Xeligekimab(赛立奇单抗注射液)

Introduction of Xeligekimab

The launch of Xeligekimab Injection has greatly enhanced the accessibility and cost-effectiveness of domestic innovative biological products, providing a high-quality option for long-term standardized treatment to patients with autoimmune diseases.

Indication

This product is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy.

Overview

Dosage and Administration

This product should be used under the guidance and supervision of physicians experienced in the diagnosis and treatment of the indications for this product.

Dosage

Psoriasis

The recommended dose of this product is 200 mg per administration, to be given at Weeks 0, 2, 4, 6, 8, 10 and 12 respectively, followed by administration once every 4 weeks thereafter.

The 200 mg dose should be administered as two separate injections of 100mg each.

Administration Method

This product should be administered by subcutaneous injection. If possible, injection should be avoided at the psoriatic lesion sites.

Upon approval by healthcare professionals, patients may self-administer this product after receiving training on subcutaneous injection techniques. Physicians shall ensure appropriate follow-up of patients and provide guidance on product use. A comprehensive administration guide is included in the package insert.

Contraindications

Patients with severe hypersensitivity to serelizumab or any of its excipients.

Active infections of clinically significant importance (e.g., active tuberculosis).

Adverse Reactions

The most commonly reported adverse drug reactions (ADR) are upper respiratory tract infections and injection site reactions.

Use in Special Populations

Pregnancy and Lactation

Pregnancy

There are currently no clinical data on the use of this product in pregnant women. Animal studies have not found any direct or indirect adverse effects of the murine analog of serelizumab on pregnancy or fetal development.

However, animal reproductive studies do not fully predict human responses, so it is advisable to avoid the use of this product during pregnancy.

Lactation

It is currently unknown whether serelizumab is secreted in human milk or absorbed systemically after ingestion.

Animal experiments showed that low levels of the murine analog of serelizumab were detected in the milk of ICR mice. In addition, based on the fact that immunoglobulins can be secreted in breast milk,

lactating women should use this product with caution.

Fertility

The effect of serelizumab on human fertility is currently unknown. Animal studies have not found any direct or indirect adverse effects of the murine analog of serelizumab on fertility.

Pediatric Use

The safety and efficacy of this product in patients under 18 years of age have not been established.

Geriatric Use

No dosage adjustment is required.

For more detailed drug information, please consult the official package leaflet.

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