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 60 mcg injection | ৳ 5,505.31 | N/A |
Description
Overview of the medicine
Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) used to treat anemia associated with chronic kidney disease (CKD) or chemotherapy in cancer patients. It works by stimulating the bone marrow to produce red blood cells.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on indication, patient weight, and hemoglobin levels. For CKD patients not on dialysis, initial dose typically 0.45 mcg/kg SC or IV once every 4 weeks or 0.75 mcg/kg once every 2 weeks. For CKD patients on dialysis, initial dose typically 0.45 mcg/kg SC or IV once weekly or 0.75 mcg/kg once every 2 weeks. Doses are adjusted to maintain hemoglobin levels within the target range (e.g., 10-11 g/dL).
Elderly
No specific dose adjustment is generally required for elderly patients, but individual response and comorbidities should be considered.
Renal_impairment
Used to treat anemia in renal impairment; dosage is adjusted based on hemoglobin response and target levels.
How to Take
Administer subcutaneously (SC) or intravenously (IV). Do not shake the syringe. Visually inspect for particulate matter or discoloration prior to administration. Single-use vial/pre-filled syringe.
Mechanism of Action
Darbepoetin alfa stimulates erythropoiesis by binding to erythropoietin receptors on erythroid progenitor cells, mimicking the action of endogenous erythropoietin. It has a longer half-life than epoetin alfa due to increased glycosylation, allowing for less frequent dosing.
Pharmacokinetics
Onset
Hemoglobin levels typically begin to rise within 2-6 weeks of initiation.
Excretion
Mainly renal clearance, but also via non-renal mechanisms.
Half life
Approximately 21 hours following intravenous (IV) administration and 49 hours following SC administration in CKD patients.
Absorption
After subcutaneous (SC) administration, absorption is slow, with peak serum concentrations occurring between 48 and 72 hours. Bioavailability is approximately 37% in CKD patients.
Metabolism
Primarily catabolized; minimal hepatic metabolism.
Bioavailability
Approximately 37% (SC in CKD)
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure Red Cell Aplasia (PRCA) unrelated to erythropoietin therapy.
- Serious allergic reactions to darbepoetin alfa or its components.
Drug Interactions
No significant drug interactions
Darbepoetin alfa is not known to have significant direct drug-drug interactions, as it is primarily catabolized rather than metabolized by the cytochrome P450 system.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia (excess red blood cells), which may require phlebotomy. Management includes monitoring hemoglobin levels and providing supportive care.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if darbepoetin alfa is excreted in human milk; use with caution in breastfeeding women.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure Red Cell Aplasia (PRCA) unrelated to erythropoietin therapy.
- Serious allergic reactions to darbepoetin alfa or its components.
Drug Interactions
No significant drug interactions
Darbepoetin alfa is not known to have significant direct drug-drug interactions, as it is primarily catabolized rather than metabolized by the cytochrome P450 system.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
Overdose can lead to polycythemia (excess red blood cells), which may require phlebotomy. Management includes monitoring hemoglobin levels and providing supportive care.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if darbepoetin alfa is excreted in human milk; use with caution in breastfeeding women.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months when stored as recommended.
Availability
Pharmacies, hospitals, clinics
Approval Status
DGDA Approved
Patent Status
Generic available
Clinical Trials
Numerous clinical trials have established the efficacy and safety of darbepoetin alfa in treating anemia in CKD and chemotherapy-induced anemia. Ongoing research continues to explore optimal dosing strategies and long-term outcomes.
Lab Monitoring
- Hemoglobin and hematocrit levels (regularly, especially during initial therapy and dose adjustments).
- Blood pressure (regularly).
- Iron status (ferritin, transferrin saturation) - iron supplementation may be needed.
- Renal function (creatinine, BUN).
Doctor Notes
- Emphasize the importance of maintaining hemoglobin within the target range (10-11 g/dL) and avoiding higher levels due to increased risks.
- Monitor blood pressure closely and manage hypertension effectively.
- Assess iron status before and during treatment; iron supplementation is often necessary for optimal response.
Patient Guidelines
- Do not self-administer unless properly trained by a healthcare professional.
- Store in the refrigerator; do not freeze.
- Report any sudden increase in blood pressure or symptoms of blood clot (e.g., chest pain, difficulty breathing, swelling/pain in a leg) immediately.
- Do not exceed the prescribed dose or target hemoglobin levels.
Missed Dose Advice
If a dose is missed, administer it as soon as remembered. If it is almost time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Darbepoetin alfa is not known to impair the ability to drive or operate machinery. However, any side effects like dizziness should be considered.
Lifestyle Advice
- Maintain a healthy diet as advised by your doctor, especially if you have chronic kidney disease.
- Monitor blood pressure regularly at home if instructed.
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