China's Teprotumumab N01(替妥尤单抗N01注射液):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Teprotumumab N01

Teprotumumab N01 Injection achieves a breakthrough in non-invasive precision therapy compared with traditional hormone therapy and surgical treatment, and also exhibits favorable overall safety profiles with no severe adverse reactions reported and all adverse reactions showing a good prognosis.

Indications

Teprotumumab N01 Injection is indicated for the treatment of thyroid eye disease.

Overview

Generic Name

Teprotumumab N01 Injection,替妥尤单抗N01注射液

Brand Name

信必敏

Drug Type

Rx Drug,targeted drug

Approval No.

国药准字S20250013

Active Ingredient

Teprotumumab N01

Dosage Form

500mg(10ml)/vial

Specification

Injection

Description

Teprotumumab N01 Injection is a clear to slightly opalescent, colorless to pale yellow liquid.

Expiry Date

18 months

Manufacturer

Innovent Biologics (Suzhou) Co., Ltd.

Storage

Store and transport at 2℃ to 8℃, protected from light.

Dosage and Administration

Recommended dosage: The initial dose is 10 mg/kg, followed by a maintenance dose of 20 mg/kg administered once every 3 weeks, for a total of 8 doses.

Contraindications

This product is contraindicated in patients with hypersensitivity to teprotumumab N01 or any of the excipients in the formulation.

Adverse Reactions

Immune-related Reactions: Infusion reactions such as fever, chills and headache may occur; treatment should be suspended if severe reactions develop.

Infection Risk: As the drug may suppress the immune system, patients are susceptible to bacterial, viral or fungal infections (e.g., upper respiratory tract infection, pneumonia, etc.).

Hypersensitivity Reactions: Some patients may experience skin rash and pruritus; severe anaphylactic shock may occur in very rare cases.

Gastrointestinal Discomfort: Symptoms such as nausea and diarrhea are usually mild and self-relieving.

Use in Special Populations

Use in Pregnancy and Lactation

Currently, there are no clinical data available on the use of teprotumumab N01 in pregnant women. However, based on the potential risks to the fetus, Teprotumumab N01 Injection is contraindicated during pregnancy.

It is recommended that women of childbearing potential, as well as men whose partners are of childbearing potential, adopt effective contraceptive measures prior to the initiation of teprotumumab N01 treatment, during the treatment period, and within 6 months after the last dose.

There are no data regarding the excretion of teprotumumab N01 or its metabolites in human milk, nor the effects on breastfed infants or milk production. It is recommended that patients discontinue breastfeeding during teprotumumab N01 treatment.