Pegmolesatide Injection.

This product is a colorless or almost colorless clear liquid.

【Indications】
This product is indicated for the treatment of anemia caused by chronic kidney disease, including:

1. Adult non-dialysis patients who have not received erythropoiesis stimulating agents (ESA);

2. Adult dialysis patients who are receiving short-acting erythropoietin treatment.

This product is not indicated as a replacement for red blood cell transfusion in patients requiring immediate correction of anemia.

【Specification】
(1)0.5ml:2.0mg

(2) 1ml: 4.0mg

(3) 1.5ml:6.0mg

【Dosage】
Before starting treatment with this product, other causes of anemia (such as vitamin deficiency, metabolic or chronic inflammatory diseases, bleeding, etc.) should be corrected or excluded.

The administration method is subcutaneous injection once every 4 weeks. This product must not be administered intravenously.

This product should be used under the supervision and guidance of professional medical personnel with experience in treating renal anemia.

1. Non-dialysis patients not receiving ESA therapy:

initial dose

Start treatment with this product when the patient’s hemoglobin (Hb) level falls below 10.0g/dL.

The initial dosage of this product is 0.04 mg/kg, subcutaneous injection once every 4 weeks.

Dosage adjustment

During the initial treatment phase, it is recommended to monitor Hb levels every 2 weeks until they stabilize, and then every 4 weeks. During treatment, it is recommended that the dose be adjusted every 4 weeks based on the patient’s current anemia degree and changes in Hb in the past 4 weeks, so that the Hb level reaches the target range (generally 10.0~12.0 g/dL, please refer to clinical guidelines for individualized adjustments ), the maximum single dose is 0.08mg/kg (calculated based on kilogram body weight).

Recommended dosage adjustments are as follows:

If the Hb level is within 12.0~13.0g/dL, reduce the dose by 25%.

If the Hb level exceeds 13.0 g/dL, suspend administration until Hb is ≤ 12.0 g/dL, then reduce the dose by 25% of the last dose.

During the initial treatment phase, if the Hb level rises too fast, the dosage can be reduced or the dosage can be suspended according to the physician’s judgment to alleviate the rapid response: if the Hb level rises by more than 1.0g/dL within 2 weeks or within 4 weeks If the increase exceeds 2.0 g/dL within 2 weeks, the dose of pemoxatide can be reduced by 25%; if the increase exceeds 2.0g/dL within 2 weeks or exceeds 3.0g/dL within 4 weeks, the dose of pemoxatide can be reduced. The dose of peptide is reduced by 50%.

If the dosage of pemoxatide needs to be increased to maintain Hb above 10.0 g/dL, the dosage can be increased every 4 weeks at a rate of approximately 25% or 50% of the current dosage.

Dosage adjustments should be made no more frequently than once per month.

2. Dialysis patients who are receiving Lixuebao treatment:

Patients who are receiving short-acting erythropoietin therapy and have stable hemoglobin levels may experience significant fluctuations in Hb levels after switching to this product. It is recommended to conduct a full benefit-risk assessment before switching and switch with caution.

initial dose

Chronic kidney disease (CKD) dialysis patients who are currently being treated with Lixuebao can switch to this product for treatment. The initial dose of this product should be converted according to Table 1 based on the patient’s weekly dosage of Lexuebao before dressing change. During the replacement process, patients were required to wait one week after their last dose of erythropoietin before receiving their first dose of pemoxatide.