Darbesis
Generic Name
Darbepoetin Alfa 25 mcg
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
darbesis 25 mcg injection | ৳ 2,840.00 | N/A |
Description
Overview of the medicine
Darbesis 25 mcg Injection contains Darbepoetin Alfa, a recombinant human erythropoietin analog. It is used to treat anemia by stimulating the production of red blood cells in the bone marrow. It is particularly used in patients with chronic kidney disease (CKD) and in some cases of chemotherapy-induced anemia.
Uses & Indications
Dosage
Adults
Initial dose for CKD patients not on dialysis: 0.45 mcg/kg IV or SC once every four weeks, or 0.75 mcg/kg SC every two weeks. For CKD patients on dialysis: 0.45 mcg/kg IV or SC once weekly. Doses are adjusted to maintain hemoglobin levels.
Elderly
No specific dose adjustment is generally required for elderly patients, but careful monitoring of hemoglobin levels and blood pressure is recommended.
Renal_impairment
Primary indication for CKD patients. Dosage adjusted based on hemoglobin response and target levels. No additional dose adjustment beyond what is specified for CKD.
How to Take
Darbesis 25 mcg Injection can be administered intravenously (IV) or subcutaneously (SC). It should be administered 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 increased production of red blood cells and hemoglobin levels.
Pharmacokinetics
Onset
Onset of action is gradual, with clinically significant increases in hemoglobin typically observed after 2-6 weeks.
Excretion
Mainly through renal excretion and cellular uptake/degradation.
Half life
Approximately 25.3 hours after intravenous administration and 48.8 hours after subcutaneous administration in CKD patients.
Absorption
Slow and sustained absorption after subcutaneous administration. Bioavailability is approximately 37% for subcutaneous and 100% for intravenous.
Metabolism
Primarily metabolized by non-renal pathways; peptide cleavage occurs.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) that begins after treatment with darbepoetin alfa or other erythropoietin protein drugs.
- Serious allergic reactions to darbepoetin alfa or any component of the formulation.
Drug Interactions
Iron supplements
Iron supplementation is almost always required to support erythropoiesis, especially when initiating ESA therapy.
No specific drug interactions have been identified with Darbepoetin Alfa
Darbepoetin Alfa is not known to have significant drug-drug interactions. However, close monitoring is advised when used with other agents that might affect erythropoiesis or blood pressure.
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 may lead to symptoms of polycythemia, such as increased blood viscosity and potential for thromboembolic events. Management involves phlebotomy to reduce hematocrit levels.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy 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 administered to a nursing woman.
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 pharmacies
Approval Status
Approved by FDA and DGDA
Patent Status
Generic versions available, original patent expired for some regions
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, confirming its role in reducing the need for red blood cell transfusions.
Lab Monitoring
- Hemoglobin levels: Monitor weekly or bi-weekly until stable, then regularly.
- Hematocrit levels: Monitor regularly.
- Iron status: Assess serum ferritin and transferrin saturation (TSAT) regularly; iron supplementation may be needed.
- Blood pressure: Monitor and control blood pressure before and during therapy.
Doctor Notes
- Emphasize the importance of maintaining target hemoglobin levels (typically 10-11 g/dL) to minimize risks.
- Monitor blood pressure closely and manage hypertension effectively.
- Regularly assess iron stores and provide iron supplementation as needed, as inadequate iron is a common cause of poor ESA response.
- Educate patients on potential adverse events, particularly cardiovascular symptoms and signs of thrombosis.
Patient Guidelines
- Do not self-administer unless properly trained by a healthcare professional.
- Keep all appointments for your doctor and lab tests.
- Report any sudden severe headache, changes in vision, or numbness/weakness immediately.
- Do not shake the prefilled syringe.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. If it is almost time for the next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Darbesis 25 mcg Injection is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or other side effects, exercise caution.
Lifestyle Advice
- Maintain a healthy diet rich in iron, folic acid, and vitamin B12.
- Manage underlying conditions like hypertension and diabetes.
- Avoid smoking, as it can worsen cardiovascular risks.
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