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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.

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

• Infections: Symptoms can include fever, chills, pain or burning with urination, urinating often, bloody diarrhea, or coughing up mucus.
• Heart Problems: Symptoms can include chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
• Mental health problems and suicide: Symptoms can include thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.

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:

• 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 professional tells you to.
• have or have had mental health problems such as depression or thoughts of suicide.
• 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.
• are allergic to other medicines
• are receiving other biologic medicines, monoclonal antibodies or IV infusions of cyclophosphamide (Cytoxan).
• have or have had any type of cancer.
• are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. Tell your healthcare professional if you become pregnant during your treatment with BENLYSTA.
• are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare professional should decide if you will receive BENLYSTA or breastfeed. You should not do both.

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:

• Cancer. BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.
• Allergic (hypersensitivity) and infusion reactions. Serious reactions can happen on the day of or the day after receiving BENLYSTA and may cause death. Tell your healthcare professional right away if you have any of the following symptoms of a reaction: itching; swelling of the face, lips, mouth, tongue, or throat; trouble breathing; anxiousness; low blood pressure; dizziness or fainting; headache; nausea; or skin rash, redness, or swelling. Tell your healthcare professional or get emergency medical help right away if you have any of these symptoms.

The most common side effects of BENLYSTA include:

• Nausea
• Diarrhea
• Fever
• Stuffy or runny nose
• Cough (bronchitis)
• Trouble sleeping
• Leg or arm pain
• Depression
• Headache (migraine)
• Sore throat
• Urinary tract infection
• Decreased white blood cell count (leukopenia)
• Vomiting
• Stomach pain

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 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.