Darbagen
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 |
|---|---|---|
| darbagen 40 mcg injection | ৳ 4,500.00 | N/A |
Description
Overview of the medicine
Darbepoetin alfa is an erythropoiesis-stimulating protein. It is used to treat anemia associated with chronic kidney disease (CKD) and anemia in cancer patients receiving chemotherapy.
Uses & Indications
Dosage
Adults
For CKD: Initial 0.45 mcg/kg IV/SC weekly or 0.75 mcg/kg every 2 weeks. For chemotherapy: Initial 2.25 mcg/kg SC weekly or 500 mcg SC every 3 weeks. Dosing is individualized based on hemoglobin levels.
Elderly
No specific dosage adjustment needed, but monitor closely due to potential comorbidities.
Renal_impairment
Primary indication for treatment; dosage adjusted based on hemoglobin response.
How to Take
Administered by subcutaneous (SC) or intravenous (IV) injection. Do not shake the syringe.
Mechanism of Action
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin, increasing red blood cell production.
Pharmacokinetics
Onset
Hemoglobin levels typically begin to rise within 2-6 weeks.
Excretion
Primarily via catabolism; minimal renal excretion.
Half life
Approximately 25-49 hours (IV) and 49 hours (SC).
Absorption
Slow and complete absorption after subcutaneous administration. Bioavailability approximately 37% (SC).
Metabolism
Catabolized like endogenous proteins.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure Red Cell Aplasia (PRCA) unrelated to erythropoietin treatment.
- Serious allergic reactions to Darbepoetin alfa.
Drug Interactions
No significant drug interactions
No specific drug interactions have been reported for Darbepoetin alfa. However, patients should inform their doctor about all medications they are taking.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
Overdose
Overdose can lead to polycythemia. Management involves symptomatic and supportive treatment. Phlebotomy may be performed if polycythemia develops.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to fetus. It is unknown if Darbepoetin alfa is excreted in human milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure Red Cell Aplasia (PRCA) unrelated to erythropoietin treatment.
- Serious allergic reactions to Darbepoetin alfa.
Drug Interactions
No significant drug interactions
No specific drug interactions have been reported for Darbepoetin alfa. However, patients should inform their doctor about all medications they are taking.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
Overdose
Overdose can lead to polycythemia. Management involves symptomatic and supportive treatment. Phlebotomy may be performed if polycythemia develops.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to fetus. It is unknown if 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 24-36 months, check manufacturer's label for exact expiry.
Availability
Hospitals, Clinics, Pharmacies
Approval Status
Approved (DGDA, FDA)
Patent Status
Off-patent (active ingredient)
Clinical Trials
Extensive clinical trials have established the efficacy and safety of darbepoetin alfa in treating anemia associated with CKD and chemotherapy.
Lab Monitoring
- Hemoglobin and hematocrit levels (regularly)
- Blood pressure (before and during treatment)
- Serum ferritin and transferrin saturation (TSAT) (to assess iron status)
- Renal function tests (for CKD patients)
Doctor Notes
- Monitor hemoglobin levels closely and individualize dose to achieve the lowest hemoglobin level sufficient to avoid red blood cell transfusions.
- Educate patients on the signs and symptoms of blood clots and allergic reactions.
- Avoid rapid increases in hemoglobin as this may increase cardiovascular risks.
Patient Guidelines
- Do not shake the syringe vigorously as it may denature the protein.
- Store the medicine in the refrigerator, but do not freeze it.
- Do not reuse syringes and dispose of them properly.
- Report any signs of allergic reaction (e.g., rash, itching, swelling) or blood clots (e.g., chest pain, difficulty breathing, swelling/pain in legs) immediately.
Missed Dose Advice
If a dose is missed, administer it as soon as it is remembered, unless it is almost time for the next scheduled dose. Do not double the dose.
Driving Precautions
No specific precautions, but patients should be aware of potential side effects like fatigue or dizziness that could impair driving ability.
Lifestyle Advice
- Maintain a healthy diet to ensure adequate iron intake, as iron supplementation may be required.
- Manage blood pressure as advised by your doctor to reduce cardiovascular risks.
- Adhere strictly to the prescribed treatment schedule and monitoring appointments.
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