Embardia(Darbepoetin alfa)
Therapeutic Group: Drugs for Hematological Disorder
Presentation
Embardia 25 mcg Injection: Each pre-filled syringe contains Darbepoetin alfa INN 25 mcg in 0.42 ml solution for injection.
Embardia 40 mcg Injection: Each pre-filled syringe contains Darbepoetin alfa INN 40 mcg in 0.40 ml solution
for injection.
Embardia 60 mcg Injection: Each pre-filled syringe contains Darbepoetin alfa INN 60 mcg in 0.30 ml solution for injection.
Description
Darbepoetin alfa is a re-engineered form of erythropoietin containing 5 amino acid changes. It has a 3-fold longer serum half-life compared to erythropoietin alpha and erythropoietin beta. It stimulates erythropoiesis
by the same mechanism as rHuEpo (binding and activating the Epo receptor) and is used to treat anemia.
Indications
Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to:
• Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis
• The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned Chemotherapy
Dosage & Administration
Recommended starting dose for CKD patients on dialysis:
• 0.45 mcg/kg intravenously or subcutaneously weekly, or
• 0.75 mcg/kg intravenously or subcutaneously every 2 weeks
• Intravenous route is recommended for patients on hemodialysis
Recommended starting dose for patients with CKD not on dialysis:
• 0.45 mcg/kg intravenously or subcutaneously at 4-week intervals
Recommended starting dose for cancer patients on chemotherapy:
• 2.25 mcg/kg subcutaneously weekly, or
• 500 mcg subcutaneously every 3 weeks
Side Effects
Patients with CKD: Adverse reactions in ≥ 10% of Darbepoetin alfa patients in clinical studies were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension.
Cancer Patients Receiving Chemotherapy: Adverse reactions in ≥ 1% of Darbepoetin alfa-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events.
Precautions
• Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using Darbepoetin alfa to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke
• Increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer
• Hypertension: Control hypertension prior to initiating and during treatment with Darbepoetin alfa
• Seizures: Darbepoetin alfa increases the risk for seizures in patients with CKD. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms
• PRCA: If severe anemia and low reticulocyte count develop during Darbepoetin alfa treatment, withhold Darbepoetin alfa and evaluate for PRCA
Use in Pregnancy & Lactation
Pregnancy: Based on animal data, may cause fetal harm.
Nursing Mothers: Exercise caution when Darbepoetin alfa is administered to a nursing woman.
Pediatric Use: Safety and efficacy not established in the initial treatment of anemic patients with CKD, in the transition from another erythropoietin in patients with CKD who are less than 1 year of age, or in pediatric
patients with cancer.
Drug Interaction
No formal drug interaction studies have been conducted with Darbepoetin alfa.
Over Dose
Darbepoetin alfa can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin alfa dosage and/or with phlebotomy, as clinically indicated.
Cases of severe hypertension have been observed following overdose with ESAs.
Storage
Store at 2°C to 8°C in a refrigerator. Do not freeze. Do not shake. Keep out of the reach of children.
Commercial Pack
Embardia 25 mcg Injection: Each box contains 1 pre-filled syringe containing 25 mcg Darbepoetin alfa.
Embardia 40 mcg Injection: Each box contains 1 pre-filled syringe containing 40 mcg Darbepoetin alfa.
Embardia 60 mcg Injection: Each box contains 1 pre-filled syringe containing 60 mcg Darbepoetin alfa.
