Quick answers
- What is Belimumab used for?
- The FDA-approved label (Benlysta, GlaxoSmithKline LLC, August 21, 2026) 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. 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Belimumab have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Belimumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Belimumab been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 21, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Belimumab?
- 1 company lists prescription products of Belimumab in the FDA NDC Directory, including GlaxoSmithKline LLC.
What Belimumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Benlysta, GlaxoSmithKline LLC, effective August 21, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Solution |
|---|---|
| Route | Intravenous · Subcutaneous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Benlysta |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- GlaxoSmithKline LLC3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125370 BENLYSTA | Human Genome Sciences Inc. | March 9, 2011 | 17, latest August 21, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
| BLA761043 BENLYSTA | Glaxosmithkline LLC | July 20, 2017 | 11, latest August 21, 2026 2026: Labeling · 2025: Efficacy · 2024: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 21, 2025 · Class II · Ongoing · D-0540-2025
CGMP Deviations; potential temperature excursions due to transit delays
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK. — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Benlysta, GlaxoSmithKline LLC, effective August 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →