• Benlysta (generic name: belimumab) is a biologic therapy that works in the immune system to target and destroy certain cells. It works by targeting an underlying cause of lupus. It is not a steroid medicine.
• Benlysta is classified as a B-lymphocyte stimulator (BLyS)-specific inhibitor and inhibits (blocks) the survival of B cells (a type of white blood cell). Benlysta binds to BLyS and prevents it from stimulating the growth of B cells, which may worsen your symptoms.
• Benlysta (pronounced ben-LIST-ah) is a prescription medicine used with other lupus treatments to treat active systemic lupus erythematosus (SLE) and active lupus nephritis (lupus-related kidney inflammation) in adults and children.
• SLE is the most common form of lupus, a chronic, incurable autoimmune disease that attacks body systems and organs. Lupus nephritis is a serious inflammation of the kidneys which can lead to dialysis or a kidney transplant.

• Benlysta comes as both an intravenous (IV) formulation (given as an injection into a vein) and a subcutaneous formulation (given as an injection just under the skin).
• Both the intravenous (IV) and subcutaneous forms are used in adults, but only the IV form is used in children.
• Starter IV doses are given at 2-week intervals for the first 3 doses, then IV maintenance doses are given every 4 weeks. Subcutaneous dosing is given once per week on the same day each week. Subcutaneous dosing is not based on your weight.
• The subcutaneous formulation comes as either a single-dose autoinjector or as a single-dose prefilled syringe (sometimes called an autoinjector) for use at home. It is injected in your stomach (abdomen) or thigh area. You, or a caregiver, can be taught to give the subcutaneous doses at home.
• You can switch from IV dosing to subcutaneous dosing if approved by your doctor.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nausea, diarrhea, fever, common cold symptoms, bronchitis (persistent cough), insomnia (trouble sleeping), pain in extremity (like your arm or leg), depression, migraine headache, injection site reaction with subcutaneous injection), and pharyngitis (sore throat).
• Benlysta can lower the action of your immune system which may make it more likely that you can have serious side effects, a higher risk of infections, serious or deadly allergic reactions, or certain cancers. Some of these side effects may cause hospitalization or death. It can also cause serious mental health problems and suicidal thoughts or actions.
• This medicine can cause a very serious and life-threatening brain infection called progressive multifocal leukoencephalopathy (PML). If you experience any of these side effects, tell your doctor right away: memory loss, trouble thinking, dizziness, loss of balance, trouble walking, trouble talking, or vision problems.
• Only the intravenous (IV) formulation of Benlysta (not the subcutaneous) is approved for use in children. Subcutaneous dosing has not been evaluated and is not approved for patients younger than 18 years. It is not known if Benlysta is safe and effective for use in children under 5 years of age when given in a vein (intravenously).
• It takes about one hour to give the IV infusion, but you may need to be at the clinic for a longer period of time. Premedication may be needed to help prevent injection reactions when given by the IV route.
• If you have lupus nephritis, one dose may require 2 injections at the start of treatment. It is not known if Benlysta is safe and effective for use in children under 18 years of age when given under the skin (subcutaneously).
• Benlysta is not recommended in patients with severe active central nervous system lupus.
• You should not receive live vaccines while receiving Benlysta. Examples of lives vaccines include the nasal flu vaccine, chickenpox and measles, mumps, rubella (MMR combined vaccine), but there are others. Speak with your doctor about vaccines you may need before you start treatment.
• It is not known if Benlysta will harm an unborn baby. Speak with your healthcare provider about whether you should prevent pregnancy while taking this medicine. If so, 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 miss a subcutaneous dose, inject it as soon as you remember. Continue with your scheduled weekly injections at your regular time or based on your new day of injection. Call your doctor if you are not sure when to inject your medicine.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• If you experience side effects like fever, chills, pain or burning with urination, frequent urination, coughing up mucus, or warm, red, or painful skin or sores on your body, call your doctor right away. You may be at risk of a serious or deadly infection. You should not start Benlysta if you have an infection, unless your doctor tells you otherwise.
• If you have side effects like itching, skin rash, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness, fainting, headache, or nausea, call your doctor or emergency medical services (911) right away. You may be at risk of a serious or deadly allergic reaction.
• 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 an allergic reaction. However, reactions can sometimes be delayed and may occur after you leave the clinic. Learn how to recognize an allergic reaction.
• Tell your doctor before you start treatment if you have mental health problems such as depression or thoughts of suicide. If you have side effects during treatment like thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety or depression, acting on dangerous impulses, thoughts of hurting yourself or others, or other unusual changes in your behavior or mood, call your doctor right away or call 911.
• Do not use this medicine if you are allergic to belimumab or any inactive ingredients in Benlysta.
• Be sure to tell your doctor if you are allergic to this medicine, are pregnant or planning a pregnancy, if you have or have had cancer, are breastfeeding or plan to breastfeed.
• Tell your healthcare provider right away if you become pregnant or if you think you may be pregnant while taking this medicine.
• Tell your doctor, pharmacist and other healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal or dietary supplements.
• Always read the Instructions for Use and Medication Guide that comes with your medicine.
• Do not stop any treatments or make any changes to your medication regimen without first consulting your doctor.

