Peringatan Keamanan

There is no LD50 data available for belimumab.

There is limited experience with overdosage of belimumab. Two doses of up to 20 mg/kg have been given intravenously to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.L42630 In the case of inadvertent overdose, patients should be carefully observed and supportive care administered, as appropriateL42705

Belimumab

DB08879

biotech approved

Deskripsi

Belimumab is a fully human recombinant IgG1? monoclonal antibody that inhibits soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B), a B cell survival factor.L42630 BLyS levels are often elevated in immunodeficient and autoimmune disorders, such as systemic lupus erythematosus (SLE).A251495, L42705 By binding to BLyS and blocking its interaction with B cell receptors, belimumab inhibits the survival of B cells. It is produced by recombinant DNA technology in a murine cell (NS0) expression system.L42630

Belimumab was first approved by the FDA on March 9, 2011,A251495 making it the newest drug to be approved for the treatment of SLE in more than 50 years.A251520 It is currently used to treat SLE and lupus nephritis.L42630

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 administration of 10 mg/kg belimumab via intravenous infusion in adults with SLE, the distribution and terminal half-lives were 1.8 days and 19.4 days, respectively. Following subcutaneous administration of 200 mg belimumab once-weekly in adults with SLE, the distribution and terminal half-lives were 1.1 days and 18.3 days, respectively.[L42630]
Volume Distribusi Following administration of 10 mg/kg belimumab via intravenous infusion or 200 mg belimumab once-weekly in adults with SLE, the volume of distribution (V<sub>ss</sub>) was 5 L.[L42630]
Klirens (Clearance) Following administration of 10 mg/kg belimumab via intravenous infusion in adults with SLE, systemic clearance was 215 mL/day. Following subcutaneous administration of 200 mg belimumab once-weekly in adults with SLE, systemic clearance was 204 mL/day.[L42630]

Absorpsi

The absolute bioavailability was 74-82% following single belimumab SC doses in healthy adults.A251500 Following administration of 10 mg/kg belimumab via intravenous infusion in adults with SLE, the Cmax was 313 mcg/mL and the AUC0-? was 3,083 day x mcg/mL. Following subcutaneous administration of 200 mg belimumab once-weekly in adults with SLE, the Cmax was 108 mcg/mL and the AUC0-? was 726 day x mcg/mL.L42630 In healthy Japanese volunteers, the Tmax was 6.5 days after administration of a single subcutaneous dose of 200 mg/mL belimumab.A251505 Steady-state exposure was reached after approximately 11 weeks of subcutaneous administration in healthy subjects of patients with SLE.L42705

Metabolisme

No formal metabolism studies have been conducted. As belimumab is an antibody, it is expected to undergo degradation mediated by proteolytic enzymes to form small peptides and individual amino acids.L42705

Rute Eliminasi

There is no information available.

Interaksi Obat

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

Target Protein

Tumor necrosis factor ligand superfamily member 13B TNFSF13B

Referensi & Sumber

Artikel (PubMed)
  • PMID: 22428610
    Scott LJ, Burness CB, McCormack PL: Belimumab: a guide to its use in systemic lupus erythematosus. BioDrugs. 2012 Jun 1;26(3):195-9. doi: 10.2165/11209060-000000000-00000.
  • PMID: 22231104
    Stohl W, Hilbert DM: The discovery and development of belimumab: the anti-BLyS-lupus connection. Nat Biotechnol. 2012 Jan 9;30(1):69-77. doi: 10.1038/nbt.2076.
  • PMID: 27121939
    Cai WW, Fiscella M, Chen C, Zhong ZJ, Freimuth WW, Subich DC: Bioavailability, Pharmacokinetics, and Safety of Belimumab Administered Subcutaneously in Healthy Subjects. Clin Pharmacol Drug Dev. 2013 Oct;2(4):349-57. doi: 10.1002/cpdd.54. Epub 2013 Aug 26.
  • PMID: 24117862
    Shida Y, Takahashi N, Sakamoto T, Ino H, Endo A, Hirama T: The pharmacokinetics and safety profiles of belimumab after single subcutaneous and intravenous doses in healthy Japanese volunteers. J Clin Pharm Ther. 2014 Feb;39(1):97-101. doi: 10.1111/jcpt.12101. Epub 2013 Oct 5.
  • PMID: 29396833
    Blair HA, Duggan ST: Belimumab: A Review in Systemic Lupus Erythematosus. Drugs. 2018 Mar;78(3):355-366. doi: 10.1007/s40265-018-0872-z.
  • PMID: 35047277
    Shrestha S, Budhathoki P, Adhikari Y, Marasini A, Bhandari S, Mir WAY, Shrestha DB: Belimumab in Lupus Nephritis: A Systematic Review and Meta-Analysis. Cureus. 2021 Dec 15;13(12):e20440. doi: 10.7759/cureus.20440. eCollection 2021 Dec.

Contoh Produk & Brand

Produk: 16 • International brands: 0
Produk
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    Injection, powder, lyophilized, for solution • 400 mg/5mL • Intravenous • US • Approved
  • Benlysta
    Injection, powder, lyophilized, for solution • 120 mg/1.5mL • Intravenous • US • Approved
  • Benlysta
    Injection, powder, lyophilized, for solution • 400 mg/5mL • Intravenous • US • Approved
  • Benlysta
    Injection, powder, lyophilized, for solution • 120 mg/1.5mL • Intravenous • US • Approved
  • Benlysta
    Solution • 200 mg/1mL • Subcutaneous • US • Approved
  • Benlysta
    Powder, for solution • 120 mg / vial • Intravenous • Canada • Approved
  • Benlysta
    Powder, for solution • 400 mg / vial • Intravenous • Canada • Approved
  • Benlysta
    Solution • 200 mg / 1 mL • Subcutaneous • Canada • Approved
Menampilkan 8 dari 16 produk.

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