Belimumab

What it is used for

BENLYSTA is indicated for the treatment of patients 5 years of age and older with: Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus.

Use of BENLYSTA is not recommended in this situation. BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients 5 years of age and older with: Active systemic lupus erythematosus (SLE) who are receiving standard therapy; Active lupus nephritis who are receiving standard therapy.

Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system lupus. Use of BENLYSTA is not recommended in this situation.

The most important thing to know

Immunosuppressive agents, including BENLYSTA can cause serious side effects. Some of these side effects may cause death. The following are serious adverse reactions that have occurred in patients receiving BENLYSTA: 1. Infections. Infections could be serious, leading to hospitalization or death. Tell your healthcare provider right away if you have any of the following symptoms of an infection: fever chills pain or burning with urination urinating often coughing up mucus warm, red, or painful skin or sores on your body 2.

Allergic (hypersensitivity) reactions. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death. Your healthcare provider will watch you closely while you are receiving BENLYSTA given in a vein (intravenous infusion) 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 an allergic reaction following use of BENLYSTA: itching swelling of the face, lips, mouth, tongue, or throat trouble breathing anxiousness low blood pressure dizziness or fainting headache nausea skin rash 3.

Mental health problems and suicide. Symptoms of mental health problems can occur. Tell your healthcare provider right away if you have any of the following symptoms: 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 thoughts of hurting yourself or others What is BENLYSTA?

BENLYSTA is a prescription medicine used to treat adults and children 5 years of age and older with: ○active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines, and ○active lupus nephritis (lupus‑related kidney inflammation), 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 central nervous system lupus.

It is not known if BENLYSTA is safe and effective for use in children less than 5 years of age. It is not known if BENLYSTA, given under the skin (subcutaneously), is safe and effective for use in children who weigh less than 33 pounds (15 kilograms). Do not use BENLYSTA if you: are allergic to belimumab or any of the ingredients in BENLYSTA.

See the end of this Medication Guide for a complete list of ingredients in BENLYSTA. Before you receive BENLYSTA, tell your healthcare provider about all of your medical conditions, including 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 allergic to other medicines. are receiving other biologic medicines or monoclonal antibodies.

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. You should talk to your healthcare provider about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, 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 du

Side effects, and when to stop

BENLYSTA can cause serious side effects, including: 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 ○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.

The most common side effects of BENLYSTA include: ○ nausea ○ diarrhea ○ fever ○stuffy or runny nose and sore throat (nasopharyngitis) ○ persistent cough (bronchitis) ○ trouble sleeping (insomnia) ○ leg or arm pain ○ depression ○ headache (migraine) ○ 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. You may report side effects to FDA at 1‑800‑FDA‑1088.

Storing it

Store autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Keep BENLYSTA autoinjectors and prefilled syringes in the original package until time of use to protect from light. Do not shake. Keep away from heat and sunlight. Do not use and do not place back in the refrigerator if left out at room temperature for more than 12 hours.

Safely throw away medicine that is out of date or no longer needed. Keep BENLYSTA and all medicines out of the reach of children.