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Belimumab

Brand and Other Names: Benlysta
Mechanism of Action:

BENLYSTA is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. BENLYSTA does not bind B cells directly, but by binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. 

Indications:

BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy.


Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is is notrecommended in these situations. 

Route: Intravenous
Dose:
  • Recommended dosage regimen is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Reconstitute, dilute and administer as an intravenous infusion only, over a period of 1 hour.
  • Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions
Adverse Reactions:

Common adverse reactions (5%) in clinical trials were: nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

Contraindication:

Previous anaphylaxis to belimumab.

Warnings and Precautions:
  • Mortality: There were more deaths reported with BENLYSTA than with placebo during the controlled period of clinical trials.
  • Serious Infections: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. Use with caution in patients with chronic infections. Consider interrupting BENLYSTA therapy if patients develop a new infection during BENLYSTA treatment.
  • Hypersensitivity Reactions, Including Anaphylaxis: Serious and fatal reactions have been reported. BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis. Monitor patients during and for an appropriate period of time after administration of BENLYSTA.
  • Depression: Depression and suicidality have been reported in BENLYSTA studies. Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes.
  • Immunization: Live vaccines should not be given concurrently with BENLYSTA. 
See package insert for full prescribing information.