Benlysta (belimumab)
An approved treatment for Lupus Nephritis.
The same compound appears under different names depending on the context. Here is how to identify Belimumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Belimumab
- Brand name
- Benlysta
- Drug class
- BLyS-specific inhibitor (monoclonal antibody)
- Manufacturer
- GlaxoSmithKline
- How it's taken
- By vein, 10 mg/kg every 2 weeks for 3 doses and then every 4 weeks.
An infusion or under-the-skin injection for lupus that is also approved for active lupus nephritis in patients 5 and older who are receiving standard therapy.
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Where Belimumab fits
Added to standard therapy for active lupus nephritis, and also used for lupus itself.
How Belimumab works
Belimumab binds BLyS, a survival signal for B cells, so it cannot reach them. With less BLyS, fewer B cells survive, including the ones that make the autoantibodies driving lupus. It does not bind B cells directly.
Mechanism: Antibody that blocks BLyS, a protein B cells need to survive
Side effects and safety
Benlysta has no boxed warning. Its label warns about serious infections, allergic reactions including anaphylaxis, depression and suicidal thoughts, a possible higher risk of cancer and, from August 2026, Stevens-Johnson syndrome and toxic epidermal necrolysis, rare severe skin reactions. In the lupus nephritis trial, infections occurred in 82% on Benlysta against 76% on placebo, and serious infections in 14% against 17%; other side effects matched those seen in lupus, such as nausea, diarrhea and fever.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Belimumab
By vein, 10 mg/kg every 2 weeks for 3 doses and then every 4 weeks. Adults can instead inject 400 mg under the skin weekly for 4 doses and then 200 mg weekly; children's under-the-skin doses are based on weight.
Availability and cost
Only available as the brand-name product.
Help paying for Benlysta
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible patients with commercial insurance may pay as little as $0 through the BENLYSTA Copay Program, subject to annual maximums.
For: private insurance · source - Free medicine program
The GSK Patient Assistance Program can provide Benlysta at no cost to eligible patients who are uninsured or on Medicare.
For: no insurance, Medicare · source - Insurance and case manager help
Checks your insurance coverage, explains cost options and assigns a Patient Navigator.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Access and eligibility
Approved for active lupus nephritis in patients 5 years and older who are also receiving standard therapy.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
In BLISS-LN (NCT01639339), 448 adults with lupus nephritis added Benlysta or placebo to standard therapy. At 2 years, 43% on Benlysta had a kidney response against 32% on placebo, and 30% against 20% had a complete kidney response.
Development history
First approved by the FDA on March 9, 2011 for lupus. Its label now also covers active lupus nephritis in patients 5 and older who are receiving standard therapy.
Explore Lupus Nephritis trials
Other Lupus Nephritis treatments
Common questions about Belimumab
▸What is Belimumab (Benlysta)?
An infusion or under-the-skin injection for lupus that is also approved for active lupus nephritis in patients 5 and older who are receiving standard therapy.
▸How does Belimumab work?
Belimumab binds BLyS, a survival signal for B cells, so it cannot reach them. With less BLyS, fewer B cells survive, including the ones that make the autoantibodies driving lupus. It does not bind B cells directly.
▸What are the side effects of Belimumab?
Benlysta has no boxed warning. Its label warns about serious infections, allergic reactions including anaphylaxis, depression and suicidal thoughts, a possible higher risk of cancer and, from August 2026, Stevens-Johnson syndrome and toxic epidermal necrolysis, rare severe skin reactions. In the lupus nephritis trial, infections occurred in 82% on Benlysta against 76% on placebo, and serious infections in 14% against 17%; other side effects matched those seen in lupus, such as nausea, diarrhea and fever.
▸How is Belimumab taken?
By vein, 10 mg/kg every 2 weeks for 3 doses and then every 4 weeks. Adults can instead inject 400 mg under the skin weekly for 4 doses and then 200 mg weekly; children's under-the-skin doses are based on weight.
▸Is Belimumab FDA approved?
Yes, Belimumab (Benlysta) is FDA approved (2011) for the treatment of Lupus Nephritis.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-08. BENLYSTA (belimumab): prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2fa3c528-1777-4628-8a55-a69dae2381a3
- ClinicalTrials.gov. BLISS-LN: belimumab in active lupus nephritis. https://clinicaltrials.gov/study/NCT01639339