Benlysta
Benlysta ingredients
| Active ingredient | Strength |
|---|---|
| Belimumab | 200 mg/mL, 120 mg/1.5mL, 400 mg/5mL |
What Benlysta is used for
The FDA lists the approved uses on the official label (below). In the EU, belimumab is approved as Benlysta for:
Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Benlysta
- Generic name
- Belimumab
- Made by
- GlaxoSmithKline LLC
- Forms
- Injection, Powder, Lyophilized, For Solution, Solution
- Given
- Intravenous, Subcutaneous
- Drug class
- B Lymphocyte Stimulator-specific Inhibitor
- FDA approval
- Biologic licence (BLA) BLA761043
- On the US market since
- 2011
Official information
- Benlysta prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Belimumab)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Benlysta?
Benlysta (Belimumab) is a specialist medicine made by GlaxoSmithKline LLC, approved by the US FDA.
What are the ingredients of Benlysta?
Benlysta contains Belimumab (200 mg/mL, 120 mg/1.5mL, 400 mg/5mL).
Is Benlysta approved in Europe?
The same active substance is approved in the EU as Benlysta.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA