Darbagen 100mcg/0.5ml SC Injection

✔️ Side Effects

• Hypertension
• Stroke
• Thromboembolic events
• Convulsions
• Allergic reactions
• Rash/erythema
• Pure Red Cell Aplasia (PRCA)

✔️ Chronic Renal Failure (Adult & Pediatric):

Correction phase: Initial dose is 0.45 µg/kg body weight, given subcutaneously or intravenously once a week. Alternative doses for patients not on dialysis: 0.75 µg/kg every two weeks or 1.5 µg/kg once a month.

• Maintenance phase: In dialysis patients, continue the dose weekly or every two weeks. In non-dialysis patients, doses may also be administered weekly, bi-weekly, or monthly.

✔️ Pediatric population (≥1 year):

• Correction phase: Initial dose is 0.45 µg/kg body weight, subcutaneously or intravenously, once a week or 0.75 µg/kg every two weeks for non-dialysis patients.
• Maintenance phase: Ongoing dosing based on age, with patients under 6 years potentially needing higher doses. Monthly dosing is an option for those ≥11 years after achieving target hemoglobin.

✔️ Symptomatic Chemotherapy-Induced Anemia:

• Initial Dose: 500 µg (6.75 µg/kg) once every three weeks, or alternatively, 2.25 µg/kg weekly. Treatment should be reevaluated if there's inadequate response after 9 weeks.

✔️ Administration

• Do not shake or freeze Darbepoetin alfa.
• Protect the pre-filled syringe from light.
• Inspect the syringe for particulate matter or discoloration before use. Do not use if these are present.
• Discard any unused portion of the syringe.
• Do not dilute Darbepoetin alfa or administer with other drug solutions.

✔️ Interaction

• No formal drug interaction studies have been conducted with Darbagen.

✔️ Contraindications

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

✔️ Pregnancy & Lactation

• Pregnancy Category C. The excretion of Darbepoetin alfa in human milk is unknown. Use caution when administering to breastfeeding women.

✔️ Precautions & Warnings

• Use cautiously in patients with controlled hypertension, a history of seizures, PRCA, or suspected allergies to the product.

✔️ Storage Conditions

• Store at 2°C to 8°C. Do not freeze.
• Protect it from light and keep it in the carton until use.
• Do not use if shaken or frozen.