Pronunciation: ben-LIST-ah
Generic name: belimumab
Dosage form: single-dose vial for intravenous infusion (120 mg/vial, 400 mg/vial), prefilled syringe for subcutaneous use (200 mg/mL), prefilled autoinjector for subcutaneous use (200 mg/mL)
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 25, 2025.

What is Benlysta?

Benlysta is used for active systemic lupus erythematosus (SLE) or lupus nephritis in adults and children 5 years and older. It is given by subcutaneous (under the skin) injection or via an intravenous (into a vein) infusion every 1 to 4 weeks.

Benlysta works by targeting and blocking a protein called B-lymphocyte stimulator (BLyS) that helps B-cells survive and produce antibodies. In lupus, B-cells are overactive and produce harmful autoantibodies that attack healthy tissue. By blocking BLyS, Benlysta reduces the survival rate of B cells, decreases production of autoantibodies, and helps control an overactive immune response, improving symptoms such as fatigue, and reducing flares associated with SLE and lupus nephritis. Benlysta belongs to the drug class called B-lymphocyte stimulator (BLyS)-specific inhibitors.

Benlysta (belimumab) gained FDA approval on March 9, 2011. There is no generic or biosimilar.

FDA approvals and uses

Benlysta is approved to treat adults and children aged 5 years and older with

• active systemic lupus erythematosus (SLE) who are receiving standard therapy 
• active lupus nephritis who are receiving standard therapy.

Benlysta is not approved for severe active central nervous system lupus because its effectiveness has not been evaluated.

Side effects

The most common side effects of Benlysta are:

• nausea
• diarrhea
• fever 
• sore throat, runny or stuffy nose (nasopharyngitis)
• persistent cough (bronchitis)
• bronchitis
• pain, itching, redness, or swelling where an injection was given under the skin
• pain in your arms or legs
• headache (migraine)
• depression
• sleep problems (insomnia).

Hair loss and weight gain are not common side effects of Benlysta.

Serious side effects and warnings

Benlysta may cause the following serious side effects:

• 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
  • urinating often
  • chills
  • coughing up mucus
  • pain or burning with urination
  • warm, red, or painful skin or sores on your body.
• 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 your Benlysta infusion and afterwards 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
  • low blood pressure
  • swelling of the face, lips, mouth, tongue, or throat
  • dizziness or fainting
  • headache
  • trouble breathing
  • nausea
  • anxiousness
  • skin rash.
• 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
  • new or worse depression
  • attempt to commit suicide
  • acting on dangerous impulses
  • trouble sleeping (insomnia)
  • other unusual changes in your behavior or mood
  • new or worse anxiety
  • thoughts of hurting yourself or others.
• 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.

Live vaccines should not be given concurrently with this medicine.

It is not known if Benlysta is safe for children younger than 5 years.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before receiving

Do not receive a Benlysta injection or infusion if you are allergic to belimumab, Benlysta, or any inactive ingredients in the subcutaneous injection or intravenous infusion.

Before receiving, tell your healthcare provider about all 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, such as measles, mumps, or varicella
• are receiving other cyclophosphamide, biologic medicines, or other monoclonal antibody medicines
• have or have had any type of cancer
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

This medicine may increase your risk of certain cancers by changing the way your immune system works. Ask your doctor about your risk.

Some people have thoughts about suicide while using Benlysta. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Pregnancy

It is not known if Benlysta injection or infusion will harm your unborn baby or affect its immune system. 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.

Tell your healthcare provider right away if you become pregnant during your treatment or if you think you may be pregnant. 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 or going to MotherToBaby to enroll. The purpose of this registry is to collect information about you and your baby's health. 

Breastfeeding

It may not be safe to breastfeed while using Benlysta. Ask your doctor about any risks.

How is Benlysta administered?

Benlysta can be administered intravenously (IV) or subcutaneously (SC).

