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Frequently asked questions about BENLYSTA

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BENLYSTA

BENLYSTA:

  • is not a steroid.
  • is not a pill, but given by IV infusion.
  • is a protein that may help reduce abnormal immune system activity that contributes to lupus disease activity.
  • when added to other lupus treatments, was proven to help reduce disease.

Read the full story of 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 clinical trials, BENLYSTA plus other lupus medicines helped reduce 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 among people participating in the trials: the skin, mouth, joints, muscles, and the immune system.

BENLYSTA was tested in the largest SLE clinical trial program to date. There were 3 clinical trials with BENLYSTA. These 3 trials had a total of 2,133 patients with active SLE.

  • Trial 1 was conducted in North America. Trial 2 was conducted primarily in North America and Europe. Trial 3 was conducted in South America, Eastern Europe, Asia, and Australia.

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, or skin or sores that are warm, red or painful.

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.

Mental health problems and suicide: Symptoms can include 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, and thoughts of hurting yourself or others.

The most common side effects of BENLYSTA include:

  • nausea
  • diarrhea
  • fever
  • stuffy or runny nose and sore throat (nasopharyngitis)
  • cough (bronchitis)
  • trouble sleeping
  • leg or arm pain
  • depression
  • headache (migraine)

Tell your healthcare professional if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of BENLYSTA.

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.

Adding BENLYSTA to your other lupus treatments may help reduce the abnormal immune system activity that contributes to disease activity in lupus.

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 medications 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.
  • BENLYSTA has not been studied in people receiving biologic medicines or intravenous cyclophosphamide to treat lupus. Use of BENLYSTA with these medicines is not recommended.

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 to 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 or think you may be pregnant while receiving treatment with BENLYSTA. If you become pregnant, 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 African Americans

  • In 2 of 3 studies, fewer blacks/African Americans who received BENLYSTA responded to treatment compared to blacks/African Americans who did not receive BENLYSTA. Therefore, it is important to discuss with your healthcare provider whether BENLYSTA is right for you. A clinical trial is ongoing to study BENLYSTA specifically in blacks/African Americans with lupus.

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.

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 decreases lupus disease activity more than other lupus medicines alone.

BENLYSTA is not chemotherapy.

BENLYSTA is also not a steroid—it's a biologic therapy, delivered through an intravenous (IV) infusion.

Financial Assistance

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 BENLYSTA Gateway. BENLYSTA Gateway is a patient support service that can research your estimated cost for BENLYSTA under your insurance policy. To start the process, call 1-877-4-BENLYSTA from 8 AM—8 PM Eastern Time, Monday through Friday.

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

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 BENLYSTA Gateway for assistance. BENLYSTA Gateway is a patient support service that can provide information as to whether your insurance plan covers BENLYSTA for you.

To start the process, call BENLYSTA Gateway at 1-877-4-BENLYSTA from 8 AM—8 PM Eastern Time, Monday through Friday.

Financial assistance service

If you have insurance, but are not able to afford your medication, the BENLYSTA Co-pay Program may be able to help.

Call 1-877-4-BENLYSTA from 8 AM—8 PM Eastern Time, Monday through Friday.

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.

Learn about financial support programs

Visit BENLYSTA® Gateway to get answers about BENLYSTA answered by a live person on our toll-free support line.

Increase your lupus vocabulary

Consult our glossary of definitions of words and phrases

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: Symptoms can include fever, chills, pain or burning with urination, urinating often, coughing up mucus, or skin or sores that are warm, red or painful.
  • 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.
  • Mental health problems and suicide: Symptoms can include 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 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 intravenous 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. If you are able to become pregnant, you should talk to your healthcare provider about whether or not to 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 or you think you may be pregnant while receiving treatment with BENLYSTA. If you become pregnant, 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.
  • are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should discuss whether or not you should receive BENLYSTA and breastfeed.

Possible side effects of BENLYSTA

  • Cancer: BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.
  • Allergic (hypersensitivity) and infusion reactions: Serious allergic or infusion reactions can happen on the day of or days after receiving BENLYSTA and may cause death. Your healthcare provider will watch you closely while you are receiving BENLYSTA and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed; tell your healthcare provider right away if you have any of the following symptoms of a 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, redness, or swelling. Tell your healthcare provider or get emergency medical help right away if you have any of these symptoms.
  • Progressive multifocal leukoencephalopathy (PML): PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including BENLYSTA. PML can result in death or severe disability. If you notice any new or worsening medical problems such as the following, tell your healthcare provider right away: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.

The most common side effects of BENLYSTA include:

  • Nausea
  • Diarrhea
  • Fever
  • Stuffy or runny nose and sore throat (nasopharyngitis)
  • Cough (bronchitis)
  • Trouble sleeping
  • Leg or arm pain
  • Depression
  • Headache (migraine)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of BENLYSTA.

Other Important Information

In 2 of 3 studies, fewer blacks/African Americans who received BENLYSTA responded to treatment compared to blacks/African Americans who did not receive BENLYSTA. Therefore, it is important to discuss with your healthcare provider whether BENLYSTA is right for you. A clinical trial is ongoing to study BENLYSTA specifically in blacks/African Americans with lupus.


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.