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Chỉ định và Liều dùng
Intravenous
Relapsing remitting multiple sclerosis Adult: As monotherapy: 300 mg via infusion over 1 hour once every 4 weeks. Discontinue use if no progress is shown after 6 months of treatment. Intravenous Crohn's disease Adult: Moderate to severe, refractory cases: 300 mg via infusion over 1 hour once every 4 weeks. Discontinue use if no progress is shown within 12 weeks upon initiation of treatment.
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Hướng dẫn pha thuốc
Dilute in 100 mL of NaCl 0.9% to a final concentration of 2.6 mg/mL.
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Chống chỉ định
Patient with or with history of progressive multifocal leukoencephalopathy (PML), active malignancies (except cutaneous basal cell carcinoma), active infection. Immunocompromised patients. Concomitant use of immunosuppressants, immunomodulator, antineoplastics, and TNF-α inhibitors.
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Thận trọng
Patient with chronic infections, history of recurring infections and/or underlying conditions that may predispose them to develop infections, presence of anti-JCV antibodies. Hepatic impairment. Pregnancy and lactation.
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Tác dụng không mong muốn
Significant: Hypersensitivity/antibody formation, immune reconstitution inflammatory syndrome (IRIS).
Blood and lymphatic system disorders: Anaemia, hyperbilirubinaemia. GI disorders: Nausea, vomiting, General disorders and admin site conditions: Fatigue. Fever, chills. Immune system disorders: Urticaria. Investigations: Increased ALT/AST. Musculoskeletal and connective tissue disorders: Arthralgia, limb and back pain. Nervous system disorders: Headache, dizziness. Psychiatric disorders: Depression. Renal and urinary disorders: UTI. Resp, thoracic and mediastinal disorders: Upper and lower resp tract infection, nasopharyngitis. Skin and subcutaneous tissue disorders: Rash. Potentially Fatal: Anaphylaxis, hepatotoxicity, herpes infections (e.g. herpes encephalitis and meningitis, acute retinal necrosis; progressive multifocal leukoencephalopathy. |
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Thông tin tư vấn bệnh nhân
This drug may cause dizziness, if affected, do not drive or operate machinery.
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Chỉ số theo dõi
Monitor LFT, eye examination results, and radiographic signs of PML periodically. Perform CBC and anti-JCV antibody testing prior to initiation and periodically during therapy. Monitor for any signs/symptoms of PML during treatment and 6 months after discontinuation and hypersensitivity reactions during and 1 hour after infusion.
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Tương tác
Potentially Fatal: Increased risk of opportunistic infections with immunosuppressants (e.g. 6-mercaptopurine, azathioprine, ciclosporin, methotrexate), immunomodulators (e.g. interferon beta or glatiramer), antineoplastics, and TNF-α inhibitors.
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Tác dụng
Description:
Mechanism of Action: Natalizumab is a recombinant humanised monoclonal antibody that selectively binds to the α-4 integrin molecules. It prevents the migration of leucocytes into the CNS and the gut, thus reducing frequency of relapse, inflammation, and demyelination. Pharmacokinetics: Distribution: Crosses the placenta and enters breast milk. Volume of distribution: Multiple sclerosis: 3.8-7.6 L; Crohn’s disease: 2.4-8 L. Excretion: Elimination half-life: Multiple sclerosis: 7-15 days; Crohn’s disease: 3-17 days. |
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Đặc tính
 Source: National Center for Biotechnology Information. PubChem Database. 189261-10-7, Source=Acorn PharmaTech Product List, SID=329976990, https://pubchem.ncbi.nlm.nih.gov/substance/329976990 (accessed on Jan. 22, 2020) |
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Bảo quản
Store between 2-8°C. Protect from light. Do not freeze.
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Phân loại MIMS
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Phân loại ATC
L04AG03 - natalizumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.
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Tài liệu tham khảo
Anon. Natalizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/01/2018. Buckingham R (ed). Natalizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/01/2018 . Joint Formulary Committee. Natalizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/01/2018 . Rossi S (ed). Natalizumab. Australian Medicines Handbook [online]. Adelaide. Australian Medicines Handbook Pty Ltd. https://amhonline.amh.net.au. Accessed 03/01/2018 . Tysabri 300 mg Concentrate for Solution for Infusion (Biogen Idec Ltd). eMC. https://www.medicines.org.uk/emc/. Accessed 03/01/2018 . Tysabri Injection (Biogen Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/01/2018 .
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