Peringatan Keamanan

There is limited information regarding the acute toxicity (LD50) and overdosage of natalizumab. The safety of doses higher than 300 mg has not been adequately evaluated. The maximum amount of natalizumab that can be safely administered has not been determined.L48031

Natalizumab

DB00108

biotech approved investigational

Deskripsi

Natalizumab is a recombinant humanized IgG4? monoclonal antibody that binds to ?4-integrin.L48041 While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML). In 2006, the FDA reintroduced the drug to the market for multiple sclerosis.A261326 Natalizumab was further approved by the FDA for the treatment of Crohn's Disease in January 2008.A261331

On August 24, 2023, the first biosimilar to natalizumab, natalizumab-sztn, was approved by the FDA.L48041 Natalizumab was approved by the European Commission on September 22, 2023.L49096

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) Following the repeat intravenous administration of a 300 mg dose of natalizumab in patients with multiple sclerosis, the mean ± SD half-life was 11 ± 4 days. In patients with Crohn's Disease, it was 10 ± 7 days.[L48031]
Volume Distribusi Following the repeat intravenous administration of a 300 mg dose of natalizumab in patients with multiple sclerosis, the mean ± SD volume of distribution was 5.7 ± 1.9 L. In patients with Crohn's Disease, it was 5.2 ± 2.8 L.[L48031]
Klirens (Clearance) Following the repeat intravenous administration of a 300 mg dose of natalizumab in patients with multiple sclerosis, the mean ± SD clearance was 16 ± 5 mL/hour. In patients with Crohn's Disease, it was 22 ± 22 mL/hour.[L48031] Natalizumab clearance increased with body weight in a less-than-proportional manner. The presence of persistent anti-natalizumab antibodies increased natalizumab clearance approximately 3-fold.

Absorpsi

Following the repeat intravenous administration of a 300 mg dose of natalizumab in patients with multiple sclerosis, the mean ± SD maximum observed serum concentration was 110 ± 52 mcg/mL. Mean average steady-state trough concentrations ranged from 23 mcg/mL to 29 mcg/mL. The observed time to steady-state was approximately 24 weeks after every four weeks of dosing.L48031 In patients with Crohn's Disease, the mean ± SD maximum observed serum concentration was 101 ± 34 mcg/mL. The mean ± SD average steady-state trough concentration was 10 ± 9 mcg/mL. The estimated time to steady-state was approximately 16 to 24 weeks after every four weeks of dosing. L48031

Metabolisme

No information is available.

Rute Eliminasi

No information is available.

