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belimumab (Benlysta)

Indications: - treatment of patients with systemic lupus erythematosus already on standard treatment [1] - lupus nephritis Contraindications: Pregnancy category: C [3] Epidemiology: - may not be effective in people of African descent Dosage: - 10 mg/kg given as an IV infusion on study days 0, 14, & 28 then every 4 weeks thereafter for a total of 48 weeks [2] Monitor: - CBC, basic metabolic panel, LFTs, serum IgG at baseline, at 2 weeks, & every 3 months thereafter [3] Adverse effects: - risk of infection - increased mortality Mechanism of action: - human monoclonal antibody that targets the B-lymphocyte stimulator protein (TNFSF13B, BLyS, BAFF) Notes: - costs at least $35,000 per year (2011) [2] - self-injectable belimumab (Benlysta) for SLE FDA-approved July 2017 Management: - whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent [3]

Interactions

drug adverse effects of immunosuppressive agents monitor with immunosuppressive agents

General

biologic immunosuppressive agent (biologic agent, biologic immune modulator) pharmaceutical monoclonal antibody

References

  1. FDA NEWS RELEASE: March 9, 2011 FDA approves Benlysta to treat lupus http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246489.htm
  2. Prescriber's Letter 18(5): 2011 Management of Systemic Lupus Erythematosus Detail-Document#: 270512 (subscription needed) http://www.prescribersletter.com
  3. Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19. American College of Physicians, Philadelphia 2012, 2015, 2018, 2022.
  4. Furie R, Petri M, Zamani O et al A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918-30 PMID: 22127708
  5. Brooks M FDA Clears Self-injectable Belimumab (Benlysta) for SLE Medscape - Jul 21, 2017. http://www.medscape.com/viewarticle/883270
  6. Garcia A, De Sanctis JB. A Review of Clinical Trials of Belimumab in the Management of Systemic Lupus Erythematosus. Curr Pharm Des. 2016;22(41):6306-6312. Review. PMID: 27587201