• Benlysta (belimumab), from the manufacturer GSK, was first approved in March 2011 as treatment for adults with active systemic lupus erythematosus (SLE).
• In July 2017, the FDA approved the subcutaneous (injected under the skin) form of Benlysta for adults with active, autoantibody‑positive SLE who are receiving standard therapy.
• In May 2019, the FDA cleared Benlysta to be used in children 5 to 17 years of age with SLE.
• In December 2020, Benlysta was approved to treat adults with active lupus nephritis.
• In July 2022, Benlysta was approved for children 5 to 17 years of age who have lupus nephritis.

Both the intravenous (IV) and subcutaneous formulations of Benlysta are approved for use in adults with SLE and lupus nephritis. The IV formulation of Benlysta (but not the subcutaneous) is approved for use in children at least 5 years old with SLE and lupus nephritis.

Benlysta is not recommended in patients with severe active central nervous system lupus.

Active systemic lupus erythematosus (Active SLE)

• In 3 clinical studies (up to 75 weeks duration) with over 2,100 adult patients with SLE showed the safety and effectiveness of Benlysta compared to placebo (inactive) agent (plus standard therapy in both groups).
• Standard therapy included (alone or in combination): corticosteroids, antimalarials, NSAIDs, and immunosuppressives. Most patients (>70%) were receiving 2 or more different classes of SLE medicines.
• Benlysta at a 10 mg/kg dose (but not the 1 mg/kg dose) significantly reduced disease activity showing improvements in areas related to the mouth, skin, muscles and joints.

• In 2 studies, Benlysta reduced the risk of a severe disease flare. Some patients were able to lower their steroid dose by 25% or more.

• In May 2019, the FDA cleared Benlysta in the 52-week PLUTO study of 93 children (5 to 17 years) with SLE.

• Results showed a higher proportion of patients receiving Benlysta IV plus standard therapy achieved the primary endpoint compared to those who received placebo plus standard therapy.

Active lupus nephritis

• In a 2-year long study of adults with active lupus nephritis, Benlysta significantly reduced kidney disease activity with reduced protein appearing in the urine.
• It also reduced the need for rescue medications, such as higher-dose steroids, and maintained kidney function when compared to other lupus medicines.
• In addition, it significantly reduced the risk of kidney worsening during the study by almost one-half.

Formal drug interaction studies have not been performed with Benlysta, but no drug interactions have been identified in clinical trials when administered with certain medicines, such as:

• corticosteroids
• antimalarials
• immunomodulatory and immunosuppressive agents (including azathioprine, cyclophosphamide, methotrexate, and mycophenolate)
• angiotensin pathway antihypertensives (like ACE inhibitors or ARBs)
• HMG-CoA reductase inhibitors (statins)
• non-steroidal anti-inflammatory drugs (NSAIDs).

The drug interaction effect of belimumab on other drugs has not been evaluated.

You should not receive live vaccines while receiving Benlysta. Speak with your doctor about any vaccines you may need before you start treatment.

Drugs that suppress your immune system may increase the risk of serious infections including progressive multifocal leukoencephalopathy (PML). There are certain medicines you should never use if you have or have had PML. Your doctor will monitor you for any new sign or symptom suggestive of PML and may stop treatment if needed.