Instructions for Bimekizumab

1. Name: bimekizumab, bimekizumab, bimekizumab, bimekizumab, Bimzelx

2. Indications:

Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adult patients receiving systemic therapy or phototherapy.

3. Usage and dosage:

1. Before treatment: Before starting treatment with bimezumab, assess the patient's tuberculosis infection; detect liver enzymes, alkaline phosphatase, and bilirubin. Patients should complete all age-appropriate vaccinations as recommended by current immunization guidelines.

2. Recommended dose: At weeks 0, 4, 8, 12 and 16, the recommended dose of bimezumab is 320 mg (subcutaneous injection of 160 mg in 2 doses), and then every 8 weeks. For patients weighing ≥120 kg, consider using 320 mg of bimezumab every 4 weeks after week 16. If you miss a dose, use it as soon as possible. Thereafter, resume dosing at regularly scheduled times.

3. Medication preparation: Before injection, take out the carton containing Bimeizumab from the refrigerator and let it reach room temperature (30 to 45 minutes). There is no need to remove the prefilled syringe or automatic injector from the carton to avoid light. Whenever solution and container permit, visually inspect for particulate matter and discoloration prior to administration. Bimeizhu single injection solution is transparent to slightly milky white, colorless to light brown. Do not use if solution contains visible particles, is discolored, or is cloudy.

4. Medication management: Bimezumab is intended to be used under the guidance and supervision of healthcare professionals. After being trained in subcutaneous injection techniques, patients can inject themselves. Each prefilled syringe or auto-injector of bimekizumab contains 160 mg of bimekizumab-bkzx. For each dose, administer two separate 160 mg single-dose prefilled syringes or auto-injectors subcutaneously at different anatomical locations (e.g., thigh, abdomen, or back of upper arm). Discard syringe or autoinjector after use.

Do not inject bimezumab within 2 inches (5 cm) of your belly button or in areas of skin that are tender, bruised, red, hard, thick, scaly, or affected by psoriasis. Bimezumab should only be used in the upper and outer arms by a health care professional or caregiver. Do not reuse.

4. Adverse reactions:

In clinical studies of bimezumab, common adverse reactions included upper respiratory tract infection, oral candidiasis, headache, injection site reaction, ringworm infection, gastroenteritis, herpes simplex infection, acne, folliculitis, other candida infections, and fatigue.

5. Storage:

Bimezumab is a sterile, preservative-free, clear to slightly opalescent, colorless to light brown injectable solution. Refrigerate the carton containing Bimezumab between 2°C and 8°C (36°F to 46°F). Store product in original carton away from light until use. Do not freeze. Don't shake. Do not use beyond the expiration date. Bimizumab does not contain preservatives, discard any unused portion.

When necessary, bimeclizumab prefilled syringes or auto-injectors can be stored in the original carton at room temperature to 25°C (77°F) for up to 30 days. BimezumabDo not return prefilled syringes or auto-injectors to the refrigerator after storing them at room temperature. Write the date you removed it from the refrigerator in the space provided on the carton, and discard if not used within 30 days.

6. Taboo:

Bimezumab should not be used in patients with severe persistent infection, such as patients with active tuberculosis.

7. Mechanism of action:

Bimezumab is a humanized immunoglobulinIgG1/κ monoclonal antibody, which has two identical antigen-binding regions and selectively binds to human interleukin 17A (IL-17A) , interleukin17F (IL-17F) and interleukin17-AF cytokines, and inhibit their interaction with the IL-17 receptor complex. IL-17A and IL-17F are natural cytokines involved in normal inflammation and immune responses. Bimezumab inhibits the release of proinflammatory cytokines and chemokines.

The generic drug Bimeizumab has not yet been launched in the country, so it cannot be included in medical insurance. The European version of bimezumab original drug sold overseas, specifications160mg*2 per box may cost more than 40,000 yuan (the price may fluctuate due to the exchange rate). The price is still relatively high. There is currently no generic version of bimezumab produced and launched. For the specific price and drug information of this drug, please consult a medical consultant.