Intravenous (IV) administration

When you first start Benlysta, you may be given it intravenously by a healthcare provider.

• It takes about 1 hour to receive your Benlysta infusion.
• You may need premedication before your infusion to monitor for infusion-related reactions.
• Your healthcare provider will tell you how often you should receive Benlysta, but it is usually given every 2 to 4 weeks.

Subcutaneous (SC) administration

Benlysta can be self-administered by SC injection or administered by a caregiver or healthcare provider.

• It is usually administered 1 time a week or 1 time every 2 weeks.
• Your healthcare provider will show you or your caregiver how to give the injections and review the signs and symptoms of possible allergic reactions.
• It is injected under the skin of your stomach (abdomen) or thigh
• Read the Instructions for Use that comes with Benlysta Package Insert for instructions about the right way to give your injections at home.

Benlysta may be prescribed as a single-dose autoinjector or as a single-dose prefilled syringe.

• The single-dose autoinjector can be used in adults or children aged 5 and older who weigh at least 15 kg (33 lb).

Do not inject this medicine into skin that is bruised, tender, red, or hard.

• Take the prefilled syringe or autoinjector out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose.
• Do not use if the medicine has been left at room temperature longer than 12 hours. Do not put it back into the refrigerator. Call your pharmacist for a new medicine.
• Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.
• Throw away used needles, syringes, or injection pens in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

The dose of Benlysta depends on who is receiving Benlysta (adult or child) and how it is given (IV or SC).

Intravenous Dose of Benlysta for SLE or Lupus Nephritis (Adults and Children)

• 10 mg/kg IV at 2-week intervals for the first 3 doses and then at 4-week intervals thereafter.
• Infuse over 1 hour

Subcutaneous Dose of Benlysta for SLE (Adults)

• 200 mg SC once weekly.

Subcutaneous Dose of Benlysta for SLE (Child)

• Weight greater than or equal to 40 kg: 200 mg once weekly.
• Weight 15 kg to less than 40 kg: 200 mg once every 2 weeks.

Subcutaneous Dose of Benlysta for Lupus Nephritis (Adults)

• 400 mg (two 200-mg injections) once weekly for 4 doses, then 200 mg once weekly thereafter.

What happens if I miss a dose?

If you miss your subcutaneous dose of Benlysta on your planned day, inject a dose as soon as you remember. Then, inject your next dose at your regularly scheduled time or continue dosing based on the new day injected.

Call your doctor for instructions if you miss an appointment for an intravenous infusion of Benlysta.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Benlysta?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Benlysta. The vaccine may not work as well and may not fully protect you from the disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and the nasal flu (influenza) vaccine.

What other drugs will affect Benlysta?

Other drugs may interact with belimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Research does not support using Benlysta with other biologic treatments, such as rituximab, in people with SLE because of the increased incidence of serious infections and post-injection systemic reactions.

Benlysta J Code

Benlysta J code is J0490 (Injection, belimumab, 10 mg).

Storage

Store your Benlysta autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C).

Keep the product in the original carton to protect it from light until the time of use.

Do not freeze. Do not shake. Avoid exposure to heat.

Ingredients

Active ingredient: belimumab.

Inactive ingredients (intravenous): citric acid, polysorbate 80, sodium citrate, sucrose.

Inactive Ingredients (subcutaneous): L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, polysorbate 80, sodium chloride. 

Benlysta is available as: 

• Single-dose vial (120 mg, 400 mg) lyophilized powder for reconstitution and dilution before intravenous infusion
• Single-dose prefilled syringe (200 mg/mL) for subcutaneous use
  • The single-dose prefilled syringe is for adults aged 18 years and older.
• Single-dose prefilled autoinjector (200 mg/mL) for subcutaneous use
  • The single-dose autoinjector is for adults and children aged 5 years and older. 

Manufacturer

Benlysta is manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19104.

Benlysta Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Benlysta.

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Further information

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