h your healthcare provider about your medical condition or your treatment.
What is the most important information I should 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 provider right away if you have any of the symptoms listed below while receiving BENLYSTA.
1.
Infections. Symptoms of an infection can include:
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fever
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chills
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pain or burning with urination
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urinating often
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bloody diarrhea
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coughing up mucus
2.
Heart Problems. Symptoms of heart problems can include:
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chest discomfort or pain
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shortness of breath
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cold sweats
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nausea
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dizziness
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discomfort in other areas of the upper body
3.
Mental health problems and suicide. Symptoms of mental health problems can include:
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thoughts of suicide or dying
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attempt to commit suicide
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trouble sleeping (insomnia)
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new or worse anxiety
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new or worse depression
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acting on dangerous impulses
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other unusual changes in your behavior or mood
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thoughts of hurting yourself or others
What is BENLYSTA?
BENLYSTA is a prescription medicine used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.
BENLYSTA contains belimumab which is in a group of medicines called monoclonal antibodies. Lupus is a disease of the immune system (the body system that fights infection). People with active lupus often have high levels of a certain protein in their blood. BENLYSTA binds to and limits the activity of the protein. When given together with other medicines for lupus, BENLYSTA decreases lupus disease activity more than other lupus medicines alone.
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It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.
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It is not known if BENLYSTA is safe and effective in children.
Who should not receive BENLYSTA?
Do not receive BENLYSTA if you:
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are allergic to belimumab or any of the ingredients in BENLYSTA. See the end of this Medication Guide for a complete list of ingredients in BENLYSTA.
What should I tell my healthcare provider before receiving BENLYSTA?
Before you receive BENLYSTA, tell your healthcare provider if you:
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think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your healthcare provider tells you to. See “What is the most important information I should know about BENLYSTA?”
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have or have had mental health problems such as depression or thoughts of suicide
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have recently received a vaccination or if you think you may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.
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are allergic to other medicines
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are receiving other biologic medicines, monoclonal antibodies or IV infusions of cyclophosphamide (Cytoxan®)
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have or have had any type of cancer
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have any other medical conditions
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are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. Tell your healthcare provider if yo |
