darbepoetin alfa

Action and Spectrum

Actions and Spectrum: 

Erythropoietin regulates red blood cell production by binding to erythroblasts on bone marrow surface. This leads to increased proliferation and differentiation of erythroblasts into mature red blood cells which are released into the bloodstream.  

This increases the number of circulating red blood cells by improving the oxygen-carrying capacity of the blood and reducing symptoms of anemia. 

Drug Interaction

Adverse Reaction

Adverse Reaction  

Frequency defined:  

>10% 

Cancer patients 

Diarrhea 

Fever 

Arthralgia 

Death 

Fatigue 

Edema 

Dizziness 

Headache 

Chronic kidney failure patients 

Hyper/hypotension 

Headache 

Nausea 

Abdominal pain 

Infectious disease 

Spasm 

Diarrhea 

Peripheral edema 

1-10% 

Cancer patients 

Hypertension 

Dyspnea 

Pulmonary embolism 

Myalgia 

Pneumonia 

vomiting 

Chronic kidney failure patients 

Limb pain 

Death 

Anemia 

Myocardial infarction 

Cough 

Dizziness 

Edema 

Cardiac arrest 

<1% 

Cancer patients 

Seizure 

Hypersensitivity encephalopathy 

Chronic kidney failure patients 

Seizure 

Hypersensitivity encephalopathy 

Transient ischemic attack 

Frequency not defined 

Venous thromboembolism 

Injection site thrombosis 

Tumor progression 

Immune hypersensitivity reaction 

Black Box Warning

Black box warning: 

The black box warning for this drug is increased risk of death, myocardial infarction, stroke, and thromboembolic events. 

The FDA advises using darbepoetin alfa at the lowest dose to avoid blood transfusions and maintain hemoglobin levels.  

Contraindication / Caution

Contraindications/caution:           

Contraindications 

Darbepoetin alfa is contraindicated for uncontrolled hypertension due to its potential to increase red blood cell count and potentially exacerbating hypertension symptoms.  

Patients with hypersensitivity to any component of the drug should also avoid it.  

PURE red cell aplasia (PRCA) can be a side effect of treatment with darbepoetin alfa or other erythropoietin protein drugs.  

Caution 

Darbepoetin alfa like other erythropoiesis-stimulating agents (ESAs) should be used cautious in certain patient populations.  

It may increase the risk of cardiovascular events especially in those with underlying cardiovascular disease.  

It should not be used to treat anemia in cancer patients not receiving chemotherapy or whose anemia is not due to cancer.  

The use of darbepoetin alfa in cancer patients may accelerate tumor progression and shorten overall survival. 

Dose adjustment is necessary to avoid blood transfusions and maintain hemoglobin levels. 

Pregnancy / Lactation

Pregnancy consideration: Insufficient data available 

Lactation: Excretion of the drug in human breast milk is unknown 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.   
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    
• Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    
• Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology 

Darbepoetin alfa is a recombinant form of erythropoietin that regulates red blood cell production. It stimulates red blood cell production by binding to erythroblasts on bone marrow precursor cells leading to increased proliferation and differentiation into mature red blood cells.  

Pharmacodynamics 

These cells are released into the bloodstream by increasing the number of circulating red blood cells and oxygen carrying capacity thus improving anemia symptoms. It can increase red blood cell count within 2-4 weeks of treatment with dose dependent effects. 

Pharmacokinetics 

Absorption:  

It absorbs rapidly after administration. 

Distribution:  

It is rapidly distributed throughout the body and has a high distribution volume. 

Metabolism:  

It has a short half-life and rapidly cleared from the body. 

Excretion:  

It is primarily excreted by the kidneys and has a low clearance rate 

Adminstartion

Administration 

It is administered subcutaneously every 1-3 weeks depending on the patient condition and treatment response. It is also administered intravenously into a vein with the exact dosage and frequency based on the patient condition. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: darbepoetin alfa 

Pronounced: [ DAR-be-POE-e-tin-AL-fa] 

Why do we use darbepoetin alfa? 

Darbepoetin alfa is used to treat anemia associated with chronic kidney disease, cancer chemotherapy, HIV infection, nonmyeloablative hematopoietic stem cell transplantation, and myelodysplastic syndromes. Patients with CKD who are on dialysis or have a GFR of less than 30ml/min are treated with darbepoetin alfa.