Stapokibart Application Scope

Stapokibart is a recombinant humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα). It is used for the treatment of moderate-to-severe atopic dermatitis, chronic rhinosinusitis with nasal polyps (CRSwNP), and seasonal allergic rhinitis in adults.

Stapokibart Characteristics

Ingredients: Active ingredient – Stapokibart (anti–IL-4Rα monoclonal antibody); excipients include sodium acetate, acetic acid, L-arginine hydrochloride, polysorbate 80 (II), and water for injection.
Properties: A colorless to slightly yellow, clear solution for subcutaneous injection.
Packaging Specification: 300 mg (2 mL)/vial, 1 vial per box.
Storage: Store and transport at 2 – 8 °C, protected from light. Do not freeze or shake.
Expiry Date: Refer to packaging.
Executive Standard: NMPA approved (Chinese NDA standard).
Approval Number: NMPA Drug Approval No. S20240040
Date of Revision: September 2024
Manufacturer: Chengdu Keymed Biopharmaceuticals Co., Ltd.

Guidelines for the Use of KEYMEDBIO

Dosage and Administration:
- Recommended Dose:
  - Initial dose: 600 mg (two 300 mg injections)
  - Maintenance dose: 300 mg every two weeks (subcutaneous injection)
- Administration: Inject subcutaneously into the abdomen, thigh, or upper arm. Avoid damaged or scarred skin. Rotate injection sites.
- Missed Dose: If a dose is missed, administer as soon as possible. Resume regular dosing every two weeks thereafter.
Adverse Reactions:
- Common Adverse Reactions: Injection site reactions, mild conjunctivitis, headache, nasopharyngitis.
- Serious Adverse Reactions: Rare hypersensitivity or anaphylactic reactions; conjunctivitis and keratitis requiring ophthalmic evaluation.
Contraindications: Known hypersensitivity to Stapokibart or any component of the formulation.
Precautions:
- Monitor for hypersensitivity during and after injection.
- Avoid use with live or attenuated vaccines during treatment.
- Use with caution in elderly, hepatic, or renal impairment patients.
- For pregnant or lactating women, administer only if the potential benefit justifies the potential risk.
- Do not mix with other drugs in the same syringe or infusion.

Stapokibart Interactions

No known significant drug interactions to date.
Avoid co-administration with live vaccines.

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.