Benlysta (Belimumab) for 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. BENLYSTA is also known by its generic name, belimumab.

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.

BENLYSTA is the first lupus treatment approved by the FDA in over 50 years. BENLYSTA targets one of the abnormalities in the immune system that contributes to the development of SLE. BENLYSTA is believed to work by reducing the number of white blood cells called B-lymphocytes that contribute to autoimmune attacks in lupus. BENLYSTA is also a biologic medication. It is not a steroid.

In clinical trials, BENLYSTA plus other lupus medicines was superior to other lupus medicines alone in reducing lupus disease activity. This reduction was mainly seen in improvements in the skin, mouth, joints, muscles and immune system, the systems most often affected by lupus disease activity.

How Do I Take It?
BENLYSTA is available in two forms: a self-injection and an intravenous infusion. BENLYSTA for subcutaneous use (200 mg/mL) is a self-injectable that you can take once each week at a time that is convenient for you in the comfort of your own home. It comes in an autoinjector or a prefilled syringe. BENLYSTA for intravenous use is an infusion that is administered once a month in your doctor’s office or an infusion center.

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.

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.

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 IV 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. Tell your healthcare provider if you become pregnant during your treatment with BENLYSTA. 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. 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 provider should discuss whether or not you should receive BENLYSTA and breastfeed.  
 
Possible side effects of BENLYSTA
• Mortality. There were more deaths reported with BENLYSTA than with
placebo during the controlled period of clinical trials.
• Serious Infections. Serious and sometimes fatal infections have been
reported in patients receiving immunosuppressive agents, including
BENLYSTA. Use with caution in patients with severe or chronic
infections. Consider interrupting therapy with BENLYSTA if patients
develop a new infection during treatment with BENLYSTA.
• 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: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.
• Cancer. BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.
• Hypersensitivity Reactions, including Anaphylaxis. Serious and fatal
reactions have been reported. BENLYSTA for intravenous use should be
administered by healthcare providers prepared to manage anaphylaxis.
Monitor patients during and for an appropriate period of time after
intravenous administration of BENLYSTA.
• Depression. Depression and suicidality have been reported in trials with
BENLYSTA. Patients should be instructed to contact their healthcare
provider if they experience new or worsening depression, suicidal
thoughts, or other mood changes.

The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection. These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.

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. Consult with your healthcare provider to determine if BENLYSTA is right for you.

824903R0