Darbetin 100mcg/.5ml Injection

✔️ Dosage

Chronic Renal Failure–Associated Anemia

Darbetin may be administered subcutaneously or intravenously to increase hemoglobin levels to not greater than 12 g/dL (7.5 mmol/L).
Subcutaneous administration is preferred in patients not undergoing hemodialysis to reduce venous access requirements.

Treatment consists of two phases: correction and maintenance.

Adult Patients

Correction Phase

Initial dose: 0.45 µg/kg body weight once weekly (SC or IV)

Alternative dosing for non-dialysis patients (SC only):

0.75 µg/kg once every two weeks

1.5 µg/kg once monthly

Maintenance Phase

Dialysis patients:

Once weekly or once every two weeks

Patients switching from weekly to biweekly dosing should receive twice the previous weekly dose

Non-dialysis patients:

Once weekly, once every two weeks, or once monthly

Patients switching from biweekly to monthly dosing should receive twice the prior biweekly dose

Pediatric Patients (≥1 year of age)

Correction Phase

Initial dose: 0.45 µg/kg once weekly (SC or IV)

Alternative for non-dialysis patients: 0.75 µg/kg once every two weeks (SC)

✔️ Common and serious adverse events may include:

• Hypertension
• Thromboembolic events
• Stroke
• Convulsions
• Allergic reactions
• Skin rash or erythema
• Pure Red Cell Aplasia (PRCA)

✔️ Maintenance Phase

Once weekly or once every two weeks

Children <6 years may require higher maintenance doses than older pediatric patients

Non-dialysis patients ≥11 years may transition to once-monthly dosing after achieving target hemoglobin, using twice the prior biweekly dose

Safety and efficacy have not been established in children below 1 year of age.

✔️ Chemotherapy-Induced Anemia

Administer subcutaneously in patients with hemoglobin ≤10 g/dL

Target hemoglobin should not exceed 12 g/dL

Recommended dosing:

500 µg once every three weeks, or

2.25 µg/kg once weekly

If there is no adequate clinical response after 9 weeks, continuation of therapy is unlikely to provide benefit.

✔️ Pregnancy & Lactation

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women

It is unknown whether Darbepoetin alfa is excreted in human milk

Caution is advised when administering to breastfeeding women

✔️ Use Darbetin with caution in patients with:

Controlled hypertension

Seizure disorders

History or suspicion of PRCA

Known hypersensitivity to erythropoiesis-stimulating agents

✔️ Storage Conditions

Store at 2°C to 8°C

Do not freeze or shake

Protect from light

Keep in original carton until use

Do not use if the product has been shaken or frozen