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

In people with lupus, some B cells stay in the body longer than they should. These are called autoreactive B cells. These autoreactive B cells are cells that react against your own body in lupus. 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.

What is lupus?

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

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Dr. Mease 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 what causes the disease, lupus 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.

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, and a complete medical history.

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.

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 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 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.
  • 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 those below, 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
  • 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 treatment with BENLYSTA in blacks/African Americans. It is important to discuss with your healthcare professional 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.