top of page
red_diagonal_geometric_shape_with_halftone_detailed_background_edited.jpg
Logo Efesa with (R).png

EFESA (Efepoetin Alfa) For Renal Anemia

EFESA which contains efepoetin alfa (rhEPO-hyFc) is a long-acting erythropoietin-hybrid Fc (hyFc) fusion protein that is indicated for the treatment of anemia associated with CKD in non-dialysis (CKD-ND) subjects.

WHAT IS EFESA?

Efepoetin alfa is a recombinant form of human EPO and hybrid Fc (hyFc) fragment consisting of two subunits

efesa structure-Photoroom.png

Each subunit contains an erythropoietin molecule linked to a hybrid Fc fragment of c-terminal of CH2 and CH3 regions from IgG4 and N-terminal of CH2 region and the hinge sequence from IgD. Two subunits are joined by a single disulfide bond at the hinge region of each subunit.

DISCOVER HOW EFESA WORKS

Watch this video to see how EFESA’s advanced hyFc fusion protein technology enhances red blood production

Side Effects Information

Understanding potential side effects helps ensure safe and effective treatment

Like all drugs, EFESA may causes side effects, although it may not happen to everyone.

Possible side effects include (% of total subject from our clinical trial):

  • Hypertension – 2,1%

  • Diarrhea, vomiting – 1%

  • Dizziness, headache – 1%

  • Oropharyngeal pain, leukocytosis, blood and lymphatic system disorder – 1%

  • Iron deficiency anemia – 0,5%

  • Insomnia – 0,5%

Side effects listed are not what will possibly happen on EFESA usage.

 

What to Do if You Experience a Side Effect

If you notice anything unusual or experience a potential side effect, your first and most important step is to contact your physician immediately. Your healthcare provider is your primary resource for any medical concerns and can provide the appropriate diagnosis and treatment. Please do not attempt to manage side effects by yourself.

 

How to Report a Side Effect

By reporting side effects, you can help provide more information about the safety of this medicine. You can report directly to our safety monitoring team by sending an email with the details of your experience to: pv.kgbio@kg-biologics.com

  • 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.

    ​

    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.

bottom of page