China's Pegmolesatide(培莫沙肽注射液):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Pegmolesatide

Pegmolesatide Injection is the world's only approved marketed long-acting highly selective small peptide agonist of erythropoietin (EPO) receptor. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2023 and simultaneously included in the National Medical Insurance Catalog. It has a novel compound patent and has been authorized in China, the United States, Europe, Japan and other countries.

Indications

Pegmolesatide Injection is indicated for the treatment of anemia caused by chronic kidney disease (CKD), including:

Adult non-dialysis patients who have not received erythropoiesis-stimulating agent (ESA) treatment;

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

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

Overview

Generic Name

Pegmolesatide Injection,培莫沙肽注射液

Brand Name

圣罗莱

Drug Type

Rx Drug

Approval No.

0.5ml:国药准字H20230019;1ml:国药准字H20230020;1.5ml:国药准字H20230021

Active Ingredient

Pegmolesatide

Dosage Form

0.5ml/vial;1ml/vial;1.5ml/vial

Specification

Injection

Description

This product is a colorless or almost colorless clear and transparent liquid.

Expiry Date

24 months

Manufacturer

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

Storage

Protect from light, seal tightly and store under refrigeration (2-8℃).

Dosage and Administration

Before initiating treatment with Pegmolesatide Injection, other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory diseases, bleeding, etc.) should be corrected or ruled out.

The administration route is subcutaneous injection once every 4 weeks. This product must not be administered via intravenous injection.

This product should be used under the supervision and guidance of professional medical personnel with experience in the treatment of renal anemia (anemia of chronic kidney disease).

Contraindications

This product is contraindicated in the following patients:

Patients with uncontrolled hypertension;

Patients with hypersensitivity to the active ingredient of this product or any of its excipients.

Adverse Reactions

Common adverse reactions include injection site reactions (erythema, swelling, pain), headache, hypertension, etc. Serious but rare risks include hypersensitivity reactions (e.g., rash, dyspnea) and cardiovascular complications.

Special Populations

Pregnancy and Lactation

No clinical studies have been conducted in pregnant or lactating women. However, animal studies have shown that pegmolesatide exerts effects on pregnant animals and embryos, therefore, this product should be used with caution in pregnant or lactating women.

Pediatric Use

The safety and efficacy of this product in patients under 18 years of age have not been established.

Geriatric Use

In the conducted Phase II and III clinical studies, approximately 8% of the patients were aged 65 years and older, and no significant differences in the safety and efficacy of this product were observed between this population and other populations.

For more detailed drug information, please consult the official package leaflet.