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real lupus patients taking BENLYSTA (belimumab).

Answers from a Doctor

Dr. Elaine Lambert is a rheumatologist in Redwood City, California. Dr. Lambert is a paid spokesperson for GSK. Click on the video below to hear her answer to the question “What is lupus?”.

What is Lupus?

Learn about the basics of lupus and how problems with the immune system can lead to lupus.

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Dr. Lambert is a paid spokesperson for GSK.

Questions and Answers from Dr. Mease

Dr. Philip Mease is a rheumatologist in Seattle, Washington. Dr. Mease is a paid spokesperson for GSK.

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Dr. Mease: Clinical trials are medical research studies that test the safety and effectiveness of a drug. BENLYSTA IV was tested in the largest clinical trial program involving people with systemic lupus erythematosus ever conducted. This clinical trial program involved three different trials and involved 2,133 patients.

In the trials of BENLYSTA, BENLYSTA was added to other treatments. These treatments, which varied among the people who participated in the trials, are accepted by experts and widely used to treat lupus symptoms including steroids, nonsteroidal anti-inflammatory drugs (also called NSAIDS) antimalarials and immunosuppressants.

Dr. Mease: The results of these clinical trials showed that BENLYSTA plus other lupus treatments was superior to other lupus treatments alone in reducing lupus disease activity. The reduction in disease activity seen with BENLYSTA plus other lupus treatments was mainly due to improvements in parts of the body most commonly affected among the participants in the trials. These body areas included the skin, the mouth, the joints and muscles and the immune system.

Dr. Mease: In a person with lupus, some B cells, called autoreactive B cells, react against your own body. These cells contribute to symptoms of lupus.

Dr. Mease: Researchers have discovered a protein known by the abbreviation B-L-Y-S, or BLyS, which stimulates the growth of these autoreactive B cells. BENLYSTA works by binding to the BLyS protein. In other words, BENLYSTA prevents BLyS from stimulating the type of B cells that have been associated with lupus. So adding BENLYSTA to your lupus treatments may help reduce the abnormal immune system activity seen in lupus.

Dr. Mease: It is important to know that BENLYSTA is not a steroid. BENLYSTA contains belimumab, which belongs to a group of drugs called monoclonal antibodies. These are large, complex proteins produced in laboratories. Monoclonal antibodies copy the disease fighting response of your natural antibodies.

Dr. Mease: Drugs, such as BENLYSTA, which are made of complex proteins, cannot be taken by mouth. That's because these protein-based medications would be broken down in the stomach before they ever reach the bloodstream. Once BENLYSTA is broken down, it cannot work properly. BENLYSTA IV is given directly into the bloodstream through an intravenous infusion.

Dr. Mease: In some cases, you may get your infusion at your doctor's office. In other cases, you may get it at a hospital or an infusion center. In general, when you arrive for your treatment, a healthcare professional, such as a nurse, will take you to a room where others may also be receiving infusions.

Dr. Mease: Your infusion with BENLYSTA IV will take about an hour to complete, with additional preparation time before and observation time after the infusion.

Dr. Mease: Before starting the infusion, the nurse may ask you how you are feeling and will likely check your blood pressure, pulse and temperature. After answering some questions about your medical history, you may receive medications prior to the infusion. For example, you may receive an antihistamine to help reduce your chance of having an allergic reaction. The nurse or other healthcare professional will then insert an IV line into your arm or hand so that you can receive your infusion of BENLYSTA IV. While they are inserting the IV line, you may feel some pain or discomfort. Also, if you've been given an antihistamine, you may feel tired.

Dr. Mease: Some people like to bring something along to occupy themselves during their infusion, such as a book or crossword puzzle. Of course, you can always close your eyes and get some rest while you are receiving the infusion of BENLYSTA IV.

Dr. Mease: After the infusion, you may feel some discomfort where you had the IV line inserted. That should go away within a few hours. Depending on how you feel, you may be able to return to your usual activities once the infusion process is over. However, if you were given an antihistamine, you may feel drowsy and may want to go home and rest for a while. If you are drowsy, it is important that you have someone drive you home.

If you don't feel well or have any soreness or tenderness that doesn't go away, contact your healthcare professional.

NOTE: BENLYSTA is an add-on treatment. It is intended to be used together with other lupus medicines.

Real answers from a real person

Call the BENLYSTA Gateway toll-free Monday-Friday 8AM – 8PM ET at 1-877-4-BENLYSTA (1-877-423-6597)

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Visit our FAQ section for answers

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: fever, chills, pain or burning with urination, urinating often, coughing up mucus, shortness of breath, or diarrhea/vomiting.
  • Heart problems: chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
  • Allergic (hypersensitivity) reactions: itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, or skin rash. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.
  • Mental health problems and suicide: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping, 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 IV 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. Females who are able to become pregnant should talk to their healthcare provider about whether or not they will 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 during your treatment with BENLYSTA or if you think you may be pregnant. If you become pregnant while receiving BENLYSTA, 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 this 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 talk about whether or not you should receive BENLYSTA and breastfeed.

Possible side effects of BENLYSTA

  • Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. PML can result in death or severe disability. Tell your healthcare provider right away if you notice any new or worsening medical problems: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.
  • Cancer. Medicines that affect the immune system including BENLYSTA, may increase your risk of certain cancers.

The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.

Other Important Information

In clinical studies, there have been mixed results regarding how well BENLYSTA works in black/African American patients. Therefore, you should consult with your healthcare provider to determine if BENLYSTA is right for you.


Please see Prescribing Information and Medication Guide for BENLYSTA.

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.