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About BENLYSTA

Ask your doctor about BENLYSTA, the first FDA-approved treatment for lupus in over 50 years.

BENLYSTA is the first prescription treatment in over 50 years approved for adults with active, systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. BENLYSTA is not a steroid—it's a biologic therapy, delivered through an intravenous (IV) infusion. It works by reducing certain cells in your immune system that can make lupus active.

Studies have found that adding BENLYSTA to commonly used lupus medications can reduce lupus disease activity. In fact, in clinical trials, BENLYSTA plus other lupus treatments was superior to other lupus treatments alone in reducing lupus disease activity. It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.

Quick Facts

BENLYSTA is...

  • not a steroid
  • added to your other lupus medications
  • prescription-only
  • given by intravenous (IV) infusion
  • the first lupus treatment approved by the FDA in over 50 years

Patient Experience

Susan, Morgan and Michelle discuss how they felt about the possibility of receiving treatments with BENLYSTA.

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GSK sponsors ambassadors for BENLYSTA and pays them for their time and expense in sharing their experiences.
Individual results may vary.

History of BENLYSTA

BENLYSTA is the first FDA-approved medication in over 50 years to treat adults with active lupus. It is the first in a drug class known as BLyS-specific inhibitors.

In 1996, researchers identified a naturally occurring protein in the human body called BLyS (pronounced "bliss"), short for B-lymphocyte stimulator. Clinical studies showed there was a connection between higher levels of BLyS and lupus disease activity in some people. BENLYSTA binds to BLyS and prevents it from stimulating B cells.

FDA approved BENLYSTA on March 9, 2011, providing an additional option to treat lupus.

$0 Co-Pay

for eligible patients*

Learn about BENLYSTA infusions

Learn all about how, where, and when BENLYSTA infusions happen.

* Up to a total of $9,000 annually. Does not cover the cost of doctor's office visits or administration of BENLYSTA. Subject to eligibility requirements.

What Is BENLYSTA?

BENLYSTA is a prescription medication used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus, and it has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.

Important Safety Information

The most important information to know about BENLYSTA:

BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects.

Important Safety Information

The most important information to know about BENLYSTA:

BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects.

Tell your healthcare professional right away if you have any of the symptoms listed below while receiving BENLYSTA

Do not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.

Before receiving BENLYSTA also discuss with your healthcare professional if you:

Women of childbearing age should use adequate birth control measures while taking BENLYSTA and for at least four months after their final treatment with BENLYSTA.

Remember to tell your healthcare professional about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Possible side effects of BENLYSTA

The most common side effects of BENLYSTA include:

Tell your healthcare professional if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of BENLYSTA. For more information, ask your healthcare professional.

Other Important Information

In 2 of 3 studies, fewer blacks/African Americans who received BENLYSTA responded to treatment compared to blacks/African Americans who did not receive BENLYSTA. Therefore, caution should be used when considering treatment with BENLYSTA in blacks/African Americans. It is important to discuss with your healthcare professional whether BENLYSTA is right for you. A clinical trial is ongoing to study BENLYSTA specifically in blacks/African Americans with lupus.


For more information, call the BENLYSTA® Gateway at 1-877-4-BENLYSTA (1-877-423-6597)
Monday through Friday, 8 AM to 8 PM Eastern Time.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.