Benlysta Patient Tips

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on July 3, 2025.

1. How it works

• Benlysta (generic name: belimumab) is a prescription biologic medicine that works in the immune system (the system that fights infection) to target and destroy certain cells. It works by targeting an underlying cause of lupus. Belimumab is in a group of medicines called monoclonal antibodies It is not a steroid medicine.
• Benlysta is a B-lymphocyte stimulator (BLyS)-specific inhibitor and works by inhibiting (blocking) 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 used with other lupus treatments to treat active systemic lupus erythematosus (SLE) and active lupus nephritis (lupus-related kidney inflammation) in adults and children 5 years of age and older who are receiving other standard lupus medicines. When given with other lupus medicines, it works better than other medicines given alone
• 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.

2. Upsides

• 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 and children 5 years and older for systemic lupus erythematosus (SLE) and active lupus nephritis (LN). The subcutaneous form comes as a single-dose prefilled autoinjector or as a single-dose prefilled syringe. The prefilled syringe has not been studied in children less than 18 years of age, but the autoinjector pen can be used in children 5 years and older.
• For adults and children for active SLE or lupus nephritis, starter IV doses are weight-based and given at 2-week intervals for the first 3 doses, then as IV maintenance doses given every 4 weeks.
• The subcutaneous formulation comes as either as a single-dose prefilled syringe or a single-dose autoinjector for use at home. For adults for both SLE and LN, subcutaneous dosing is not weight-based and is given once per week. For children, subcutaneous dosing (using the autoinjector only) is based on weight and is given once weekly or once every 2 weeks. Give the injections on the same day each week or the same day every 2 weeks, as directed.
• The prefilled syringe is only used in adults. It is injected in your stomach area (abdomen) or thigh area. You, or a caregiver, can be taught to give the subcutaneous injections at home. For patients less than 10 years of age, subcutaneous Benlysta must be administered by a healthcare professional or trained caregiver.
• You can switch from IV dosing to subcutaneous dosing if approved by your doctor. After training, follow the directions for administration provided in the Instructions for Use in the product information or call your healthcare provider if you have questions.

3. Downsides

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 (stuffy, runny nose, sore throat), bronchitis (persistent cough), insomnia (trouble sleeping), pain in extremity (like your arm or leg), depression, migraine headache, injection site reactions (with subcutaneous injection) like pain, redness itching or swelling, 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). Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system like Benlysta. PML can cause severe disability or death. 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.
• It is not known if Benlysta is safe and effective for use in children under 5 years of age or if subctaneous use (injected under the skin) is safe and effective in children who weigh less than 33 pounds (15 kilograms).
• Benlysta is not recommended in patients with severe active central nervous system (CNS) lupus as its effectiveness is not known.
• 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. Intravenous formulations should be administered by healthcare providers prepared to manage anaphylaxis (a severe, possibly life-threatening allergic reaction). You may receive medicines first to help prevent reactions when given by the IV route.
• For active lupus nephritis, one subcutaneous dose may require 2 injections at the start of treatment for 4 weeks (the starting doses are higher). Thereafter, only one injection is needed.
• 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 day / time or based on your new day of injection. Call your doctor if you are not sure when or where to inject your medicine.
• There is no generic or biosimilar as of July 2025.

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

4. Bottom Line

Benlysta is an injectable non-steroid prescription medicine used with other medicines to treat systemic lupus erythematosus (SLE) and active lupus nephritis (lupus-related kidney inflammation) in adults and children 5 years of age and older. It works by inhibiting the survival of B cells (a type of white blood cell) in the immune system. It is classified as a B-lymphocyte stimulator (BLyS)-specific inhibitor.

5. Tips

• Tell your doctor if you think you have an infection. You should not start Benlysta if you have an infection, unless your doctor tells you otherwise.
• 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.
• 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 may give you medicines before you receive Benlysta to help reduce your chance of having a 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, thoughts of suicide or other mood changes. 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. If you are not sure what the ingredients are, ask your doctor or pharmacist or look on the patient Medication Guide provided with your medicine.
• Speak with your doctor about any vaccines you may need before you start treatment.
• 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. Before you start treatment, tell your doctor if you are receiving other biologic medicines or monoclonal antibodies.
• Tell your healthcare provider right away if you become pregnant or if you think you may be pregnant while taking this medicine. You and your doctor should discuss if you should take this medicine while breastfeeding.
• If you become pregnant while receiving this medicine, talk to your healthcare provider about enrolling in the Benlysta Pregnancy Registry. You can enroll in this registry by calling 1-877-311-8972.
• Tell your doctor, pharmacist and other healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal products or dietary supplements.
• Always read the Instructions for Use and Medication Guide that comes with your medicine. Store autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze or shake the medicine. Keep in original package until you use it to help protect from light. Keep away from heart and sunlight.
• Do not use and do not place back in the refrigerator if your Benlysta is left out at room temperature for more than 12 hours.
• Do not use this medicine for a condition for which it was not prescribed by your doctor. Do not share this medicine with anyone else, even if they have your same symptoms, as it may harm them.
• Do not stop any treatments or make any changes to your medication regimen without first consulting your doctor.

6. Response and effectiveness

• Benlysta (belimumab), from the manufacturer GSK, was first approved in March 2011 as treatment for adults with active systemic lupus erythematosus (SLE). Since that time, it has approved for other uses.
• 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 (LN).
• 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 and children with SLE or lupus nephritis. However, only the autoinjector subcutaneous formulation is approved for children 5 years and older with active SLE and LN weighing at least 15 kg (33 pounds). The prefilled syringe subcutaneous form has not been studied in children less than 18 years of age.
• Benlysta is not recommended in patients with severe active central nervous system (CNS) 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.

7. Interactions

• Formal drug interaction studies have not been performed with Benlysta (belimumab), 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), and / or 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 signs or symptoms suggestive of PML and may stop treatment if needed.

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Frequently asked questions

• What is the difference between Benlysta and Saphnelo?
• What's the difference between Lupkynis and Benlysta?
• Does Benlysta cause weight gain?
• Where do you inject Benlysta?
• How long does it take for Benlysta injections to work?
• Can Benlysta cause an allergic reaction?
• How does Benlysta help lupus?
• How long does a Benlysta infusion take?
• Does Benlysta cause hair loss?

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use benlysta only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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