Belimumab


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Systemic lupus erythematosus
Adult: As adjunctive therapy in patient with active, autoantibody-positive cases: Initially, 10 mg/kg via infusion over 60 minutes every 2 weeks for 3 doses, then at 4-week intervals thereafter. Discontinue if no improvement within 6 months of therapy.

Subcutaneous
Systemic lupus erythematosus
Adult: As adjunctive therapy in patient with active, autoantibody-positive cases: 200 mg via injector device once weekly. Discontinue if no improvement within 6 months of therapy.
Hướng dẫn pha thuốc
IV infusion: Add 1.5 or 4.8 mL of sterile water for injection to a vial containing 120 mg or 140 mg, respectively. Gently swirl for 60 seconds every 5 minutes up to 30 minutes until powder has dissolved. Do not shake. Further dilute appropriate volume in 250 mL of NaCl 0.45%, or lactated Ringer’s solution by removing and discarding equal amount of the reconstituted solution to be added. Mix by gentle inversion.
Chống chỉ định
Administration of live vaccines.
Thận trọng
Patient with severe or chronic infections, history of malignancy. Not recommended for use in patient with severe active lupus nephritis and or severe active CNS lupus, HIV, history or current hepatitis B or C, hypogammaglobulinaemia, history of major organ transplant or haematopoietic stem cell/marrow transplant or renal transplant.
Phản ứng phụ
Significant: Risk of malignancy, anxiety depression, mood changes insomnia.
Blood and lymphatic system disorders: Leucopenia.
Gastrointestinal disorders: Nausea, diarrhoea, viral gastroenteritis.
General disorders and administration site conditions: Injection site reactions (e.g. pain, pruritus, erythema, induration, pruritus, haematoma), fever.
Immune system disorders: Hypersensitivity reactions.
Musculoskeletal and connective tissue disorders: Limb pain.
Nervous system disorders: Migraine.
Respiratory, thoracic and mediastinal disorders: Bronchitis, nasopharyngitis, upper respiratory tract infection, pharyngitis.
Potentially Fatal: Anaphylaxis, infusion reactions, severe or chronic infections. CV disease, suicidality, progressive multifocal leucoencephalopathy.
Monitoring Parameters
Monitor for new or worsening of depression, suicidal ideation or other mood changes; hypersensitivity/infusion reactions, infections.
Tương tác
Potentially Fatal: May enhance the adverse/toxic effect of live vaccines.
Tác dụng
Description: Belimumab is a monoclonal antibody that inhibits the binding of B-lymphocyte stimulator protein required to receptors on B-lymphocytes, thereby preventing B-lymphocytes survival and reducing the activity of B-cell mediated immunity and auto-immune response.
Pharmacokinetics:
Absorption: Bioavailability: 74% (SC). Time to peak plasma concentration: 2.6 days (SC).
Distribution: Volume of distribution: 5 L.
Excretion: Terminal elimination half-life: 19.4 days (IV); 18.3 days (SC).
Bảo quản
Store between 2-8°C. Do not freeze. Protect from light. Avoid exposure to heat.
Phân loại MIMS
Phân loại ATC
L04AA26 - belimumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
References
Anon. Belimumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/04/2018.

Anon. Belimumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/04/2018.

Benlysta Injection, Powder, Lyophilized for Solution; Benlysta Solution (Human Genome Sciences, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/04/2018.

Buckingham R (ed). Belimumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/04/2018.

Joint Formulary Committee. Belimumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/04/2018.

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