China's Firsekibart(注射用伏欣奇拜单抗):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Firsekibart

Firsekibart for Injection is the first and only approved interleukin-1β (IL-1β) monoclonal antibody in China. Approved for marketing by the National Medical Products Administration (NMPA) in June 2025, it is indicated for the treatment of gout and serves as the exclusively approved targeted biological product for gout treatment in the country.

Indications

Firsekibart is indicated for the treatment of acute gouty arthritis in adults who are contraindicated to, intolerant of, or unresponsive to nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine, and in those who are not suitable for repeated use of corticosteroids.

Overview

Generic Name

Firsekibart for Injection,注射用伏欣奇拜单抗

Brand Name

金蓓欣

Drug Type

Rx Drug,targeted drug

Approval No.

200mg:国药准字S20250036;150mg:国药准字S20250035

Active Ingredient

Firsekibart

Dosage Form

200mg/vial;150mg/vial

Specification

Injection

Description

This product appears as a white or off-white lyophilized powder. After reconstitution with water for injection, it should be a colorless or pale yellow clear liquid, which may be opalescent.

Expiry Date

18 months

Manufacturer

Changchun GeneScience Pharmaceutical Co., Ltd.

Storage

Store and transport at 2-8°C, protected from light.

Dosage and Administration

This product must be administered under the guidance of physicians with relevant treatment experience.

Recommended Dosage and Administration Method

The recommended dose is 200mg, administered via subcutaneous injection.

Contraindications

This product is contraindicated in patients hypersensitive to the active ingredient of Firsekibart or any of its excipients.

Firsekibart should be used with caution or contraindicated during pregnancy in women.

Adverse Reactions

Injection site reactions: Erythema and pain, which can be relieved by local cold compress.

Immunosuppression-related risks: Increased risk of infection. Medical attention should be sought promptly if symptoms such as fever or cough occur.

Allergic reactions: Rare but may occur, manifesting as skin rash and dyspnea. Immediate drug withdrawal and emergency treatment are required upon occurrence.

Other reactions: Fatigue, gastrointestinal discomfort, etc. Most of these symptoms are self-resolving.

Use in Special Populations

Usage in Pregnant and Lactating Women

There are no data available on the use of Firsekibart in pregnant and lactating populations. Animal reproductive toxicity studies have confirmed that this product can cross the placental barrier. Therefore, this product should be used with caution or be contraindicated in pregnant and lactating patients.

Usage in Pediatric Patients

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

Usage in Geriatric Patients

No overall differences in safety or efficacy have been reported between geriatric patients (aged > 65years) and younger patients, but clinical data on geriatric patients are limited.

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