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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.
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.
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 BENLYSTA treatment in blacks/African Americans. It is important to discuss with your healthcare professional whether BENLYSTA is right for you. A clinical trial is planned to study BENLYSTA specifically in blacks/African Americans with lupus.
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.
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.