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Learn more about living with lupus and treatment with BENLYSTA

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When it comes to treating lupus, it helps to have a clear understanding of what you're dealing with. Refer back to this page for definitions of terms used throughout this website.


Proteins inside the body that are part of the immune system. Antibodies attach themselves to foreign invaders (such as bacteria, viruses, etc.) to keep them from causing disease.

Any substance the body recognizes as a foreign invader.

While originally developed to treat malaria, these drugs are used to treat lupus.

Antibodies that work against your body. They are produced by autoreactive B cells.

Any substance produced by the body that the immune system in someone with lupus recognizes as being foreign.

Cells that react against the body. These are the cells responsible for creating autoantibodies.

Also called B lymphocytes, these are cells in the body that fight foreign invaders by creating antibodies.

The active ingredient in BENLYSTA, this protein helps to reduce abnormal immune system activity which helps to reduce the signs and symptoms of lupus.

A treatment derived from living tissues or cells.

A specific protein necessary for the survival of B cells. Too much BLyS, however, allows the autoreactive B cells to build up in the body.

A class of medications that prevent BLyS proteins from stimulating the growth of autoreactive B cells.

The abbreviation for British Isles Lupus Assessment Group index. This index measures lupus disease activity in 8 organs/body systems.

A carefully planned investigation of the effects of a particular medicine or medicines on humans. The usual goal of a clinical trial is to evaluate a drug's effectiveness as well as its safety profile.

These medicines, often simply called steroids, are used to reduce inflammation.

A drug used in the treatment of cancer that is sometimes also used to treat lupus.

The number and severity of the signs and symptoms of a disease.

The Food and Drug Administration, a division of the US Department of Health and Human Services. Among many other responsibilities, the FDA handles the approval, regulation, and supervision of prescription drugs.

A complex system of tissues, organs, and processes that work to protect the body from harmful foreign invaders.

Drugs that are used to suppress immune system activity.

A solution of medication injected into a vein.

A chronic disorder in which the immune system attacks the body; this can lead to inflammation. Also see systemic lupus erythematosus.

Proteins produced in laboratories that copy the disease-fighting response of your natural antibodies to a specific antigen.

Drugs that are used to reduce pain and inflammation.

Short for "Physician's Global Assessment." This is a general assessment of a patient's overall well-being, which the physician rates on a scale from "0" (no disease activity) to "3" (severe disease activity).

A physician who specializes in disorders that cause pain, soreness, or stiffness in muscles or joints. These disorders include lupus and arthritis.

A scale that includes 24 signs and symptoms that may be experienced with lupus. SELENA stands for "Safety of Estrogens in Lupus Erythematosus National Assessment" and SLEDAI, for "Systemic Lupus Erythematosus Disease Activity Index."

The established, accepted course of treatment for a disease.

A disease that results from abnormal activity in your immune system.

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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, or call 1-800-FDA-1088.