huierning romiplostim injection 250 μg per package

Description

Indication & Scope

HuiErNing® (Romiplostim) is a recombinant thrombopoietin receptor agonist (TPO-RA) indicated for adult patients with chronic primary immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments such as corticosteroids or immunoglobulins. By activating thrombopoietin receptor (TPO-R)-mediated signaling, Romiplostim stimulates megakaryocyte proliferation and differentiation, thereby increasing platelet production and improving platelet counts.

Mechanism: Romiplostim is a peptibody that binds to and activates the thrombopoietin receptor (TPO-R), mimicking the action of endogenous thrombopoietin and stimulating megakaryocyte growth and platelet production.
Drug class: Recombinant thrombopoietin receptor agonist (TPO-RA).
Clinical use: Treatment of adult patients (≥18 years old) with chronic primary immune thrombocytopenia (ITP) who have had an inadequate response to other treatments, including corticosteroids and immunoglobulins.

Specification

Generic Name	Romiplostim
Brand Name	HuiErNing®
Ingredient	Each vial contains romiplostim.
Dosage Form	Powder for Injection (lyophilized powder for injection)
Package	250 μg/vial
Conditions Treated	Adult patients (≥18 years old) with chronic primary immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments such as corticosteroids or immunoglobulins.
Taboos	Hypersensitivity to romiplostim or any component of the product.
Place of origin	China
Prescription type	Prescription Drug (Rx)
Storage Conditions	Refer to the approved package labeling.
Manufacturer	Kyowa Kirin (China) Pharmaceutical Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	SJ20220001
Date of Revision	2022
Shelf Life	Refer to the approved package labeling

How to use ?

Recommended Dose: The recommended initial dose of Romiplostim is 1 μg/kg administered by subcutaneous injection once weekly. The dose should be adjusted according to platelet response to maintain platelet counts within the target range.

Time: Administer twice daily following the approved dosing schedule.

Instructions for use: Administer once weekly according to the approved dosing schedule.

Interaction: Romiplostim is a recombinant thrombopoietin receptor agonist and is not metabolized by cytochrome P450 enzymes. No clinically significant CYP-mediated drug interactions have been identified.

Side effects: Common adverse reactions may include headache, arthralgia, fatigue, nausea, insomnia, myalgia, and injection-site reactions. Other potential risks include thromboembolic events, increased bone marrow reticulin, and excessive platelet elevation.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What condition is HuiErNing used to treat?

HuiErNing is indicated for adult patients (≥18 years old) with chronic primary immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments such as corticosteroids or immunoglobulins.

How is HuiErNing administered?

HuiErNing is administered by subcutaneous injection once weekly. The dose is adjusted according to platelet response and clinical condition.

What are the common side effects of HuiErNing?

Common adverse reactions may include headache, arthralgia, fatigue, nausea, insomnia, myalgia, and injection-site reactions. Patients should be monitored for risks such as thromboembolic events and excessive platelet elevation.

How should HuiErNing be stored?

Store according to the approved product labeling. Storage conditions should follow the requirements specified in the official prescribing information.