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jinbeixin firsekibart injection acute gouty arthritis attack 200mg 1

Description

 Indication & Scope

JinBeiXin® Firsekibart Injection treats acute gouty arthritis attacks in adult patients who have contraindications, intolerance or insufficient therapeutic response to NSAIDs and/or colchicine, and who are unsuitable for repeated long-term corticosteroid therapy.

  • Mechanism: Firsekibart is a fully humanized monoclonal antibody targeting interleukin-1 beta (IL-1β). It specifically binds and neutralizes circulating IL-1β, the core inflammatory cytokine triggering gout joint swelling and pain after urate crystal deposition. It blocks downstream inflammatory cascade reactions, rapidly relieves acute gout attack joint pain and swelling, and reduces repeated gout flare recurrence risk over long-term administration.
  • Drug class: Humanized anti-IL-1β monoclonal antibody biologic; targeted anti-gout inflammatory therapeutic agent.
  • Clinical use: Rapid relief of severe acute gouty arthritis flares for patients unfit for standard first-line gout medicines (NSAIDs, colchicine, repeated steroids). It achieves fast pain relief within 24 hours post single injection and extends the interval between subsequent gout attacks, providing long-term joint inflammation control without repeated oral anti-inflammatory drug side effects.
Specification
Generic Name Firsekibart Injection
Brand Name JinBeiXin
Ingredient Firsekibart
Dosage Form Injection
Package 200mg(1.33ml)*9 vials*4 boxes
Conditions Treated Adult patients suffering from acute gouty arthritis episodes who cannot use NSAIDs/colchicine, gain no symptom relief from these standard drugs, or cannot receive repeated steroid hormone courses for gout management
Taboos Patients with severe hypersensitivity or anaphylaxis to firsekibart or injection lyophilized powder excipients; patients with active uncontrolled severe systemic infectious diseases (active tuberculosis, sepsis, severe pneumonia); patients with severe decompensated liver cirrhosis (Child-Pugh Class C); pregnant women without specialist risk assessment
Place of origin China
Prescription type Prescription-only
Storage Conditions Unreconstituted lyophilized powder vials refrigerated at 2°C–8°C, stored in original light-proof packaging, protected from freezing. Do not shake reconstituted liquid violently after dissolving powder
Manufacturer Changchun GenScience Pharmaceutical Co., Ltd.
Registration Authority National Medical Products Administration (NMPA), China
Approval number S20260025
Approval Date Apr 29, 2026
Shelf Life 24 months

How to use ?

Recommended Dose: Standard single subcutaneous injection of 200mg reconstituted solution for one acute gout attack treatment. Additional maintenance dosing cycles can be administered under rheumatologist guidance to prevent repeated gout flares.

 

Time: Inject the reconstituted subcutaneous solution as early as possible within 48 hours after the onset of acute gout joint pain to maximize rapid anti-inflammatory pain relief effects. Dosing timing has no connection with meal intake.

 

Instructions for use: Only reconstitute the lyophilized powder with the matching sterile solvent provided in the product package before injection. Administer subcutaneously to upper arm, thigh or abdominal wall, rotate injection sites each administration. Do not inject intravenously or intramuscularly. Screen all patients for active infectious diseases including tuberculosis before initial injection. Avoid live attenuated vaccines during full treatment duration.

 

Interaction: No direct pharmacokinetic conflicts with urate-lowering gout medicines such as allopurinol or febuxostat; combined use can simultaneously control acute flares and reduce blood uric acid levels. Concomitant systemic immunosuppressants slightly raise severe infection risk and require regular infectious disease screening. Oral NSAIDs can be temporarily used at low doses for residual mild pain under doctor supervision.

 

Side effects:

1. Common mild adverse reactions: injection-site redness, mild itching or slight swelling, transient mild headache, upper respiratory tract mild cold symptoms.

2. Severe rare adverse reactions: severe anaphylactic allergic reaction, worsening of active systemic infection, persistent elevated liver transaminase levels, severe joint infection at injection-adjacent areas.

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, indicatiaon, 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

Which gout patients are eligible to receive Firsekibart Injection for acute painful gout attacks?

Adult gout sufferers who cannot take NSAIDs or colchicine, get no pain relief from those standard drugs, or cannot use repeated steroid hormone treatments for gout.

When is the best time to receive Firsekibart Injection after patients' gout joint pain suddenly flares up?

Patients should get Firsekibart Injection the subcutaneous injection within the first 48 hours of acute gout attack onset to achieve the fastest joint pain and swelling relief effect.

What patients cannot receive Firsekibart Injection anti-gout monoclonal antibody injection at all?

People with severe drug allergy to the injection powder, patients with untreated serious systemic infections such as active tuberculosis, and severe late-stage liver cirrhosis patients are fully contraindicated.

Can patients take regular blood uric acid lowering tablets together with Firsekibart Injection treatment?

Yes, urate-lowering medicines like febuxostat can be used alongside Firsekibart to both stop acute pain and lower long-term blood uric acid levels.

JinBeiXin® | Firsekibart Injection | Acute Gouty Arthritis Attack | DengYueRX

INN: Firsekibart Injection
Indications: Acute gouty arthritis attack
Dosage Form: Injection
Strength: 200mg(1.33ml)/vial

Low MOQ

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