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Learn more about living with lupus and treatment with BENLYSTA

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How BENLYSTA Works

NORMAL B CELL
NORMAL B CELL
This type of white blood cell produces antibodies
ANTIBODY
ANTIBODY
Antibodies attach themselves to germs and try to control or destroy them
GERM
GERM
Viruses, bacteria, and other invaders
BENLYSTA
BENLYSTA
Human monoclonal antibody that binds the B lymphocyte stimulator protein (BLyS)
HEALTHY BODY TISSUE
HEALTHY BODY TISSUE Tissue unaffected by lupus disease activity
AUTOREACTIVE B CELL
AUTOREACTIVE B CELL
These are the "bad" version of B cells that make autoantibodies that may be harmful
AUTOANTIBODY
AUTOANTIBODY
While antibodies protect the body, autoantibodies work against the body
BLyS
BLyS
B Lymphocyte Stimulator (BLyS) is a protein that helps some cells survive including the bad autoreactive B cells
INFLAMED BODY
TISSUE
INFLAMED BODY TISSUE
Part of the body's protection process, also a sign of lupus disease activity
View [Transcript]

NARRATOR:

BENLYSTA (belimumab) 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. Additional Important Safety Information will be presented later in the program.

NARRATOR:

The human immune system is made up of organs and lymphatic vessels and nodes. It also consists of cells and a wide range of chemical messengers and other proteins that are produced by these cells of the immune system.

This is the system that helps protect us from infections caused by bacteria, viruses and other germs. B cells, a type of white blood cell, are an important component of the immune system.

These cells recognize and fight germs by producing a special type of protein called an antibody. Antibodies recognize and latch onto germs. This attachment is a key step in how the immune system protects from infection and fights infection. Working together, the many parts of the immune system play a vital role in maintaining health.

NARRATOR:

When the immune system is not working properly, however, it can cause illness rather than help maintain health. Systemic lupus erythematosus, or “SLE” is one of many diseases caused by abnormal immune system activity. In many people with lupus, certain B cells remain in the body longer than they should.

These cells, called “autoreactive B cells” play a role in causing lupus.

Like other B cells, autoreactive B cells can produce antibodies. But the antibodies released by autoreactive B cells do not fight germs. Instead, these antibodies—which are called “autoantibodies,” attach to normal tissues inside the body.

When this happens, the autoantibodies end up attacking your own body and tissues can become inflamed.

NARRATOR:

All of the cells of the immune system are influenced by chemical messengers.

For example, one of the chemical messengers that binds to and helps the growth of B cells—including auto reactive B cells—is called “BLyS.” BLyS is short for “B Lymphocyte Stimulator.”

BENLYSTA works by binding to BLyS.

When BENLYSTA is attached to BLyS, BLyS can no longer bind to and stimulate the auto reactive B cells. Adding BENLYSTA to your other lupus treatments may help reduce the abnormal immune system activity that contributes to disease activity in lupus.

If you are considering BENLYSTA, ask your doctor about whether this medication may be right for you.

Please review the following Important Safety Information about BENLYSTA.

NARRATOR:

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 professional 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 professional 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.

NARRATOR:

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, visit BENLYSTA dot com. Call BENLYSTA® Gateway at one—eight- seven- seven—four - BENLYSTA, Monday through Friday, eight AM to eight PM Eastern Time.

See the full prescribing information and Medication Guide for BENLYSTA available on this website.

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.

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

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:

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

The most common side effects of BENLYSTA include:

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.

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.