How BENLYSTA Works
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.
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.
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.
Additional Important Safety Information will be presented later in the program.
Part 1: The Immune System, B-cells and Antibodies
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.
Part 2: Autoreactive B Cells, Inflammation, and Lupus
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.
Part 3: How BENLYSTA® (belimumab) Works
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.
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 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 (also known as 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:
- Stuffy or runny nose and sore throat (nasopharyngitis)
- Cough (bronchitis)
- Trouble sleeping
- Leg or arm pain
- 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.
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, talk to your healthcare provider.
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.