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Mepolizumab

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
Severe eosinophilic asthma
Adult: As an adjunctive treatment for refractory cases: 100 mg once every 4 weeks. Assess the need for continued therapy at least annually based on patient's disease severity and level of control of exacerbations.
Child: 6-11 years As an adjunctive treatment for refractory cases: 40 mg once every 4 weeks; ≥12 years Same as adult dose.

Subcutaneous
Chronic rhinosinusitis with nasal polyps
Adult: As an adjunctive treatment to intranasal corticosteroids for cases in which systemic corticosteroids and/or surgery can not provide adequate disease control: 100 mg once every 4 weeks.

Subcutaneous
Eosinophilic granulomatosis with polyangiitis
Adult: As an adjunctive treatment for relapsing-remitting or refractory cases: 300 mg (3 separate 100 mg inj, each inj site is separated by at least 5 cm) once every 4 weeks. Assess the need for continued therapy at least annually based on patient's disease severity and improvement of symptom control.

Subcutaneous
Hypereosinophilic syndrome
Adult: As adjunctive treatment for inadequately controlled cases without an identifiable non-haematologic secondary cause: 300 mg (3 separate 100 mg inj, each inj site is separated by at least 5 cm) once every 4 weeks. Assess the need for continued therapy at least annually based on patient's disease severity and improvement of symptom control.
Child: ≥12 years Same as adult dose.
Hướng dẫn pha thuốc
Lyophilised powder for inj: Reconstitute vial with 1.2 mL sterile water for inj to yield a final concentration of 100 mg/mL. Direct the stream of the diluent vertically onto the middle of the lyophilised cake. Dissolve the powder by gently swirling the vial for 10 seconds with a circular motion at intervals of 15 seconds, typically within 5 minutes. Do not shake.
Chống chỉ định
Hypersensitivity.
Thận trọng
Patient with parasitic/helminth infection. Not indicated for the treatment of acute asthma symptoms or exacerbations (including status asthmaticus). Children. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Acute and delayed systemic reactions including hypersensitivity (e.g. urticaria, rash, anaphylaxis, angioedema, bronchospasm, hypotension); asthma-related adverse symptoms or exacerbations, herpes zoster infection.
Gastrointestinal disorders: Upper abdominal pain.
General disorders and administration site conditions: Fever, fatigue, local inj site reactions (e.g. burning sensation, erythema, itching, pain, swelling), systemic non-allergic administration-related reactions (e.g. flushing, myalgia, rash).
Musculoskeletal and connective tissue disorders: Back pain, arthralgia, muscle spasms.
Nervous system disorders: Headache.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Lower respiratory tract infection, pharyngitis, nasal congestion, oropharyngeal pain.
Skin and subcutaneous tissue disorders: Eczema.
Chỉ số theo dõi
Monitor pulmonary function tests (e.g. peak flow, FEV1). Assess for signs of hypersensitivity reactions (including delayed reactions). Monitor for marker of deteriorating asthma condition (i.e. increased use of short-acting β2-agonist inhalers).
Tác dụng
Description:
Mechanism of Action: Mepolizumab is a humanised monoclonal antibody (IgG1 kappa) that selectively binds to human interleukin-5 (IL-5) and inhibits its binding to the α chain of the IL-5 receptor complex expressed on the surface of eosinophils. This action results in reduced production and survival of eosinophils and decreased eosinophil-mediated inflammation.
Pharmacokinetics:
Absorption: Bioavailability: 74-80%. Time to peak plasma concentration: 4-8 days.
Distribution: Volume of distribution: Approx 3.6 L.
Metabolism: Degraded by proteolytic enzymes that are widely distributed in the body and not limited to hepatic tissue.
Excretion: Terminal elimination half-life: 16-22 days.
Bảo quản
Pre-filled syringe/autoinjector: Store between 2-8°C. Do not freeze. If needed, may store unopened cartons at room temperature (up to 30°C) for up to 7 days. Protect from light and heat. Do not shake. Unopened vial: Store between 2-8°C or below 25°C. Do not freeze. Protect from light. Reconstituted vials: Use immediately; if necessary, may store below 30°C for up to 8 hours. Do not freeze.
Phân loại MIMS
Thuốc trị hen & bệnh phổi tắc nghẽn mạn tính
Phân loại ATC
R03DX09 - mepolizumab ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.
Tài liệu tham khảo
Anon. Mepolizumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/12/2022.

Anon. Mepolizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/12/2022.

Buckingham R (ed). Mepolizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/12/2022.

GlaxoSmithKline NZ Limited. Nucala Powder for Injection and Solution for Injection data sheet 5 October 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 13/12/2022.

Joint Formulary Committee. Mepolizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/12/2022.

Nucala 100 mg Solution for Injection in Pre-filled Syringe (GlaxoSmithKline UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 13/12/2022.

Nucala 100 mg/mL Solution for Injection in Pre-filled Pen; Solution for Injection in Pre-filled Syringe (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 13/12/2022.

Nucala Injection, Powder, for Solution; Injection, Solution (GlaxoSmithKline LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/12/2022.

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