GSK is currently experiencing an inventory shortage for BENLYSTA. This is a temporary situation and is not related to product quality. The availability of BENLYSTA at your infusion center may be variable over the next month or two until supply is fully re-established. We understand this may impact your ability to get your infusions as currently scheduled. Please work with your Healthcare Provider to determine availability of BENLYSTA and the treatment options that are best for you. GSK is committed to resolving this as quickly as possible to minimize disruption but we know that some patients will be impacted. Thank you for your understanding. If you have additional questions you can contact the GSK Response Center at 1-888-825-5249, Monday - Friday, 8:30 am - 5:30 pm ET.
Lupus is a disease that occurs when something is going wrong with the immune system — the part of the body that fights off invaders, such as viruses, bacteria, and other germs. Typically, B cells in our immune system produce proteins called antibodies that protect the body from these invaders.
Normal Immune System
In a person with lupus, some B cells become autoreactive, that is they react against that individual's own tissues in the body. The autoreactive B cells produce a type of protein called an autoantibody. Unlike normal antibodies, which react against foreign invaders like germs, the autoantibodies attack that person's own body. In lupus, this can lead to inflamed body tissue.
What is lupus?
Learn about the basics of lupus and how it affects the immune system.
Lupus fact: Lupus affects more women than men. About 90% of people living with lupus are women. While nobody knows for certain what causes the disease, lupus appears to have a genetic component and can run in families.
What triggers lupus?
Lupus fact: A number of factors may potentially trigger the disease, including infections, toxins, and environmental factors. Ultraviolet light, such as sunlight, has been shown to trigger lupus disease activity in up to 70% of people living with lupus.
Lupus fact: Lupus affects everyone differently. Symptoms are wide-ranging and can change over time. This unpredictability can make lupus difficult to diagnose. An accurate diagnosis can take months or even years to determine.
The start of lupus may be acute, appearing like an infection, or it may be a succession of vague, or seemingly disconnected, symptoms over time. Because the symptoms come and go and vary for each person, evaluation by a healthcare professional well-acquainted with lupus—most often a rheumatologist—is critical for an accurate diagnosis. This evaluation may include a physical examination, laboratory tests, and a complete medical history.
For additional information about lupus, please visit these sites or contact these organizations.
The web sites listed are external to GSK. GSK does not have control over the content or the information provided on these web sites and therefore does not warrant the accuracy or completeness of any content or information on these sites.
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.