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Benlysta is a prescription biologic containing belimumab, a monoclonal antibody that blocks B-lymphocyte stimulator. It is approved for active systemic lupus erythematosus and active lupus nephritis in patients age 5 and older who are receiving standard therapy. Benlysta is given by intravenous infusion or subcutaneous injection according to age, weight, and condition.
read more about benlysta ...Belimumab binds soluble B-lymphocyte stimulator and blocks its interaction with receptors on B cells. This reduces survival of B cells, including autoreactive B cells, and reduces development of B cells into immunoglobulin-producing plasma cells. Benlysta does not bind directly to B cells.
Benlysta is approved for patients age 5 and older with active systemic lupus erythematosus or active lupus nephritis who are receiving standard therapy. Its efficacy has not been evaluated in severe active central nervous system lupus, and current labeling does not recommend use in that setting.
Intravenous treatment uses 10 mg per kg at two-week intervals for the first three doses, then every four weeks, with each infusion given over one hour. Adults using subcutaneous treatment for active lupus receive 200 mg once weekly. Lupus nephritis uses a higher initial subcutaneous schedule before continuing with 200 mg once weekly. Pediatric dosing is weight based.
Serious risks include infections, progressive multifocal leukoencephalopathy, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, depression, and suicidal thoughts or behavior. Live vaccines are not given at the same time as Benlysta. Prior anaphylaxis, Stevens-Johnson syndrome, or toxic epidermal necrolysis caused by belimumab is a contraindication.
Benlysta treats active systemic lupus erythematosus and active lupus nephritis in patients age 5 and older receiving standard therapy.
Yes. Benlysta comes in intravenous and subcutaneous forms with schedules that differ by age, weight, and condition.
Intravenous doses are given every two weeks for the first three doses and every four weeks afterward.
No. Current labeling states that live vaccines should not be given at the same time as Benlysta.
Belimumab Injection. MedlinePlus. https://medlineplus.gov/druginfo/meds/a611027.html. Date Accessed September 16, 2026.
BENLYSTA (belimumab) Prescribing Information. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG-IFU.PDF. Date Accessed September 16, 2026.
BENLYSTA Frequently Asked Questions. https://www.benlysta.com/resources/faqs/. Date Accessed September 16, 2026.
DailyMed - BENLYSTA (belimumab) injection, powder, lyophilized, for solution and solution. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2fa3c528-1777-4628-8a55-a69dae2381a3. Date Accessed September 16, 2026.
New Drug Therapy Approvals 2022. U.S. Food and Drug Administration. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022. Date Accessed September 16, 2026.