FDA label
What is Benlysta used for?
Benlysta contains belimumab. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “BENLYSTA is indicated for the treatment of patients 5 years of age and older with: Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and; Active lupus nephritis who are receiving standard therapy.”
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Benlysta, injection, powder, lyophilized, for solution
Indications and Usage, quoted from the label by GlaxoSmithKline LLC (BLA125370). Cross-references to other label sections are left out.
BENLYSTA is indicated for the treatment of patients 5 years of age and older with:
- Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and
- Active lupus nephritis who are receiving standard therapy.
Limitations of Use
The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation.
Source: DailyMed label, set id 2fa3c528-1777-4628-8a55-a69dae2381a3, version 38, effective August 21, 2026. NDC 49401-101, one of 2 listings for this product.
Questions
What is Benlysta used for?
The FDA label says: “BENLYSTA is indicated for the treatment of patients 5 years of age and older with: Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and; Active lupus nephritis who are receiving standard therapy.”
What drug class is Benlysta?
FDA lists belimumab in the B Lymphocyte Stimulator-specific Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.