Why BENLYSTA (belimumab)?

BENLYSTA is the #1 prescribed FDA-approved biologic for both active lupus and active lupus nephritis.


Find out if BENLYSTA could be right for you.

More than ~132,000 people have been prescribed BENLYSTA
Prescribed for more than 15 years by doctors for people with lupus

A single lupus flare can lead to inflammation, which can cause organ damage. Brutal.

Our immune system normally helps protect us from infection and disease. But in people with lupus, the immune system attacks the body. These attacks can cause inflammation, which can lead to the symptoms people with lupus experience during flares. And inflammation from lupus flares can cause long-term damage in many parts of the body.

Just one flare may cause permanent damage to a vital organ.

Up to 50% of people with lupus may go on to develop lupus nephritis, where lupus causes inflammation and can damage the kidneys.

Still having flares, even on medications for lupus or lupus nephritis? Ask your doctor about adding BENLYSTA.

Woman in a red shirt holding a ping pong paddle about to hit a ping pong ball

BENLYSTA brings down disease activity* and prevents lupus flares.†

If you are on treatment and still experiencing flares, talk to your doctor.

 

 

Results may vary.

*In clinical studies, when added to common lupus or lupus nephritis medications, BENLYSTA reduced disease activity when compared to those medications alone.

†BENLYSTA reduced severe lupus flares.

How can adding BENLYSTA to lupus treatment help?

For Lupus

Less Symptoms‡

Lupus symptom improvements were mainly seen in the muscles, joints, skin, mouth, and the immune system.

Less Steroids‡

BENLYSTA 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.§

Less Flares‡

In clinical trials, adding BENLYSTA reduced the risk of severe flares during the first year of use.

Results may vary.

‡ Compared to other lupus medications alone.

§ A reduction of steroid dose was seen but was not statistically significant.

For Lupus Nephritis

Less Kidney Disease Activity‡

BENLYSTA helped maintain kidney function and reduced protein in urine.

Less Steroids‡

BENLYSTA helped reduce the need for rescue medicines, such as high-dose steroids (greater than 10 mg/day).

Maintain Kidney Function‡

BENLYSTA helped maintain kidney function and showed less kidney worsening.

Results may vary.

‡ Compared to other lupus medications alone.

Real Patient Stories

Nadine’s Story

“If you have lupus or lupus nephritis, and you’re not seeing the results you hope for from your current medications, ask your doctor if [adding] BENLYSTA is right for you.”

Watch A Real Patient Story
Smiling BENLYSTA patient Nadine wearing a yellow shirt while standing outside
Nadine, real BENLYSTA patient compensated by GSK

BENLYSTA works differently than standard lupus treatments.

Learn How BENLYSTA Works

Approved Use & Safety Info

Approved Use

Important Safety Information

Approved Use

What is BENLYSTA?

BENLYSTA is a prescription medicine used to treat adults and children 5 years of age and older with active systemic lupus erythematosus (SLE or lupus) or active lupus nephritis (LN) (lupus-related kidney inflammation) who are receiving other lupus medicines. It is not known if BENLYSTA is safe/effective in people with severe active central nervous system lupus.

 

It is not known if BENLYSTA is safe and effective for use in children less than 5 years of age.

 

It is not known if BENLYSTA, given under the skin (subcutaneously), is safe and effective for use in children who weigh less than 33 pounds (15 kilograms).

Important Safety Information

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

 

The most important information about BENLYSTA

 

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 any 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 into 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.

 

Please see Prescribing Information and Medication Guide for BENLYSTA.

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. You may also report negative side effects to GSK at gsk.public.reportum.com or 1-888-825-5249.
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Explore the GSK Help Center website to find customer service support and contact information.

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Pay as little as zero dollars

Eligible commercially insured patients may pay as little as $0 for BENLYSTA, subject to program maximums.*

*Program annual maximums apply. Visit BenlystaCopayProgram.com for information about eligibility and full program terms and conditions.