Thông tin thuốc của Guselkumab

Thông tin này không áp dụng cho tất cả các quốc gia. Vui lòng tham khảo thông tin kê toa lưu hành tại Việt Nam.

Thông tin thuốc gốc

Chỉ định và Liều dùng

Subcutaneous
Plaque psoriasis

Adult: Moderate to severe cases in patients who are candidates for systemic therapy or phototherapy: Initially, 100 mg at weeks 0 and 4, followed by a maintenance dose of 100 mg every 8 weeks. Consider treatment discontinuation if there is no response after 16 weeks.

Subcutaneous
Psoriatic arthritis

Adult: As monotherapy or in combination with methotrexate in patients who had an inadequate response or are intolerant to a previous disease-modifying antirheumatic drugs (DMARDs) therapy: Initially, 100 mg at weeks 0 and 4, followed by a maintenance dose of 100 mg every 8 weeks. In patients who are at high risk for joint damage: 100 mg every 4 weeks may be considered. Consider treatment discontinuation if there is no response after 24 weeks.

Chống chỉ định

Hypersensitivity. Clinically important active infections (e.g. active TB). Concurrent administration of live vaccines.

Thận trọng

Patient with history of chronic or recurrent infections; history of latent or active TB with unconfirmed adequate course of TB treatment. Pregnancy and lactation.

Tác dụng không mong muốn

Significant: Serious hypersensitivity reactions, including anaphylaxis, dyspnoea and urticaria; increased risk of infections (e.g. upper respiratory tract infections, gastroenteritis, tinea infections, herpes simplex infections), antibody formation; elevated hepatic transaminase (in patients receiving every 4 weeks doses for psoriatic arthritis).
Gastrointestinal disorders: Diarrhoea.
General disorders and administration site conditions: Inj site reactions (e.g. erythema, pain, swelling, pruritus, bruising).
Investigations: Decreased neutrophil count.
Musculoskeletal and connective tissue disorders: Arthralgia.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Bronchitis.
Skin and subcutaneous tissue disorders: Rash.

Chỉ số theo dõi

Evaluate for TB infection prior to initiation and periodically during treatment. Perform hepatitis B virus (HBV) or hepatitis C virus screening before starting therapy in all patients, and for HBV carriers during and several months after treatment; HIV screening in high-risk patients prior to therapy initiation. Obtain CBC with differential and complete metabolic panel at baseline; liver enzymes at baseline and regularly thereafter (in patients receiving every 4 weeks doses for psoriatic arthritis). Closely monitor for signs and symptoms of infection and active TB during and after treatment.

Tương tác

Potentially Fatal: May enhance adverse or toxic effects of live vaccines.

Tác dụng

Description:
Mechanism of Action: Guselkumab is a recombinant human immunoglobulin G₁ lambda (IgG₁ lambda) monoclonal antibody. It selectively binds to the p19 subunit of interleukin-23 (IL-23), a cytokine involved in the normal inflammatory and immune responses, thereby inhibiting the release of proinflammatory cytokines and chemokines.
Pharmacokinetics:
Absorption: Bioavailability: Approx 49%. Time to peak plasma concentration: 5.5 days.
Distribution: Volume of distribution: 13.5 L.
Metabolism: Degraded via catabolic pathways into small peptides and amino acids.
Excretion: Elimination half-life: Approx 15-18 days.

Bảo quản

Store between 2-8°C. Do not freeze. Protect from light. Do not shake.

Phân loại MIMS

Thuốc ức chế miễn dịch / Thuốc trị vẩy nến, tăng tiết bã nhờn & vảy cá

Phân loại ATC

L04AC16 - guselkumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.

Tài liệu tham khảo

Anon. Guselkumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/05/2022.

Anon. Guselkumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/05/2022.

Buckingham R (ed). Guselkumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/05/2022.

Joint Formulary Committee. Guselkumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/05/2022.

Tremfya (Johnson & Johnson Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/05/2022.

Tremfya 100 mg Solution for Injection in Pre-filled Pen (Janssen-Cilag Limited). MHRA. https://products.mhra.gov.uk.

Tremfya Injection (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/05/2022.

Thông báo miễn trừ trách nhiệm: Thông tin này được MIMS biên soạn một cách độc lập dựa trên thông tin của Guselkumab từ nhiều nguồn tài liệu tham khảo và được cung cấp chỉ cho mục đích tham khảo. Việc sử dụng điều trị và thông tin kê toa có thể khác nhau giữa các quốc gia. Vui lòng tham khảo thông tin sản phẩm trong MIMS để biết thông tin kê toa cụ thể đã qua phê duyệt ở quốc gia đó. Mặc dù đã rất nỗ lực để đảm bảo nội dung được chính xác nhưng MIMS sẽ không chịu trách nhiệm hoặc nghĩa vụ pháp lý cho bất kỳ yêu cầu bồi thường hay thiệt hại nào phát sinh do việc sử dụng hoặc sử dụng sai các thông tin ở đây, về nội dung thông tin hoặc về sự thiếu sót thông tin, hoặc về thông tin khác. © 2024 MIMS. Bản quyền thuộc về MIMS. Phát triển bởi MIMS.com