Interaksi Obat

672 Data
Denosumab The risk or severity of immunosuppression can be increased when Denosumab is combined with Natalizumab.
Etanercept The risk or severity of immunosuppression can be increased when Etanercept is combined with Natalizumab.
Peginterferon alfa-2a The risk or severity of immunosuppression can be increased when Peginterferon alfa-2a is combined with Natalizumab.
Interferon alfa-n1 The risk or severity of immunosuppression can be increased when Interferon alfa-n1 is combined with Natalizumab.
Interferon alfa-n3 The risk or severity of immunosuppression can be increased when Interferon alfa-n3 is combined with Natalizumab.
Peginterferon alfa-2b The risk or severity of immunosuppression can be increased when Peginterferon alfa-2b is combined with Natalizumab.
Anakinra The risk or severity of immunosuppression can be increased when Anakinra is combined with Natalizumab.
Interferon gamma-1b The risk or severity of immunosuppression can be increased when Interferon gamma-1b is combined with Natalizumab.
Interferon alfa-2a The risk or severity of immunosuppression can be increased when Interferon alfa-2a is combined with Natalizumab.
Aldesleukin The risk or severity of immunosuppression can be increased when Aldesleukin is combined with Natalizumab.
Adalimumab The risk or severity of immunosuppression can be increased when Adalimumab is combined with Natalizumab.
Gemtuzumab ozogamicin The risk or severity of immunosuppression can be increased when Gemtuzumab ozogamicin is combined with Natalizumab.
Pegaspargase The risk or severity of immunosuppression can be increased when Pegaspargase is combined with Natalizumab.
Infliximab The risk or severity of immunosuppression can be increased when Infliximab is combined with Natalizumab.
Interferon beta-1b The risk or severity of immunosuppression can be increased when Interferon beta-1b is combined with Natalizumab.
Interferon alfacon-1 The risk or severity of immunosuppression can be increased when Interferon alfacon-1 is combined with Natalizumab.
Trastuzumab The risk or severity of immunosuppression can be increased when Trastuzumab is combined with Natalizumab.
Rituximab The risk or severity of immunosuppression can be increased when Rituximab is combined with Natalizumab.
Basiliximab The risk or severity of immunosuppression can be increased when Basiliximab is combined with Natalizumab.
Muromonab The risk or severity of immunosuppression can be increased when Muromonab is combined with Natalizumab.
Ibritumomab tiuxetan The risk or severity of immunosuppression can be increased when Ibritumomab tiuxetan is combined with Natalizumab.
Tositumomab The risk or severity of immunosuppression can be increased when Tositumomab is combined with Natalizumab.
Alemtuzumab The risk or severity of immunosuppression can be increased when Alemtuzumab is combined with Natalizumab.
Alefacept The risk or severity of immunosuppression can be increased when Alefacept is combined with Natalizumab.
Efalizumab The risk or severity of immunosuppression can be increased when Efalizumab is combined with Natalizumab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of immunosuppression can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Natalizumab.
Interferon alfa-2b The risk or severity of immunosuppression can be increased when Interferon alfa-2b is combined with Natalizumab.
Daclizumab The risk or severity of immunosuppression can be increased when Daclizumab is combined with Natalizumab.
Phenylalanine The risk or severity of immunosuppression can be increased when Phenylalanine is combined with Natalizumab.
Flunisolide The risk or severity of immunosuppression can be increased when Flunisolide is combined with Natalizumab.
Bortezomib The risk or severity of immunosuppression can be increased when Bortezomib is combined with Natalizumab.
Cladribine The risk or severity of immunosuppression can be increased when Cladribine is combined with Natalizumab.
Carmustine The risk or severity of immunosuppression can be increased when Carmustine is combined with Natalizumab.
Amsacrine The risk or severity of immunosuppression can be increased when Amsacrine is combined with Natalizumab.
Bleomycin The risk or severity of immunosuppression can be increased when Bleomycin is combined with Natalizumab.
Chlorambucil The risk or severity of immunosuppression can be increased when Chlorambucil is combined with Natalizumab.
Raltitrexed The risk or severity of immunosuppression can be increased when Raltitrexed is combined with Natalizumab.
Mitomycin The risk or severity of immunosuppression can be increased when Mitomycin is combined with Natalizumab.
Bexarotene The risk or severity of immunosuppression can be increased when Bexarotene is combined with Natalizumab.
Vindesine The risk or severity of immunosuppression can be increased when Vindesine is combined with Natalizumab.
Floxuridine The risk or severity of immunosuppression can be increased when Floxuridine is combined with Natalizumab.
Indomethacin The risk or severity of immunosuppression can be increased when Indomethacin is combined with Natalizumab.
Tioguanine The risk or severity of immunosuppression can be increased when Tioguanine is combined with Natalizumab.
Vinorelbine The risk or severity of immunosuppression can be increased when Vinorelbine is combined with Natalizumab.
Dexrazoxane The risk or severity of immunosuppression can be increased when Dexrazoxane is combined with Natalizumab.
Beclomethasone dipropionate The risk or severity of immunosuppression can be increased when Beclomethasone dipropionate is combined with Natalizumab.
Sorafenib The risk or severity of immunosuppression can be increased when Sorafenib is combined with Natalizumab.
Streptozocin The risk or severity of immunosuppression can be increased when Streptozocin is combined with Natalizumab.
Trifluridine The risk or severity of immunosuppression can be increased when Trifluridine is combined with Natalizumab.
Gemcitabine The risk or severity of immunosuppression can be increased when Gemcitabine is combined with Natalizumab.
