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Learn more about living with lupus and treatment with BENLYSTA

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real lupus patients taking BENLYSTA.

Why BENLYSTA?

BENLYSTA was tested in the largest successful SLE clinical trial program to date. Clinical trials are medical research studies that test the safety and effectiveness of a drug. BENLYSTA was used with a number of other lupus treatments that are accepted by experts and widely used to treat lupus symptoms. These therapies, which varied from person to person, included:

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.

Clinical trial results

When the trials were completed, they showed that more people treated with BENLYSTA plus other lupus treatments experienced a reduction in disease activity than those who received the other treatments alone. This reduction in disease activity was mainly due to improvements in the parts of the body most commonly affected among people participating in the trials: the skin, the mouth, the joints and muscles, and the immune system.

How BENLYSTA works

Find out the role BENLYSTA plays in treating lupus

Considering BENLYSTA?

Talk to your doctor to see if BENLYSTA is right for you.

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.

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

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 provider 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, coughing up mucus, or skin or sores that are warm, red or painful.
  • 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 or depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.

Before receiving BENLYSTA also discuss with your healthcare provider 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 provider 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 taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • are allergic to other medicines.
  • are receiving other biologic medicines, monoclonal antibodies or intravenous infusions of cyclophosphamide (Cytoxan®).
  • have or have had any type of cancer.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. If you are able to become pregnant, you should talk to your healthcare provider about whether or not to use birth control (contraception) and receive BENLYSTA. If BENLYSTA is recommended, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA.
  • Tell your healthcare provider right away if you become pregnant or you think you may be pregnant while receiving treatment with BENLYSTA. If you become pregnant, talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of the registry is to monitor the health of you and your baby.
  • are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should discuss whether or not you should receive BENLYSTA and breastfeed.

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 allergic or infusion reactions can happen on the day of or days after receiving BENLYSTA and may cause death. Your healthcare provider will watch you closely while you are receiving BENLYSTA and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed; tell your healthcare provider 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 provider or get emergency medical help right away if you have any of these symptoms.
  • Progressive multifocal leukoencephalopathy (PML): PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including BENLYSTA. PML can result in death or severe disability. If you notice any new or worsening medical problems such as the following, tell your healthcare provider right away: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.

The most common side effects of BENLYSTA include:

  • Nausea
  • Diarrhea
  • Fever
  • Stuffy or runny nose and sore throat (nasopharyngitis)
  • Cough (bronchitis)
  • Trouble sleeping
  • Leg or arm pain
  • Depression
  • Headache (migraine)

Tell your healthcare provider 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.

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, it is important to discuss with your healthcare provider 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.