Darbagen
Generic Name
Darbepoetin alfa 60 mcg Injection
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| darbagen 60 mcg injection | ৳ 5,505.00 | N/A |
Description
Overview of the medicine
Darbepoetin alfa is a recombinant human erythropoietin analog, an erythropoiesis-stimulating protein. It is used to treat anemia associated with chronic kidney disease (CKD) and anemia caused by myelosuppressive chemotherapy in cancer patients.
Uses & Indications
Dosage
Adults
For CKD: Initial dose 0.45 mcg/kg administered intravenously or subcutaneously once weekly or 0.75 mcg/kg every 2 weeks. For chemotherapy-induced anemia: 2.25 mcg/kg SC weekly or 500 mcg SC once every 3 weeks. Doses are adjusted to maintain target hemoglobin levels.
Elderly
No specific dose adjustment is typically required for elderly patients, but individual response and comorbidities should be considered.
Renal_impairment
The primary indication is for anemia in CKD patients; dosage is adjusted based on hemoglobin levels and response, as described for adults.
How to Take
Darbagen-60 mcg injection can be administered subcutaneously (SC) or intravenously (IV). For SC administration, ensure proper technique after training by a healthcare professional. Do not shake the syringe.
Mechanism of Action
Darbepoetin alfa stimulates erythropoiesis by binding to erythropoietin receptors on progenitor cells in the bone marrow, leading to red blood cell production. It has a longer half-life than epoetin alfa due to increased glycosylation, allowing for less frequent dosing.
Pharmacokinetics
Onset
Erythroid response typically begins within 1-2 weeks, with significant increases in hemoglobin seen over 3-6 weeks.
Excretion
Mainly through receptor-mediated catabolism; minimal excretion of intact drug via kidneys.
Half life
Mean terminal half-life is approximately 49 hours for subcutaneous administration and 21 hours for intravenous administration.
Absorption
Subcutaneous absorption is slow and sustained, with peak concentrations reached in 2-3 days. Bioavailability is approximately 37% (CKD) to 53% (cancer).
Metabolism
Primarily cleared by erythropoietin receptor-mediated uptake and degradation, with minor renal excretion.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Known hypersensitivity to darbepoetin alfa or any component of the formulation.
- Pure Red Cell Aplasia (PRCA) unrelated to CKD when treated with erythropoietin products.
Drug Interactions
No significant direct drug-drug interactions
Darbepoetin alfa is not metabolized by CYP450 enzymes. No formal drug-drug interaction studies have been conducted. Monitor for effects of concomitant medications on blood pressure.
Storage
Store in a refrigerator at 2-8°C (36-46°F). Do not freeze. Protect from light. Do not shake. Keep out of the reach of children.
Overdose
Overdose can lead to polycythemia (excessive red blood cells), which may require phlebotomy (blood letting) to reduce blood viscosity. Supportive care should be provided.
Pregnancy & Lactation
Pregnancy Category C. 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. Exercise caution when administering to a nursing mother.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Known hypersensitivity to darbepoetin alfa or any component of the formulation.
- Pure Red Cell Aplasia (PRCA) unrelated to CKD when treated with erythropoietin products.
Drug Interactions
No significant direct drug-drug interactions
Darbepoetin alfa is not metabolized by CYP450 enzymes. No formal drug-drug interaction studies have been conducted. Monitor for effects of concomitant medications on blood pressure.
Storage
Store in a refrigerator at 2-8°C (36-46°F). Do not freeze. Protect from light. Do not shake. Keep out of the reach of children.
Overdose
Overdose can lead to polycythemia (excessive red blood cells), which may require phlebotomy (blood letting) to reduce blood viscosity. Supportive care should be provided.
Pregnancy & Lactation
Pregnancy Category C. 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. Exercise caution when administering to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months when stored as recommended.
Availability
Available in hospitals and retail pharmacies.
Approval Status
Approved by regulatory authorities (e.g., DGDA, FDA)
Patent Status
Patent expired for biosimilars in many regions, original product may still have some patent protection.
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of darbepoetin alfa in treating anemia in CKD and chemotherapy-induced anemia. Post-marketing surveillance continues.
Lab Monitoring
- Hemoglobin and hematocrit levels (regularly, especially at treatment initiation)
- Blood pressure (before and during therapy)
- Serum ferritin and transferrin saturation (to assess iron stores)
- Electrolytes (e.g., potassium in CKD patients)
Doctor Notes
- Emphasize strict adherence to hemoglobin targets (typically 10-11 g/dL) to minimize cardiovascular risks.
- Monitor blood pressure rigorously and manage hypertension effectively.
- Assess iron status before and during therapy; iron supplementation may be required.
- Educate patients on proper injection technique if self-administering and on symptoms requiring immediate medical attention.
Patient Guidelines
- Do not shake the prefilled syringe; shaking may denature the protein.
- Store in the refrigerator (2-8°C), protect from light, do not freeze.
- Report any signs of allergic reaction, chest pain, or symptoms of blood clots immediately.
- Follow your doctor's instructions regarding dose and administration precisely.
- Maintain regular blood pressure monitoring.
Missed Dose Advice
If a dose is missed, administer it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double doses.
Driving Precautions
Darbepoetin alfa is not known to directly impair the ability to drive or operate machinery. However, if you experience side effects like dizziness or seizures, you should avoid such activities.
Lifestyle Advice
- Maintain a healthy diet, rich in iron and other essential nutrients if recommended by your doctor.
- Manage underlying conditions like hypertension effectively.
- Avoid smoking and excessive alcohol consumption.
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