Belimumab (Benlysta®) a biologic drug approved by the U.S. Food and Drug Administration (FDA) for people with lupus and lupus nephritis (kidney disease caused by lupus).1,2

Biologic means that a drug is created from a living organism using biotechnology. Biologics change the way a certain process in the body 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.1-3

Belimumab is approved for patients aged 5 years and older with active, autoantibody-positive lupus who are receiving standard therapy and adults with active lupus nephritis who are receiving standard therapy.1

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

What are the ingredients in belimumab (Benlysta)?

The active ingredient is belimumab.1

How does belimumab (Benlysta) work?

Belimumab is a human IgG1λ monoclonal antibody that targets soluble human B lymphocyte stimulator proteins (BLyS, or BAFF and TNFSF13B).1

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 in order to kill it. In an autoimmune disease like lupus, these B cells mistake healthy cells for invaders.1

Belimumab does not bind B cells directly, but by binding BLyS, a B-cell survivor factor, the drug 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 of belimumab (Benlysta)?

Possible side effects of belimumab include:1

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

More serious side effects that sometimes occur include:1

  • Infections
  • Chest pain
  • Shortness of breath
  • Suicidal thoughts, new or worsening anxiety or depression
  • Allergic reactions such as itching, rashes, dizziness, fainting, swelling of the face, lips, mouth, or throat (anaphylaxis)

These are not all the possible side effects of Benlysta. Talk to your doctor about what to expect or if you experience any changes that worry you.

Things to know about belimumab (Benlysta)

The intravenous (IV) version is approved for use in people with lupus who are ages 5 and older. The subcutaneous (under the skin) injection version is approved for people over age 18.1 People who have severe and active central nervous system involvement should not take belimumab. You also should not take it if you are currently taking another biologic drug.1

Women who wish to get pregnant should not try to conceive for at least 4 months after their last treatment.1

It is not yet known whether belimumab causes birth defects or miscarriage in pregnant women. Scientists do know that it crosses the placenta, especially in the third trimester, and impacts the immune system of fetuses and babies born to monkeys. Researchers also do not know how belimumab impacts babies fed breast milk in mothers taking the drug.1

For more information, read the full prescribing information of belimumab (Benlysta).

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Written by: Jessica Johns Pool | Last reviewed: May 2022