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Belimumab (Benlysta)

Reviewed by: HU Medical Review Board | Last reviewed: June 2023

Belimumab (Benlysta®) is a biologic drug approved for adults and children with lupus and lupus nephritis (kidney disease caused by lupus).1

Biologic means that a drug is created from a living organism using biotechnology. Biologics change how a certain body process works, altering cell actions or reactions. Belimumab changes the way a certain white blood cell works in the body of people with lupus and lupus nephritis.1

Belimumab is approved for people ages 5 and older with active, autoantibody-positive lupus who are receiving standard therapy. It is also approved for people ages 5 and older with active lupus nephritis who receive standard therapy.1

The benefits of belimumab have not been studied in people with severe active central nervous system lupus. It also has not been studied in combination with other biologics.1

What are the ingredients in belimumab?

The active ingredient is belimumab.1

How does belimumabwork?

Belimumab is a human monoclonal antibody drug that targets soluble human B lymphocyte stimulator proteins (BLyS, or BAFF and TNFSF13B). B cells are a type of white blood cell that recognize and fight germs. When a B cell finds what it thinks is a virus, bacteria, or other germs, it attacks and latches onto that foreign invader to kill it. In an autoimmune disease like lupus, these B cells mistake healthy cells for invaders.1

Belimumab does not bind to B cells directly. But it binds to BLyS, a B-cell survivor factor, which limits the survival of reactive B cells, including those that attack healthy tissue. This helps reduce the inflammation caused by lupus.1

What are the possible side effects?

The most common side effects of belimumab include:1

  • Nausea
  • Diarrhea
  • Fever
  • Stuffy or runny nose
  • Cough
  • Trouble sleeping
  • Headaches
  • Leg or arm pain
  • Depression
  • Pain or allergic reaction at the injection site

These are not all the possible side effects of belimumab. Talk to your doctor about what to expect when taking belimumab. You also should call your doctor if you have any changes that concern you when taking belimumab.

Other things to know

Before taking belimumab, tell your doctor if you:1

  • Have an infection or have infections that keep coming back
  • Have or have had a history of mental health issues, such as depression or thoughts of self-harm
  • Are receiving other biologic medicines, monoclonal antibodies, or IV infusions of cyclophosphamide
  • Have or have had any type of cancer
  • Hae recently received a vaccine or think you may need a vaccine

There is not enough information to know if belimumab is safe to take while pregnant. Talk to your doctor if you are pregnant or planning to become pregnant before or while taking belimumab.1

Before beginning treatment for lupus, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.

For more information, read the full prescribing information of belimumab.

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