Betamethasone The risk or severity of immunosuppression can be increased when Betamethasone is combined with Natalizumab.
Teniposide The risk or severity of immunosuppression can be increased when Teniposide is combined with Natalizumab.
Epirubicin The risk or severity of immunosuppression can be increased when Epirubicin is combined with Natalizumab.
Chloramphenicol The risk or severity of immunosuppression can be increased when Chloramphenicol is combined with Natalizumab.
Lenalidomide The risk or severity of immunosuppression can be increased when Lenalidomide is combined with Natalizumab.
Altretamine The risk or severity of immunosuppression can be increased when Altretamine is combined with Natalizumab.
Zidovudine The risk or severity of immunosuppression can be increased when Zidovudine is combined with Natalizumab.
Cisplatin The risk or severity of immunosuppression can be increased when Cisplatin is combined with Natalizumab.
Oxaliplatin The risk or severity of immunosuppression can be increased when Oxaliplatin is combined with Natalizumab.
Cyclophosphamide The risk or severity of immunosuppression can be increased when Cyclophosphamide is combined with Natalizumab.
Vincristine The risk or severity of immunosuppression can be increased when Vincristine is combined with Natalizumab.
Fluorouracil The risk or severity of immunosuppression can be increased when Fluorouracil is combined with Natalizumab.
Propylthiouracil The risk or severity of immunosuppression can be increased when Propylthiouracil is combined with Natalizumab.
Pentostatin The risk or severity of immunosuppression can be increased when Pentostatin is combined with Natalizumab.
Methotrexate The risk or severity of immunosuppression can be increased when Methotrexate is combined with Natalizumab.
Carbamazepine The risk or severity of immunosuppression can be increased when Carbamazepine is combined with Natalizumab.
Vinblastine The risk or severity of immunosuppression can be increased when Vinblastine is combined with Natalizumab.
Fluticasone propionate The risk or severity of immunosuppression can be increased when Fluticasone propionate is combined with Natalizumab.
Fluocinolone acetonide The risk or severity of immunosuppression can be increased when Fluocinolone acetonide is combined with Natalizumab.
Linezolid The risk or severity of immunosuppression can be increased when Linezolid is combined with Natalizumab.
Imatinib The risk or severity of immunosuppression can be increased when Imatinib is combined with Natalizumab.
Triamcinolone The risk or severity of immunosuppression can be increased when Triamcinolone is combined with Natalizumab.
Clofarabine The risk or severity of immunosuppression can be increased when Clofarabine is combined with Natalizumab.
Prednisone The risk or severity of immunosuppression can be increased when Prednisone is combined with Natalizumab.
Pemetrexed The risk or severity of immunosuppression can be increased when Pemetrexed is combined with Natalizumab.
Fludrocortisone The risk or severity of immunosuppression can be increased when Fludrocortisone is combined with Natalizumab.
Mycophenolate mofetil The risk or severity of immunosuppression can be increased when Mycophenolate mofetil is combined with Natalizumab.
Daunorubicin The risk or severity of immunosuppression can be increased when Daunorubicin is combined with Natalizumab.
Hydrocortisone The risk or severity of immunosuppression can be increased when Hydrocortisone is combined with Natalizumab.
Irinotecan The risk or severity of immunosuppression can be increased when Irinotecan is combined with Natalizumab.
Methimazole The risk or severity of immunosuppression can be increased when Methimazole is combined with Natalizumab.
Etoposide The risk or severity of immunosuppression can be increased when Etoposide is combined with Natalizumab.
Sulfasalazine The risk or severity of immunosuppression can be increased when Sulfasalazine is combined with Natalizumab.
Dacarbazine The risk or severity of immunosuppression can be increased when Dacarbazine is combined with Natalizumab.
Temozolomide The risk or severity of immunosuppression can be increased when Temozolomide is combined with Natalizumab.
Penicillamine The risk or severity of immunosuppression can be increased when Penicillamine is combined with Natalizumab.
Prednisolone The risk or severity of immunosuppression can be increased when Prednisolone is combined with Natalizumab.
Tacrolimus The risk or severity of immunosuppression can be increased when Tacrolimus is combined with Natalizumab.
Sirolimus The risk or severity of immunosuppression can be increased when Sirolimus is combined with Natalizumab.
Mechlorethamine The risk or severity of immunosuppression can be increased when Mechlorethamine is combined with Natalizumab.
Azacitidine The risk or severity of immunosuppression can be increased when Azacitidine is combined with Natalizumab.
Carboplatin The risk or severity of immunosuppression can be increased when Carboplatin is combined with Natalizumab.
Methylprednisolone The risk or severity of immunosuppression can be increased when Methylprednisolone is combined with Natalizumab.
Dactinomycin The risk or severity of immunosuppression can be increased when Dactinomycin is combined with Natalizumab.
Cytarabine The risk or severity of immunosuppression can be increased when Cytarabine is combined with Natalizumab.
Azathioprine The risk or severity of immunosuppression can be increased when Azathioprine is combined with Natalizumab.
Doxorubicin The risk or severity of immunosuppression can be increased when Doxorubicin is combined with Natalizumab.
Hydroxyurea The risk or severity of immunosuppression can be increased when Hydroxyurea is combined with Natalizumab.
Busulfan The risk or severity of immunosuppression can be increased when Busulfan is combined with Natalizumab.
Mycophenolic acid The risk or severity of immunosuppression can be increased when Mycophenolic acid is combined with Natalizumab.

