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About Lupus

Lupus is a disease that is caused by something going wrong with the immune system — the part of the body that fights off invaders, such as viruses, bacteria, and other germs. Typically, B cells in our immune system produce proteins called antibodies that protect the body from these invaders.

Normal Immune System

normal-immune-system normal-immune-system

Abnormal Immune System

In a person with lupus, some B cells, called autoreactive B cells, react against your own body. The autoreactive B cells produce a type of protein called an autoantibody. Unlike normal antibodies, which react against foreign invaders, the autoantibodies attack your own body. In lupus, this can lead to inflamed body tissue.

abnormal-immune-system abnormal-immune-system

Who does lupus affect?

Lupus fact: Lupus affects more women than men. About 90% of people living with lupus are women. While nobody knows for certain why lupus occurs, scientists believe many factors combine to cause it. These may include hormones and environmental factors. Lupus also appears to have a genetic component and can run in families.

What is Lupus?

Learn about the basics of lupus and how it affects the immune system.

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Dr. Lambert is a paid spokesperson for GSK.

Who does lupus affect?

Lupus fact: Lupus affects more women than men. About 90% of people living with lupus are women. While nobody knows for certain why lupus occurs, scientists believe many factors combine to cause it. These may include hormones and environmental factors. Lupus also appears to have a genetic component and can run in families.

What triggers lupus?

Lupus fact: A number of factors may potentially trigger the disease, including infections, toxins, and environmental factors. Ultraviolet light, such as sunlight, has been shown to trigger lupus disease activity in up to 70% of people living with lupus.

Diagnosing lupus

Lupus fact: Lupus affects everyone differently. Symptoms are wide-ranging and can change over time. This unpredictability can make lupus difficult to diagnose. An accurate diagnosis can take months or even years to determine. Yet, certain symptoms are fairly common. For example, the skin is usually involved. Specific symptoms include rashes, sun sensitivity, nose and mouth sores, and hair loss.

The start of lupus may be acute, appearing like an infection, or it may be a succession of vague, or seemingly disconnected, symptoms over time. Because the symptoms come and go and vary for each person, evaluation by a healthcare professional well acquainted with lupus—most often a rheumatologist—is critical for an accurate diagnosis. This evaluation may include a physical examination, laboratory tests, including blood tests, and a complete medical history. Specific tests a healthcare professional might use to evaluate disease activity in lupus include the Physicians Global Assessment (PGA) and the SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score.

For additional information about lupus, please visit these sites or contact these organizations.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Lupus information from the US government.

http://www.niams.nih.gov/Health_Info/Lupus/default.asp

Lupus Foundation of America

The largest national non-profit voluntary health organization dedicated to the lupus community, research and support.

http://www.lupus.org/

Lupus Research Institute

Information on new research and scientific efforts to prevent, treat, and cure lupus.

http://www.lupusresearchinstitute.org/

The web sites listed are external to GSK. GSK does not have control over the content or the information provided on these web sites and therefore does not warrant the accuracy or completeness of any content or information on these sites.

See Dr. Lambert's answer

What is lupus?

What happens in lupus?

How BENLYSTA works

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.