Why BENLYSTA (belimumab)?

BENLYSTA is the first and only FDA-approved treatment for both lupus and lupus nephritis. Discover BENLYSTA and find out if it could be right for you. 

Morgan (left), real BENLYSTA patient compensated by GSK

Is BENLYSTA right for me?

If you identify with these statements, talk to a doctor about adding BENLYSTA to your current treatment plan.

Icon: Patient

I’ve been diagnosed with lupus and/or lupus nephritis

When you're living with lupus, it’s important to reduce lupus disease activity and the risk of severe lupus flares. BENLYSTA can help.

Icon: Lupus Treatments

I’m currently taking medicines to treat my condition

BENLYSTA works with your other lupus medicines as an add-on therapy to reduce lupus disease activity.* It works by targeting an underlying cause of lupus.

Icon: Patient

I’m still experiencing lupus symptoms and severe flares

If active disease is left untreated, lupus can damage many different organ systems including muscles, joints, skin, and kidneys. 

Results may vary.
 *In studies used in the approval of BENLYSTA, when added to other common lupus medications, compared to those medications alone.

Benefits of BENLYSTA

BENLYSTA was studied in the largest completed series of lupus and lupus nephritis clinical trials.

Select one to see the study results: 

In three clinical studies of adult patients with active lupus, BENLYSTA*:

Icon: Reduced Disease Activity
Significantly reduced disease activity

mainly related to improvements in the immune system, muscles, joints, mouth, and skin.†

Icon: Patient
Significantly reduced risk of severe flares

in two of the three studies.†

Icon: Steroid pill bottle
Reduced steroid dose by 25% or more

(to a daily dose of 7.5 mg or less) during Weeks 40-52, in patients receiving 7.5 mg or higher daily doses of steroid at the start of the studies.†‡

Results may vary.
 *Studies used in the FDA approval of BENLYSTA 
†Compared to other lupus medicines alone
‡A reduction of steroid dose was seen but was not statistically significant.

In a 2-year clinical study of adult patients with active lupus nephritis, BENLYSTA:

Icon: Reduced Disease Activity
Significantly reduced kidney disease activity

with maintained kidney function, reduced protein in the urine, and reduced need for rescue medicines.*†

Icon: Kidneys
Significantly reduced risk of kidney worsening

during the study by almost 50%.*

Results may vary.
*Compared to other lupus medicines alone
†Such as steroids greater than 10 mg/day

Icon: BENLYSTA Patient Elijah

“I’m fighting lupus, and I take BENLYSTA to help me keep up the fight.”

Elijah, real BENLYSTA patient compensated by GSK

See Elijah’s Story

How BENLYSTA works

BENLYSTA is a biologic therapy, not a steroid. Watch this short video to see how BENLYSTA targets an underlying cause of lupus.

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Show Transcript

NARRATOR: 
What is BENLYSTA?
BENLYSTA is a prescription medicine for adults with active systemic lupus erythematosus (SLE or lupus) or active lupus nephritis on other lupus medicines. BENLYSTA is not for people with severe active central nervous system lupus.

Important Safety Information
Do not use BENLYSTA if you are allergic to belimumab or any ingredients in BENLYSTA.

Please click the Important Safety Information tab to the left to watch or hear the Important Safety Information about BENLYSTA.

ON-SCREEN TEXT:
What is BENLYSTA?
BENLYSTA is a prescription medicine for adults with active systemic lupus erythematosus (SLE or lupus) or active lupus nephritis on other lupus medicines. BENLYSTA is not for people with severe active central nervous system lupus.

Important Safety Information
Do not use BENLYSTA if you are allergic to belimumab or any ingredients in BENLYSTA.

Please click the Important Safety Information tab to the left to watch or hear the Important Safety Information about BENLYSTA.

[BENLYSTA logo (belimumab)]

ON-SCREEN TEXT: 
[BENLYSTA logo; BENLYSTA (belimumab) Intravenous Use 120 mg/vial Subcutaneous Use 200 mg/mL]

Part 1: The Immune System, B Cells, and Antibodies

NARRATOR: 
The human immune system is made up of organs and lymphatic vessels and nodes. 

ON-SCREEN TEXT:
Thymus
Spleen
Lymphatic Vessels and Nodes

NARRATOR:
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. 

ON-SCREEN TEXT:
Lymphatic Vessels and Nodes

NARRATOR:
B cells, a type of white blood cell, are an important component of the immune system. 

ON-SCREEN TEXT:
B-Cells

NARRATOR:
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. 

ON-SCREEN TEXT: 
Antibodies
Germs

NARRATOR:
Working together, the many parts of the immune system play a vital role in maintaining health. 

ON-SCREEN TEXT:
[BENLYSTA logo; BENLYSTA (belimumab) Intravenous Use 120 mg/vial Subcutaneous Use 200 mg/mL]

Part 2: Autoreactive B Cells, Inflammation, and Lupus

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. 

ON-SCREEN TEXT:
Systemic Lupus Erythematosus = SLE

NARRATOR:
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. 

ON-SCREEN TEXT:
Autoreactive B-Cells

NARRATOR:
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. 

ON-SCREEN TEXT:
Autoantibody

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

ON-SCREEN TEXT:
[BENLYSTA logo; BENLYSTA (belimumab) Intravenous Use 120 mg/vial Subcutaneous Use 200 mg/mL]

Part 3: How BENLYSTA (belimumab) Works)

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 autoreactive B cells – is called BLyS. BLyS is short for B-lymphocyte stimulator. BENLYSTA works by binding to BLyS. 

