Darboren
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 |
|---|---|---|
| darboren 60 mcg injection | ৳ 5,500.00 | N/A |
Description
Overview of the medicine
Darbepoetin alfa is a long-acting erythropoiesis-stimulating protein. It is used to treat anemia in patients with chronic kidney disease (CKD) and in cancer patients receiving myelosuppressive chemotherapy.
Uses & Indications
Dosage
Adults
Dosage varies by indication. For CKD, typical starting dose is 0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV every two weeks. Doses are individualized to maintain hemoglobin levels within target ranges (e.g., 10-11 g/dL).
Elderly
No specific dose adjustment is generally required, but close monitoring for adverse effects is recommended.
Renal_impairment
Primary indication for Darbepoetin alfa. Doses are adjusted based on individual response and target hemoglobin levels.
How to Take
Administered by subcutaneous (SC) or intravenous (IV) injection.
Mechanism of Action
Stimulates erythropoiesis by binding to the erythropoietin receptor on erythroid progenitor cells, leading to increased red blood cell production.
Pharmacokinetics
Onset
Hemoglobin increase typically observed within 2-6 weeks.
Excretion
Small amounts excreted unchanged in urine.
Half life
Approximately 25 hours (intravenous) to 49 hours (subcutaneous).
Absorption
Subcutaneous absorption is slow and sustained, with bioavailability ranging from 30-70%.
Metabolism
Primarily cleared by the reticuloendothelial system.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) unrelated to Darbepoetin alfa therapy.
- Serious allergic reactions to darbepoetin alfa or any of its excipients.
Drug Interactions
No significant direct drug interactions
No specific drug interactions have been widely reported with darbepoetin alfa. However, concomitant medications should always be reviewed.
Storage
Store refrigerated (2-8°C). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia. Management involves symptomatic and supportive treatment. Phlebotomy may be considered if polycythemia is severe.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit outweighs the potential risk to the fetus. It is unknown whether darbepoetin alfa is excreted in human milk, use with caution in nursing mothers.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) unrelated to Darbepoetin alfa therapy.
- Serious allergic reactions to darbepoetin alfa or any of its excipients.
Drug Interactions
No significant direct drug interactions
No specific drug interactions have been widely reported with darbepoetin alfa. However, concomitant medications should always be reviewed.
Storage
Store refrigerated (2-8°C). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia. Management involves symptomatic and supportive treatment. Phlebotomy may be considered if polycythemia is severe.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit outweighs the potential risk to the fetus. It is unknown 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 2-3 years, depending on manufacturing date and storage conditions.
Availability
Hospitals, Clinics, Specialty pharmacies
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Off-patent for active ingredient, brand-specific patents may vary
Clinical Trials
Numerous clinical trials have established the efficacy and safety of darbepoetin alfa for its approved indications. Ongoing trials may explore new indications or patient populations.
Lab Monitoring
- Hemoglobin and hematocrit levels
- Iron status (ferritin, transferrin saturation)
- Blood pressure
- Renal function
Doctor Notes
- Monitor iron status (transferrin saturation and ferritin) before and during treatment; iron supplementation may be required.
- Closely monitor blood pressure and manage hypertension appropriately.
- Individualize the dose to achieve and maintain hemoglobin levels within the recommended target range (e.g., 10-11 g/dL) and avoid exceeding 11 g/dL.
- Avoid dose escalation or administration more frequently than recommended.
Patient Guidelines
- Do not shake the syringe or vial, as this can denature the protein.
- Store in the refrigerator (2-8°C), do not freeze, and protect from light.
- Report any signs of allergic reaction (e.g., rash, difficulty breathing) or severe headache immediately.
- Do not stop treatment without consulting your doctor.
- Monitor blood pressure regularly as instructed by your healthcare provider.
Missed Dose Advice
If a dose is missed, administer it as soon as remembered, then adjust the timing of subsequent doses. Do not take a double dose to make up for a missed one.
Driving Precautions
Darbepoetin alfa typically does not impair the ability to drive or operate machinery. However, if you experience side effects like headache or fatigue, exercise caution.
Lifestyle Advice
- Maintain a balanced diet rich in iron if advised by your doctor.
- Adhere to any fluid or dietary restrictions prescribed for chronic kidney disease.
- Manage hypertension through diet, exercise, and medication as recommended.
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