Darbagen
Generic Name
darbagen
Manufacturer
Various Manufacturers
Country
Global, various countries
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Description
Overview of the medicine
Darbagen (Darbepoetin alfa) is an erythropoiesis-stimulating agent (ESA) used to treat anemia associated with chronic kidney disease (CKD) and chemotherapy-induced anemia in cancer patients. It works by stimulating the bone marrow to produce red blood cells.
Uses & Indications
Dosage
Adults
CKD (not on dialysis): 0.45 mcg/kg IV or SC once every 4 weeks, or 0.75 mcg/kg SC once every 2 weeks. CKD (on dialysis): 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. Chemotherapy-induced anemia: 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks.
Elderly
No specific dose adjustment is typically required based solely on age, but close monitoring of hemoglobin and side effects is recommended.
Renal_impairment
Dosage adjusted to maintain target hemoglobin levels (10-12 g/dL). Closely monitor hemoglobin.
How to Take
Administer by subcutaneous (SC) injection or intravenous (IV) injection. For SC administration, rotate injection sites. Do not shake the syringe. Follow aseptic technique.
Mechanism of Action
Darbagen (Darbepoetin alfa) stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It interacts with the erythropoietin receptor on progenitor cells in the bone marrow, stimulating red blood cell production, differentiation, and maturation.
Pharmacokinetics
Onset
Hemoglobin levels typically begin to rise within 2-6 weeks of initiation.
Excretion
Mainly renal excretion of intact or partially degraded drug.
Half life
Approximately 49 hours after subcutaneous administration and 21 hours after intravenous administration in CKD patients.
Absorption
Following subcutaneous administration, bioavailability is approximately 37% in CKD patients. Peak plasma concentrations are reached 48-72 hours post-SC dose.
Metabolism
Primarily through proteolysis (degradation of proteins).
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure Red Cell Aplasia (PRCA) that begins after treatment with any erythropoietin protein.
- Serious allergic reactions to darbagen (Darbepoetin alfa) or any component of the product.
Drug Interactions
Other ESAs
Should not be used concomitantly with other erythropoiesis-stimulating agents.
Iron supplements
May be required to ensure adequate iron stores for effective erythropoiesis, especially if iron deficiency is present.
Storage
Store refrigerated 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, a condition characterized by abnormally high levels of red blood cells. Management involves phlebotomy (blood letting) to reduce hemoglobin and hematocrit levels, and supportive care for symptoms. Monitor blood pressure closely.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. It is not known whether Darbepoetin alfa is excreted in human milk. Exercise caution when administering to a nursing mother.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure Red Cell Aplasia (PRCA) that begins after treatment with any erythropoietin protein.
- Serious allergic reactions to darbagen (Darbepoetin alfa) or any component of the product.
Drug Interactions
Other ESAs
Should not be used concomitantly with other erythropoiesis-stimulating agents.
Iron supplements
May be required to ensure adequate iron stores for effective erythropoiesis, especially if iron deficiency is present.
Storage
Store refrigerated 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, a condition characterized by abnormally high levels of red blood cells. Management involves phlebotomy (blood letting) to reduce hemoglobin and hematocrit levels, and supportive care for symptoms. Monitor blood pressure closely.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. It is not known 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 to 36 months from manufacturing date, when stored properly. Check individual product label.
Availability
Available in pharmacies and hospitals
Approval Status
FDA/DGDA approved
Patent Status
Patent expired for innovator, biosimilars available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Darbepoetin alfa in treating anemia associated with CKD and chemotherapy-induced anemia. Ongoing research continues to explore its use and long-term outcomes.
Lab Monitoring
- Hemoglobin levels: Monitor weekly or bi-weekly until stable, then regularly to avoid exceeding 12 g/dL.
- Blood pressure: Monitor regularly, especially during initiation and dose adjustments.
- Iron status: Assess iron stores (ferritin, transferrin saturation) and supplement if needed.
- Renal function: Monitor creatinine and BUN in CKD patients.
Doctor Notes
- Target hemoglobin should not exceed 12 g/dL due to increased cardiovascular risk.
- Ensure adequate iron stores before and during darbagen therapy.
- Monitor blood pressure closely, especially in patients with pre-existing hypertension.
- Educate patients on symptoms of thrombotic events and PRCA.
Patient Guidelines
- Do not shake the pre-filled syringe or vial.
- Store refrigerated and protect from light.
- Do not use if the solution is cloudy or contains particles.
- Report any unusual side effects, especially signs of blood clots or severe allergic reactions, to your doctor immediately.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. Do not take a double dose to make up for a missed dose. Consult your doctor for specific instructions.
Driving Precautions
Darbagen (Darbepoetin alfa) is not expected to affect the ability to drive or operate machinery directly. However, if you experience side effects like headache, dizziness, or seizures, you should avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet as recommended by your doctor, especially adequate iron intake if advised. Stay hydrated.
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International brand names for this medicine. Click a brand to search for detailed information.
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