Target Protein

Integrin alpha-4 ITGA4
Low affinity immunoglobulin gamma Fc region receptor III-B FCGR3B
High affinity immunoglobulin gamma Fc receptor I FCGR1A
Intercellular adhesion molecule 1 ICAM1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 28721050
    Brandstadter R, Katz Sand I: The use of natalizumab for multiple sclerosis. Neuropsychiatr Dis Treat. 2017 Jun 28;13:1691-1702. doi: 10.2147/NDT.S114636. eCollection 2017.
  • PMID: 30480940
    Babaesfahani A, Khanna NR, Kuns B: Natalizumab. .
  • PMID: 12510039
    Ghosh S, Goldin E, Gordon FH, Malchow HA, Rask-Madsen J, Rutgeerts P, Vyhnalek P, Zadorova Z, Palmer T, Donoghue S: Natalizumab for active Crohn's disease. N Engl J Med. 2003 Jan 2;348(1):24-32.
  • PMID: 21975773
    Pucci E, Giuliani G, Solari A, Simi S, Minozzi S, Di Pietrantonj C, Galea I: Natalizumab for relapsing remitting multiple sclerosis. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD007621. doi: 10.1002/14651858.CD007621.pub2.
  • PMID: 21960916
    Dryden GW: Natalizumab for Moderate-to-Severe Crohn's Disease. Gastroenterol Hepatol (N Y). 2008 Apr;4(4):296.

Contoh Produk & Brand

Produk: 6 • International brands: 1
Produk
  • Tyruko
    - • 300 mg • Intravenous • EU • Approved
  • Tysabri
    Injection • 300 mg/15mL • Intravenous • US • Approved
  • Tysabri
    Injection • 300 mg/15mL • Intravenous • US • Approved
  • Tysabri
    Solution • 300 mg / 15 mL • Intravenous • Canada • Approved
  • Tysabri
    Injection, solution, concentrate • 300 mg • Intravenous • EU • Approved
  • Tysabri
    Injection, solution, concentrate • 150 mg • Intravenous • EU • Approved
International Brands
  • Antegren

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