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BENLYSTA:

  • is not a steroid.
  • is not a pill, but is either given by intravenous (IV) infusion or self-injected subcutaneously (SC) meaning under the skin.
  • is a protein that can help reduce abnormal immune system activity that contributes to lupus disease activity.
  • has been studied in three different clinical trials involving over 2,500 patients.
  • when added to other lupus medicines, was proven to reduce disease activity.

What is BENLYSTA?
BENLYSTA is a prescription medicine used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

BENLYSTA contains belimumab which is in a group of medicines called monoclonal antibodies.

Lupus is a disease of the immune system (the body system that fights infection). When given together with other medicines for lupus, BENLYSTA decreases lupus disease activity more than other lupus medicines alone.

  • It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.
  • It is not known if BENLYSTA is safe and effective in children.
About BENLYSTA

You and your healthcare professional are the best people to determine what treatment is right for you. As the first treatment approved for lupus in more than 50 years, BENLYSTA provides a treatment option to be taken with your other lupus medicines. In three clinical trials, BENLYSTA plus other lupus medicines significantly reduced lupus disease activity more than other lupus medicines alone.

This reduction in disease activity was mainly due to improvements in the parts of the body most commonly affected in patients living with lupus: the skin, mouth, joints, muscles, and the immune system.

For most patients who responded to BENLYSTA, they did so within the first 7 months of treatment and continued to respond over the course of the clinical trials (one year).

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BENLYSTA has been studied in three different clinical trials involving more than 2,500 patients, over 1,100 of whom were treated with BENLYSTA. The largest SLE clinical trial program to date.

About BENLYSTA

Before taking BENLYSTA
You should know that 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, shortness of breath, or warm, red or painful skin on your body.

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.

Allergic (hypersensitivity) reactions: Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death.

Tell your healthcare provider right away if you have any of the following symptoms of an allergic 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.

Mental health problems and suicide: Symptoms can include 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.

Risks and side effects

The most common side effects of BENLYSTA include:

  • nausea
  • diarrhea
  • fever
  • stuffy or runny nose and sore throat
  • persistent cough
  • trouble sleeping
  • 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. Call your doctor for medical advice about side effects.

Risks and side effects

In 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 B cells is called B-lymphocyte stimulator, or BLyS. BENLYSTA binds to BLyS and prevents it from stimulating B cells.

Get more information on how BENLYSTA works

BENLYSTA is not for everyone.

Ask your doctor if BENLYSTA is right for you. Here are a few things your doctor may consider before prescribing BENLYSTA:

  • If you have already been diagnosed with systemic lupus erythematosus (SLE).
  • If you are currently taking medicines to help manage your lupus.
  • If your lupus has continued to be active.

Remember, only you and your doctor can decide whether BENLYSTA is right for you.

Other information to consider

  • It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.
  • It is not known if BENLYSTA is safe and effective in children.

BENLYSTA and pregnancy

  • Before you receive BENLYSTA, tell your healthcare provider if you 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 you 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 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 the registry is to monitor the health of you and your baby.
  • Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should decide if you will receive BENLYSTA and breastfeed.

BENLYSTA and Black/African Americans

  • 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.

This is not the full list of the things your healthcare professional will need to consider before prescribing BENLYSTA. For more information, refer to the Medication Guide for BENLYSTA and talk to your doctor.

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Talk to your doctor.

You should not make any changes in your medication regimen without first consulting your doctor.

BENLYSTA is a prescription medicine used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. When given together with other medicines for lupus, BENLYSTA reduces lupus disease activity more than other lupus medicines alone.

Talk to your doctor

BENLYSTA is not chemotherapy.

BENLYSTA is also not a steroid – it's a biologic therapy, delivered either through an intravenous (IV) infusion or subcutaneous (SC) self-injection.

or subcutaneous (SC) self-injection.

How BENLYSTA works
  • BENLYSTA can be administered by your healthcare provider through an IV infusion. It is given every 2 weeks for the first 3 doses and then at 4-week intervals thereafter. Find out more here.
  • BENLYSTA can also be self-injected once a week through a subcutaneous (SC) injection, either with an autoinjector or a prefilled syringe.
    Read more here.
How to take BENLYSTA

Financial Support

Costs vary

Each insurance policy is different. Costs depend on your individual plan. Your insurance generally pays part of the costs and you pay the remaining part.

To understand your cost for BENLYSTA, contact your insurance company or call BENLYSTA Cares at 1-877-4-BENLYSTA. BENLYSTA Cares works with BENLYSTA Gateway, our patient support service that can research your estimated cost for BENLYSTA under your insurance policy. You can find out more here.

There are some common terms that are helpful to understand. Words like:

  • Premium: the amount paid routinely (each month or pay period, for example) to the insurer
  • Deductible: a fixed amount you pay “up front” before the insurance company pays
  • Co-payment (co-pay) and co-insurance are cost sharing arrangements.
    • Co-payment: the specified flat amount you pay for a specific service.
    • Co-insurance: the percentage you pay for a specific service.
  • Out-of-pocket maximum is the maximum dollar amount that you will be required to pay annually.
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Check with your insurance

While most insurance companies offer coverage for BENLYSTA, actual coverage can vary.

To understand how your insurance covers BENLYSTA, you will need to contact your insurance company or call BENLYSTA Cares at 1-877-4-BENLYSTA.

BENLYSTA Cares works with BENLYSTA Gateway, our patient support service that can provide information as to whether your insurance plan covers BENLYSTA for you and may be able to provide options for cost-savings and financial support

Coverage support options

Co-pay savings

Even if you have insurance, but are not able to afford your medication, the BENLYSTA Co-pay Program may be able to help. Subject to eligibility. Restrictions apply.

Call 1-877-4-BENLYSTA from 8 am - 8 pm Eastern Time, Monday through Friday.

Co-pay savings

The BENLYSTA Co-pay Program is for people:

  • Who have private, non–government–funded commercial insurance (not a state government or federal government insurance plan like Medicare or Medicaid), or
  • Whose insurance does not provide coverage for BENLYSTA, or
  • Are uninsured, AND
  • Meet other eligibility requirements.
Co-pay savings