Firsekibart For Injection Application Scope

Firsekibart is a fully humanized immunoglobulin G4-λ2 monoclonal antibody that specifically targets and inhibits interleukin-1 beta (IL-1β), a key cytokine in inflammatory responses. It is developed for inflammation-related conditions, including gouty arthritis, and is the first IL-1β inhibitor approved in China for this indication.

Firsekibart For Injection

Characteristics

Ingredients: The active ingredient is Firsekibart, a monoclonal antibody.
Properties: The reconstituted solution is colorless or light yellow, free of particles, and non-turbid.
Packaging Specification: 200 mg/vial.
Storage: Reconstituted solution should be used immediately; if not, store at 2-8°C for up to 24 hours or at room temperature for up to 2 hours. Storage conditions for the unreconstituted product should follow the certificate of analysis or manufacturer guidelines.
Expiry Date: Refer to product packaging or certificate of analysis.
Executive Standard: Refer to product packaging or certificate of analysis.
Approval Number: approved by China’s NMPA on July 2, 2025, for gouty arthritis.
Date of Revision: Refer to product packaging or certificate of analysis.
Manufacturer: Changchun GeneScience Pharmaceutical Co., Ltd.

Guidelines for the Use of Firsekibart For Injection

Dosage and Administration:
- Recommended Dose: 200 mg as a single subcutaneous injection. No dose adjustment is needed for patients with mild hepatic or mild to moderate renal impairment, though clinical experience is limited.
- Administration: Reconstitute by drawing 1.3 mL of sterile water for injection and injecting it slowly into the vial. Gently shake for about 5 minutes, let stand for 5 minutes, and repeat until fully dissolved. Tap the vial to remove residual liquid from the walls. Withdraw 1.33 mL using a disposable transfer device, then replace with an injection needle for subcutaneous administration. Suitable sites include the upper thigh, abdomen, upper arm, or buttocks. Rotate injection sites to avoid soreness, and avoid damaged, bruised, rash-affected, or scarred areas. Discard remaining solution immediately after use. Dispose of vials, syringes, and needles per local regulations.
- Missed Dose: Not applicable, as current data supports single-dose administration only.
Adverse Reactions:
- Common Adverse Reactions: Hypertriglyceridemia, hypercholesterolemia, elevated alanine aminotransferase (ALT), and elevated aspartate aminotransferase (AST).
- Serious Adverse Reactions: No treatment-related SAEs were observed in Phase III studies compared to controls (e.g., betamethasone or NSAIDs). Overall SAEs were low (0.6% in Firsekibart group vs. 3.8% in control).
Contraindications: Hypersensitivity to the active ingredient or any excipients. Use with caution or contraindicate during pregnancy.
Precautions:
- Use with caution in patients with active infections, history of recurrent infections, or high infection risk. Assess for active and latent tuberculosis before treatment. Not recommended with TNF inhibitors. Avoid live or attenuated vaccines during treatment; no data on inactivated vaccines.

Firsekibart For Injection Interactions

No formal drug-drug interaction studies conducted. In vitro, Firsekibart (2.00-200 μg/mL) may modulate IL-1β’s inhibitory effects on CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in hepatocytes. This could affect CYP450 substrates with narrow therapeutic indices requiring individualized dosing. Monitor efficacy and concentrations of such drugs when initiating Firsekibart, and adjust doses as needed.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.