Secukinumab Instructions

1. Generic name: secukinumab

Product name: Cosentyx, Verxant

All names: Secukinumab, Secukinumab, Cosentyx, Secukinumab

2. Indications:

1. Plaque psoriasis: Secukinumab ( Secukinumab) is suitable for the treatment of patients with moderate to severe plaque psoriasis aged 6 years and above who require systemic therapy or phototherapy.

2. Psoriatic arthritis(PsA):Secukinumab is suitable for the treatment of active psoriatic arthritis in patients 2 years old and above.

3. Ankylosing spondylitis (AS): Secukinumab is suitable for the treatment of adult patients with active ankylosing spondylitis.

4. Non-radiographic axial spondyloarthritis (nr-axSpA): Secukinumab is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

5. Enthesitis-related arthritis (ERA): Secukinumab is suitable for the treatment of active enthesitis-related arthritis in patients 4 years of age and older.

3. Usage and dosage:

1. Before taking secukinumab: Assess the patient's tuberculosis infection status before starting to take secukinumab, and complete all age-appropriate vaccinations in accordance with the recommendations of current immunization guidelines.

2. Recommended dosage:

(1)Plaque psoriasis:

The recommended dose of secukinumab in adults with plaque psoriasis is 300 mg subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Each 300 mg dose is given as one subcutaneous injection of 300 mg or two subcutaneous injections of 150 mg. For some patients, a dose of 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter may be acceptable.

In pediatric patients 6 years of age and older with plaque psoriasis, the recommended weight-based dosage is administered by subcutaneous injection at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. The recommended dose for patients weighing <50 kg (at time of administration) is 75 mg, and for patients ≥50 kg (at time of administration), the recommended dose is 150 kg.

（2）Psoriatic arthritis (PsA):

The recommended dose of secukinumab for adults with PsA and moderate to severe plaque psoriasis is 300 mg, an injectable dose similar to that for plaque psoriasis. For other adult patients withPsA, secukinumab may be given by subcutaneous injection with or without a loading dose of 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter, and a no-loading dose of 150 mg every 4 weeks. If the patient continues to have active PsA, consider a dose of 300 mg subcutaneously every 4 weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or two subcutaneous injections of 150 mg.

Administer the recommended weight-based dose by subcutaneous injection to pediatric patients 2 years and older with PsA at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. The recommended dose is 75mg for patients ≥15kgand<50kg and 150mg for patients ≥50kg. Can be used in combination with methotrexate or alone.

(3) Ankylosing Spondylitis (AS): Loading dose of 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter, and no loading dose of 150 mg every 4 weeks. If the patient continues to have active AS, consider subcutaneous injection of 300 mg every 4 weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or two subcutaneous injections of 150 mg.

(4) Nonradiographic axial spondyloarthritis (nr-axSpA): Loading dose of 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter, no loading dose of 150 mg every 4 weeks.

(5) Enthesitis-associated arthritis (ERA): The recommended body weight dose for ERA in pediatric patients 4 years and older is administered by subcutaneous injection at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter, and the recommended dose is 75 mg for patients ≥15 kg and <50 kg and 150 mg for patients ≥50 kg.

4. Adverse reactions:

Very common (more than 10% of people experience it) side effects include upper respiratory tract infection, Common(experienced by 1 to 10 percent of people) include oral herpes, runny nose, and diarrhea. In clinical trials, rare cases of allergic reactions, serious infections, and some serious inflammatory bowel disease occurred, some of which were new and some of which were worsening of existing conditions. Adverse reactions experienced post-marketing include skin and subcutaneous tissue disorders such as eczematous rashes (atopic dermatitis-like rash, dyshidrotic eczema, and erythroderma).

5. Storage:

Refrigerate secukinumab at 2°C to 8°C (36°F to 46°F). Store product in original carton away from light until time of use. Do not freeze. To avoid foaming, do not shake. Store at room temperature not exceeding 30°C (86°F) for up to 4 days. If stored outside the refrigerator for more than 4 days, discard. Return to the refrigerator only once and must be stored at 2°C to 8°C (36°F to 46°F) until use or expiration date.

6. Taboo:

Secukinumab is contraindicated in patients with severe allergic reactions to secukinumab or any of the excipients in secukinumab. Cases of anaphylaxis have been reported during treatment with secukinumab.

7. Mechanism of action:

Secukinumab is a humanIgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

Secukinumab The original drug has been launched in China and has entered the scope of Class B medical insurance. However, domestic patients who can purchase this drug are limited to eligible patients with psoriasis and ankylosing spondylitis. Patients who are not eligible for medical insurance reimbursement can only purchase it at their own expense. The price of each box of 150mg/ML is about RMB 1,000. SecukinumabThe original drug has also been launched overseas. The specifications of the Turkish original versionThe price per box of 150mg/ML is about 1,500 yuan, and the European version is 150m. The price of each box of g/ML*2 is around RMB 15,000 (the price may fluctuate due to the exchange rate). The ingredients of foreign original drugs and domestic original drugs are basically the same. Currently, there are no generic secukinumab drugs on the market.