solution.
Mechanism of Action
Darbepoetin alfa stimulates erythropoiesis by acting like endogenous erythropoietin. It binds to erythropoietin receptors on progenitor cells in the bone marrow, promoting the proliferation and differentiation of erythroid precursor cells into mature red blood cells.
Pharmacokinetics
Onset
Gradual; effects on hemoglobin levels are typically observed within 2 to 6 weeks.
Excretion
Mainly through non-renal catabolism, with minimal excretion via urine.
Half life
Approximately 21 hours after intravenous (IV) administration and 49 hours after subcutaneous (SC) administration in CKD patients.
Absorption
Following subcutaneous (SC) administration, absorption is slow and prolonged. Bioavailability is approximately 37% (IV) to 80% (SC).
Metabolism
Primarily cleared through catabolism; minimal renal excretion.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) occurring after treatment with any erythropoietin protein.
- Serious allergic reactions to darbepoetin alfa.
Drug Interactions
Iron supplements
May be needed to ensure an adequate supply of iron for erythropoiesis, especially when starting treatment.
No formal studies
No formal drug interaction studies have been conducted.
Storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia, requiring phlebotomy. Management should be supportive, aiming to maintain hemoglobin levels within the target range.
Pregnancy & Lactation
Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether darbepoetin alfa is excreted in human milk; use with caution during lactation.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) occurring after treatment with any erythropoietin protein.
- Serious allergic reactions to darbepoetin alfa.
Drug Interactions
Iron supplements
May be needed to ensure an adequate supply of iron for erythropoiesis, especially when starting treatment.
No formal studies
No formal drug interaction studies have been conducted.
Storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia, requiring phlebotomy. Management should be supportive, aiming to maintain hemoglobin levels within the target range.
Pregnancy & Lactation
Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether darbepoetin alfa is excreted in human milk; use with caution during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
As indicated on the packaging, typically 24-36 months from manufacture.
Availability
Available in hospitals and pharmacies
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Original compound patent protected, generics available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of darbepoetin alfa in treating anemia in CKD and chemotherapy patients.
Lab Monitoring
- Hemoglobin and Hematocrit levels (at least weekly until stable, then monthly).
- Iron status (serum ferritin, transferrin saturation) before and during treatment.
- Blood pressure monitoring regularly.
Doctor Notes
- Aim for the lowest hemoglobin level sufficient to avoid blood transfusions, generally not exceeding 11 g/dL for CKD patients.
- Assess iron status before and during treatment; iron supplementation is critical for optimal response.
- Educate patients on potential cardiovascular risks and symptoms of blood clots.
Patient Guidelines
- Do not shake the pre-filled syringe.
- Report any unusual symptoms, especially severe headache, vision changes, or signs of blood clots.
- Maintain adequate iron levels as advised by your doctor.
- Follow your doctor's instructions regarding dose and administration schedule.
Missed Dose Advice
If a dose is missed, administer it as soon as remembered. Then, resume the regular dosing schedule. Do not administer a double dose.
Driving Precautions
Darbepoetin alfa may increase the risk of seizures. Patients should exercise caution when driving or operating machinery, especially during the initial phase of treatment.
Lifestyle Advice
- Maintain a healthy diet.
- Avoid smoking.
- Manage underlying conditions like hypertension.
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