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ESA Therapy for Renal Anemia
ESA Therapy for Renal Anemia.png
Erythropoietin (EPO) is an important glycoprotein hormone that is produced by the peritubular cells of renal cortex, that stimulates red blood cell production. EPO primarily exerts its biological effect by binding to receptors on erythroid progenitor cells, triggering their differentiation into mature erythrocytes.³˒⁴

It has been hypothesized that in patients with chronic kidney disease (CKD), the EPO-producing abilities of pericytes are reduced during the transition to myofibroblast, leading to the decreased production of EPO. This process worsened as the progression of CKD, leading to anemia on CKD patients, or known as renal anemia. The binding of endogenous EPO or recombinant analogs in ESAs creates a cellular signaling cascade that activates genes which promote cell proliferation and preventing apoptosis, resulting in elevation of hemoglobin (Hb) and hematocrit (Hct). ³˒⁴

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ESAs treatment on CKD patients has proven to be cardio-renal protective, reducing cardio-renal-anemia (CRA) syndrome which is a highly risky cardiovascular condition associated with CKD. Additionally, ESA treatment also proven to slows the progression of CKD and regresses left ventricular hypertrophy (LVH).⁵

Latest KDIGO guideline suggests ESA therapy should be initiated for adult CKD-ND (Not-on-dialysis) with Hb concentration < 10.0 g/dL (< 100 g/L). The objective of initial ESA therapy is to increase Hb concentrations of 1.0 to 2.0 g/dL (10 to 20 g/l) per month, while a rise in Hb greater than 2.0 g/dL should be avoided as it also increases the risk of related adverse events.⁶

The Global Rise of CKD and Anemia

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Currently, short-acting erythropoiesis-stimulating agents (ESAs) are still a very popular therapy for anemia in CKD. However, these agents often require frequent dosing, which can lead to issues with patient compliance and suboptimal management of anemia.

Doctor using tablet

ESA Therapy FOR
RENAL ANEMIA

Algorithm EFESA dosage calculation

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  • A. Warnings

    1. A dose capable of maintaining the least blood Hb level not requiring RBC transfusion shall be administered.

    2. After the drug administration, if the blood Hb level exceeds 12 g/dL, risks of SAEs of the cardiovascular system and death will increase.

    3. The frequency of deep vein thrombosis was high in patients who used EPOs preoperatively to reduce the transfusion of homologous RBCs.

    4. Antibody-mediated PRCA has been rarely reported after months to years of subcutaneous epoetin treatment in Chronic Renal Failure patients. If anti-erythropoietin, antibody-mediated PRCA is suspected, therapy with EFESA should be discontinued immediately. No other ESA therapy should be commenced because of the risk of cross-reaction. Appropriate therapy, such as blood transfusions, may be given to patients when indicated.

    5. In all patients, hemoglobin concentrations should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at hemoglobin concentrations above the range for the indication of use.

     

    B. Precautions

    This product must be carefully administered to any patients with:

    1. Renal anemia who are receiving EPOs.

    2. Hypertension (increased blood pressure has been reported after administering Efepoetin alfa, therefore, hypertensive patients must follow antihypertensive treatment and dietary control during treatment with this drug).

    3. History of drug hypersensitivity.

    4. Predisposition to allergy.

    5. Myocardial infarction, pulmonary infarction, and cerebral infarction (since thromboembolism resulting from administration of this drug was reported, this drug has a risk of aggravating or causing thromboembolism).

    6. Liver disease (Efepoetin alfa is eliminated through the liver, so patients with active liver disease shall be excluded).

    7. The safety and efficacy of EFESA have not been established in patients with the underlying hematologic disease (e.g hemolytic anemia, sickle cell anemia, thalassemia).

    8. Epilepsy.

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    C. Special cautions for drug administration:

    1. Avoid co-administering this drug with any other drug.

    2. Visually inspect to confirm absence of foreign matter or discoloration, if any, before administration, and do not use any vials where foreign matter is found or if the contents are discolored.

    3. Do not use any drugs with insoluble matter seen, or if the solution is turbid.

    4. Never use any drugs that have been opened previously or whose primary package has been damaged.

    5. Do not attempt to use any fluids that have been frozen.

    6. To avoid injection site pains, gently inject this drug at different sites at every administration.

     

    D. INTERACTIONS

    Any interactions of other medications with this product have not been studied.

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