Darbagen 60

Indications

Darbagen is prescribed for treating anemia caused by:

1. Chronic Kidney Disease (CKD): Effective for both dialysis and non-dialysis patients.
2. Chemotherapy-Induced Anemia: Applicable when patients are undergoing myelosuppressive chemotherapy, with at least two months of planned treatment remaining.

Use this medication only under the guidance of a registered physician.

Pharmacology

Darbepoetin alfa, the active ingredient in Darbagen, is an erythropoiesis-stimulating protein created using recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. It is a 165-amino acid protein that has 5 N-linked oligosaccharide chains, differing from recombinant human erythropoietin, which contains 3 chains. This difference arises from two additional N-glycosylation sites due to specific amino acid substitutions in its peptide backbone.

Dosage Guidelines

Treatment for Anemia in Chronic Renal Failure:
The dosage should be tailored based on symptoms, age, gender, and disease burden. Administration can be subcutaneous (SC) or intravenous (IV), targeting hemoglobin levels below 12 g/dl (7.5 mmol/l).

Adult Patients:

1. Correction Phase:
   • Initial dose:
     • SC or IV: 0.45 µg/kg once weekly.
     • SC (non-dialysis patients): 0.75 µg/kg every two weeks or 1.5 µg/kg once a month.
2. Maintenance Phase:
   • For dialysis patients: Administer weekly or bi-weekly injections. Switching to bi-weekly requires a dose twice the previous weekly amount.
   • For non-dialysis patients: Administer weekly, bi-weekly, or monthly injections, adjusting doses based on hemoglobin levels.

Pediatric Patients (≥1 year old):

1. Correction Phase:
   • Initial dose: SC or IV injection of 0.45 µg/kg once weekly, or 0.75 µg/kg every two weeks (non-dialysis patients).
2. Maintenance Phase:
   • Continue weekly or bi-weekly injections. Younger children (<6 years) may require higher doses.

Cancer Patients with Chemotherapy-Induced Anemia:

• Administer SC when hemoglobin is ≤10 g/dl (6.2 mmol/l), targeting levels below 12 g/dl (7.5 mmol/l).
• Initial dose:
  • 500 µg every three weeks or 2.25 µg/kg weekly.
• Discontinue treatment if no improvement is observed after nine weeks.

Use this medication only under the guidance of a registered physician.

Administration Instructions

• Avoid shaking or freezing the pre-filled syringe.
• Keep the syringe protected from light.
• Check for discoloration or particles before use; do not use if abnormalities are observed.
• Discard any unused portion; do not mix Darbepoetin alfa with other solutions.

Use this medication only under the guidance of a registered physician.

Drug Interactions

No formal studies on drug interactions with Darbagen have been conducted.

Contraindications

Avoid using Darbagen in cases of:

• Uncontrolled hypertension.
• Pure Red Cell Aplasia (PRCA).
• Severe allergic reactions.

Possible Side Effects

• Hypertension
• Stroke
• Thromboembolic events
• Seizures
• Rash or erythema
• Pure Red Cell Aplasia (PRCA)

Pregnancy & Lactation

• Pregnancy Category C: The effects of Darbepoetin alfa during pregnancy are unclear.
• Unknown if excreted in breast milk; caution is advised for nursing mothers.

Precautions & Warnings

Exercise caution in patients with:

• Controlled hypertension
• Seizure disorders
• PRCA
• Allergic sensitivity to the product

Overdose Management

Excessive doses can elevate hemoglobin levels beyond the target range. In such cases, treatment adjustments, dosage reductions, or phlebotomy may be necessary.

Therapeutic Class

Hematopoietic Agents

Storage Guidelines

• Store at 2°C to 8°C.
• Protect from light and avoid freezing or shaking.
• Keep the medication in its original packaging until use.