Banner: About BENLYSTA

What is BENLYSTA?

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What Kind of Medicine is BENLYSTA?

BENLYSTA (belimumab) is a biologic therapy, not a steroid. It is taken in addition to your other lupus medications and is available in three options:

  • an autoinjector you self-inject, for adults
  • a prefilled syringe you self-inject, for adults
  • an intravenous (IV) infusion a healthcare provider administers, for adults and children ages 5 and above

Talk to your doctor to see if BENLYSTA is right for you.

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What’s Different About BENLYSTA?

Unlike other medicines used to treat lupus, BENLYSTA was specifically designed for lupus. In fact, it is the first and only approved treatment designed for lupus. 

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

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The Benefits of BENLYSTA

Adult Patients
In studies used in the approval of BENLYSTA,* when added to other medicines commonly used to treat lupus, compared to other lupus medicines alone, BENLYSTA has demonstrated:

Superior reduction in disease activity
Mainly due to improvements in the immune system, muscles, mouth, joints and skin

Superior reduction in the chance of severe flares 
Reduction in the chance of severe flares occurred in two of the three studies†

Reduction in 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 study

* BLISS-52, BLISS-76, and BLISS-SC.

† A superior reduction in the chance of severe flares did not occur in the BLISS-76 trial.

‡ A numerical reduction in daily steroid dose was observed, but this difference was not big enough for researchers to be sure that BENLYSTA was better than the placebo when added to patients’ current lupus medicine(s).

Your results may vary.

Pediatric Patients (5 years and above)
When added to other medicines commonly used to treat lupus, compared to those medicines alone, BENLYSTA IV has been observed to§:

Reduce lupus disease activity

Reduce the chance of severe flares

§ Because lupus doesn’t occur in children very often, the pediatric study had a much smaller number of patients than the adult studies of BENLYSTA. The study in children was still able to support that BENLYSTA worked, with results similar to those from the adult studies. Due to the small size of the study, however, there was no way to confirm the effect or the consistency of the results.

Please note that these are findings based upon a study in pediatric patients.
Your child’s individual results may vary.

HOW TO TAKE BENLYSTA

 

Studied in Multiple Clinical Trials

BENLYSTA has been studied for FDA approval in the largest successfully-completed series of adult lupus clinical trials ever conducted.

 

Study

Characteristics

BLISS-SC

Evaluated the efficacy, safety and tolerability of BENLYSTA subcutaneous (SC) + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 52 weeks.

BLISS-52

Evaluated the efficacy, safety and tolerability of BENLYSTA intravenous (IV) infusion + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 52 weeks.

BLISS-76

Evaluated the efficacy, safety and tolerability of BENLYSTA intravenous (IV) infusion + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 76 weeks.

These adult trials showed that people treated with a combination of BENLYSTA and other lupus medicines experienced a superior reduction in disease activity at Week 52 compared to people who received the other lupus medicines alone.

Additionally, BENLYSTA was studied in the first pediatric lupus clinical trial ever conducted.

Study

Characteristics

PLUTO

Evaluated the efficacy, safety and pharmacokinetics of BENLYSTA intravenous infusion (IV) + other lupus medicines compared to other lupus medicines alone in children and adolescents (5-17 years) with active SLE.

Are you ready to learn more about BENLYSTA?

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How BENLYSTA Works

Watch this short video to learn more about what lupus is, how it affects the body, and how BENLYSTA works.

TRANSCRIPT

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See the BENLYSTA Experience from their perspective

Learn from other patients as they share their struggles with lupus and discuss their experiences with BENLYSTA.

TRANSCRIPT

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Frequently Asked Questions

  • Yes. BENLYSTA is used to treat children ages 5 and above and adults with active SLE who are receiving other lupus medicines. Intravenous dosing of BENLYSTA is approved for patients 5 years and older, and subcutaneous dosing is only approved for adults. It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.

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  • BENLYSTA is either given by intravenous (IV) infusion (for children ages 5 and above and adults) every 2 weeks for the first three doses and then every 4 weeks thereafter or injected subcutaneously (SC) (for adults only) once a week, either with an autoinjector or a prefilled syringe.

    It is not available in pill form. 

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  • BENLYSTA has been studied in multiple clinical trials involving more than 2,500 adult patients, over 1,100 of whom were treated with BENLYSTA. To date, the pediatric program has included 93 children. BENLYSTA has the largest lupus clinical trial program to date. 

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  • 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.

     

    Risks and side effects

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  • BENLYSTA can cause serious side effects including infections. Symptoms of an infection can include fever, urinating often, chills, coughing up mucus, pain or burning with urination, and warm, red, or painful skin or sores on your body. Tell your healthcare provider right away if you have any of the symptoms listed above while receiving BENLYSTA.

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Looking for a physician?

If you are looking to find a lupus physician to help you or a loved one take the next step with BENLYSTA, we are here to help.

FIND A PHYSICIAN NEAR YOU

Looking for coverage assistance?

When you start BENLYSTA treatment, you also have access to help understanding your health insurance coverage with BENLYSTA Gateway & Co-pay Savings Program. LEARN ABOUT YOUR COVERAGE OPTIONS