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EFESA Dosage and Administration
Dosage and Administration.png

*TSAT = Transferrin Saturation, SF = Serum Ferritin. Recommended adequate iron status as follows;

  • TSAT ≥ 20%, SF 100-200 ng/dL or

  • TSAT > 50% or

  • TSAT ≥ 20%, SF > 500 ng/dL or

  • TSAT <20%, SF > 800 ng/dL or

  • Functional iron deficiency (TSAT < 20%, SF ≥ 100 ng/dL)

​

For more detailed information regarding dosage and conversion to EFESA, please contact clinical.info@kg-biologics.com

EFESA dosing and administration

In adult patients, EFESA is administered with recommended starting dose for anemia in CKD not on dialysis;

  • 4 mcg/kg body weight administered subcutaneously, subsequent doses will be titrated to optimal hemoglobin target and will be administered once every two weeks.

  • When initiating or adjusting therapy, monitor hemoglobin levels at least biweekly until stable, then monitor at least monthly. Administer Efesa subcutaneously in the abdomen, arm or thigh.

  • If the increase in Hb is less than 1.0 g/dL over 4 weeks and iron stores are adequate, the dose may be increased by approximately 25% of the previous dose. Further increases may be made at 4-week intervals when the Hb is in the specified target Hb range.

  • If the rate of rise in Hb is greater than 2 g/dL in one month or the Hb increases by more than 1.0 g/dL in a 2-week period, the dose should be decreased by approximately 25%.

  • If the Hb is increasing and exceeds 11.5 g/dL, the dose should be reduced by approximately 25%.

  • If the Hb continues to increase and exceeds 12 g/dL, dosing should be temporarily withheld until the Hb begins to decrease and restart dosing when Hb level falls back to the predetermined Hb level for restarting (ie ≤11.5 g/dL) based on the next scheduled Hb test results, at which point therapy should be reinitiated at a dose approximately 25% below the previous dose.

  • During maintenance period, dosage of Efesa should be adjusted to maintain the Hb within the target range (10 g/dL to 12 g/dL). Efesa could be administered using the same every-two-week dose. It could also be administered every-four-week at double the two weekly dosage.

EFESA dosage calculator

A calculator for determining the Efesa dosage in the initial/correction phase or the maintenance phase.

  • Initial/Correction Phase (Hb 8 - <10 g/dL)

    The Efesa dosage determination phase is administered every two weeks until Hb levels reach the range of 10-12 g/dL.

    Terms and Conditions:

    • For anemia patients (Hb levels 8 - <10 g/dL) with non-dialysis CKD who have never received EFESA/another ESA before or have received it but not within the last 3 months.

    • The calculation results are for informational purposes only. Efesa dosage decisions must be made by a qualified physician based on the patient's clinical assessment.

    Body weight

    kg

    Hb level

    g/dL

  • CALCULATE
    RESET

    Terms and Conditions:

    • The maximum dose of EFESA is 8 mcg/kg body weight (BW).

    • The results of this calculation are provided for informational purposes only. The decision regarding the EFESA dose must be made by a qualified doctor based on the clinical assessment of the patient.

    Maintenance Phase

    Once the Hb level is stable at 10-12 g/dL, EFESA can be administered at intervals of 2 weeks or 4 weeks.

    Hb level 2 weeks ago

    g/dL

    Dose 2 weeks ago

    mcg/2 weeks

    Body weight

    kg

    Hb level

    g/dL

250 mcg

Setiap 2 minggu

0,25 mg/mL

Setiap 2 minggu

Rekomendasi Preskripsi:
1 PFS Efesa 0,3 mg/0,3 mL

Setiap 2 minggu

PFS: Prefilled Syringe

EFESA is now available in 2 strengths
0.3 mg/0.3 mL prefilled-syringe EFESA injection for subcutaneous use

Pack size:

1 pre-filled syringe

0.6 mg/0.6 mL prefilled-syringe EFESA injection for subcutaneous use

Pack size:

1 pre-filled syringe

  • 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.

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