ON-SCREEN TEXT:
BLyS
BENLYSTA

NARRATOR:
When BENLYSTA is attached to BLyS, BLyS can no longer bind to and stimulate the autoreactive 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.

And now, Important Safety Information about BENLYSTA. 

ON-SCREEN TEXT:
[BENLYSTA logo; BENLYSTA (belimumab) Intravenous Use 120 mg/vial Subcutaneous Use 200 mg/mL]

Important Safety Information

NARRATOR:
 What is BENLYSTA?
BENLYSTA is a prescription medicine for adults with active systemic lupus erythematosus (SLE or lupus) or active lupus nephritis on other lupus medicines. BENLYSTA is not for people with severe active central nervous system lupus. Do not use BENLYSTA if you are allergic to belimumab or any ingredients in BENLYSTA.

ON-SCREEN TEXT:
What is BENLYSTA?

BENLYSTA is a prescription medicine for adults with active systemic lupus erythematosus (SLE or lupus) or active lupus nephritis on other lupus medicines. BENLYSTA is not for people with severe active central nervous system lupus.

Important Safety Information
Do not use BENLYSTA if you are allergic to belimumab or any ingredients in BENLYSTA.

The most important information about BENLYSTA
NARRATOR and ON-SCREEN TEXT:
Immunosuppressive agents, including BENLYSTA, can cause serious side effects. Some of these may cause death.

  • Infections: fever, chills, pain or burning with urination, urinating often, coughing up mucus, or warm, red, or painful skin or sores on your body. Infections could be serious, leading to hospitalization or death. 
  • 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 the day of, or in days after, receiving BENLYSTA and may cause death.
  • Mental health problems and suicide: 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, discuss with your healthcare provider if you:

  • think you have an infection or have infections that keep coming back. Do not use 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 or may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.
  • are taking medicines, including prescription, over-the-counter, vitamins, and herbal supplements.
  • are allergic to other medicines.
  • are receiving other biologic medicines.
  • have or have had any type of cancer.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is unknown if BENLYSTA will harm your unborn baby. Talk to your healthcare provider about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control for at least 4 months after the final dose of BENLYSTA.
  • 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 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/benlysta-belimumab/.
  • are breastfeeding or plan to breastfeed. It is unknown if BENLYSTA passes on to your breast milk.

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, persistent 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. 

ON-SCREEN TEXT:
For more information and access to Prescribing Information and Medication Guide, visit www.BENLYSTA.com or call 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. 

BENLYSTA Cares
Have questions or need assistance? Call 1-877-4-BENLYSTA (1-877-423-6597)
Whether you need treatment support or financial assistance, BENLYSTA Cares may be able to help.

[GSK logo]
Trademarks are owned by or licensed to the GSK group of companies.
©2023 GSK or licensor.
BELVID230015 November 2023
Produced in USA.
[BENLYSTA logo; BENLYSTA (belimumab) Intravenous Use 120 mg/vial Subcutaneous Use 200 mg/mL]

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In many people with lupus, certain white blood cells called autoreactive B cells stay in the body longer than they should. One of the important proteins for the growth of the B cells is called B-lymphocyte stimulator, or BLyS. BENLYSTA binds to BLyS and prevents it from stimulating B cells.

Ask your doctor if BENLYSTA could be right for you.

How BENLYSTA compares

BENLYSTA is the first and only FDA-approved treatment for both lupus and lupus nephritis. 

It’s available for adults in 2 administration options—subcutaneous (SC) injection or intravenous (IV) infusion. For children ages 5 and above with active lupus or lupus nephritis, BENLYSTA is available as an IV infusion.

Table comparing benlysta, saphnelo, and lupkynis, including what they treat, how it's administered, and dosing information
  BENLYSTA Logo Saphnelo Logo Lupkynis Logo
Treats  
Lupus  
Lupus
Nephritis		  
Available in  
Self-Injection

1x per week*

   
Infusion

1x every 2 weeks for first 3 doses, then 1x every 4 weeks

1x every 4 weeks

 
Capsule    

14x per week

Information above does not suggest comparison of benefits or safety of treatments shown. See more in each product’s prescribing information.

*Your healthcare provider will tell you how often you should use BENLYSTA. If you have lupus nephritis, one dose may be 2 injections.
Saphnelo is a registered trademark of AstraZeneca.
Lupkynis is a registered trademark of Aurinia Pharmaceuticals.

Frequently asked questions

Expand All     Collapse All

  • When might I start to see results with BENLYSTA?

    While BENLYSTA clinical trials were not designed to measure when BENLYSTA started to work, it was observed that most patients who responded to BENLYSTA did so within the first 7 months of treatment.

    Results may vary.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • Is BENLYSTA a steroid?

    BENLYSTA is not a steroid—it is a biologic therapy that targets an underlying cause of lupus.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • How is BENLYSTA administered?

    For children ages 5 and above and adults, BENLYSTA can be administered by your healthcare provider through an intravenous (IV) infusion. For adults, BENLYSTA can also be self-injected once a week through a subcutaneous (SC) injection, either with an autoinjector or a prefilled syringe.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • What are the most common side effects of BENLYSTA?

    The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, persistent cough, trouble sleeping, leg or arm pain, depression, headache, pain, redness, itching, or swelling at the site of injection (when given subcutaneously).

    These are not all the possible side effects of BENLYSTA. Talk to your healthcare provider for medical advice about side effects.

    Safety and Side Effects

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

Real BENLYSTA patient experiences

If you and your doctor are considering adding BENLYSTA for lupus or lupus nephritis, hear other people talk about their own experiences.

See Stories

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