Ask your doctor about BENLYSTA, the first FDA-approved treatment for lupus in over 50 years.
BENLYSTA is the first prescription treatment in over 50 years approved for adults with active, systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines. BENLYSTA is not a steroid—it’s a biologic therapy, delivered through an intravenous (IV) infusion. It works by reducing certain cells in your immune system that can make lupus active.
Studies have found that adding BENLYSTA to commonly used lupus medications can reduce lupus disease activity. In fact, in clinical trials, BENLYSTA plus other lupus treatments was superior to other lupus treatments alone in reducing lupus disease activity. 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 combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
not a steroid
added to your other lupus medications
given by intravenous (IV) infusion
the first lupus treatment approved by the FDA in over 50 years
Susan, Morgan and Michelle discuss how they felt about the possibility of receiving treatments with BENLYSTA.
History of BENLYSTA
BENLYSTA is the first FDA-approved medication in over 50 years to treat adults with active lupus. It is the first in a drug class known as BLyS-specific inhibitors.
In 1996, researchers identified a naturally occurring protein in the human body called BLyS (pronounced "bliss"), short for B-lymphocyte stimulator. Clinical studies showed there was a connection between higher levels of BLyS and lupus disease activity in some people. BENLYSTA binds to BLyS and prevents it from stimulating B cells.
FDA approved BENLYSTA on March 9, 2011, providing an additional option to treat lupus.
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.
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 professional 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, bloody diarrhea, or coughing up mucus.
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, new or worse depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.
Do not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.
Before receiving BENLYSTA also discuss with your healthcare professional 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 professional 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 allergic to other medicines.
are receiving other biologic medicines, monoclonal antibodies or IV infusions of cyclophosphamide (Cytoxan).
have or have had any type of cancer.
are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. Tell your healthcare professional if you become pregnant during your treatment with BENLYSTA.
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 this 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 professional should decide if you will receive BENLYSTA or breastfeed. You should not do both.
Women of childbearing age should use adequate birth control measures while taking BENLYSTA and for at least four months after their final treatment with BENLYSTA.
Remember to tell your healthcare professional about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
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 professional 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 professional 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 those below, tell your healthcare provider right away:
dizziness or loss of balance
difficulty talking or walking, or
loss of vision.
The most common side effects of BENLYSTA include:
Stuffy or runny nose
Leg or arm pain
Urinary tract infection
Decreased white blood cell count (leukopenia)
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. For more information, ask your healthcare professional.
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, caution should be used when considering treatment with BENLYSTA in blacks/African Americans. It is important to discuss with your healthcare professional 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.