Who to Know About About Benlysta (Belimumab)

In 2011, the United States Food and Drug Administration (FDA) approved Benlysta (belimumab), the first drug licensed for use in treating lupus in over 50 years. Before then, the only drugs approved by the FDA to treat lupus were Plaquenil (hydroxychloroquine), prednisone, and aspirin.

When you hear about Benlysta, you'll often hear the word biologic. Unlike drugs created from chemical processes, a biologic is a drug that is developed from natural sources like an animal, human, or microorganism.

In addition, Benlysta is the first targeted treatment for lupus. Other drugs commonly used to treat lupus — such as Plaquenil, corticosteroids, methotrexate, azathioprine, cyclophosphamide, and mycophenolate mofetil — suppress the immune system more broadly and, as a result, tend to cause more side effects. As a target biologic, Benlysta suppresses a specific part of the immune system that plays a role in triggering lupus symptoms.

Benlysta is approved for use in adults and children aged five and older.

How Benlysta Works

A doctor checking a man's lymph nodes
FatCamera / Getty Images

Lupus, like all autoimmune diseases, is characterized by an immune system gone awry/ Benlysta is able to "calm down" the hyperactive immune response by inhibiting a protein called a B lymphocyte stimulator (BLyS) that attacks and damages the body’s own healthy tissues.

Benlysta is typically used in combination with other lupus medications. Combination therapy has shown to be more effective at decreasing lupus symptoms than using the drug in monotherapy (on its own).

Another possible benefit of Benlysta use is the reduction of corticosteroid use. This is important because the long-term use of corticosteroids is known to cause side effects like bone loss and organ damage.

Researchers studied the effects of Benlysta in people who have taken the drug for five years and have found that it is not only safe for long-term use but also does not increase the risk of side effects.


Unlike most other lupus treatments, Benlysta is not a pill. It is administered by intravenous (IV) infusion or through self-injection.

An IV infusion allows the drug to go directly into the bloodstream via a blood vessel in your arm. You cannot administer an IV infusion at home and have to go to either a doctor's office, a hospital, or an infusion center. The infusion can take about an hour, but longer if prep and/or observation time is necessary.

For the first three infusions, expect to schedule an appointment once every two weeks, and then once every four weeks after that.

The FDA approved the first self-injected Benylsta formulation in 2017. The treatment option requires a bit of training but is generally easier and more convenient than an IV.

Possible Side Effects

Like all medications, Benlysta can cause side effects. The most common Benlysta side effects include:

  • Nausea
  • Diarrhea
  • Fever
  • Stuffy or runny nose
  • Sore throat
  • Cough
  • Trouble sleeping
  • Leg or arm pain
  • Depression
  • Headache
  • Urinary tract infection
  • Decreased white blood cell count
  • Vomiting
  • Stomach pain

If you experience severe side effects, like an allergic reaction that restricts your breathing, call 911 immediately. You can also report negative side effects of Benlysta to the FDA at 1-800-FDA-1088.


While there have been women who have given birth successfully while taking Benlysta, researchers are still studying if it is safe to take Benlysta while pregnant.

Benlysta is classified as a Pregnancy Category C drug, meaning that animal studies have shown an adverse effect on the fetus but there are no adequate or well-controlled studies in humans.

With Pregnancy Category C drugs, the potential benefits of the drug may warrant use despite the potential risks.

If you become pregnant while taking Benlysta or within four months after stopping the drug, tell your rheumatologist right away. It is recommended to use contraception to prevent pregnancy while taking Benlysta and up to four months after stopping the drug.

It is unknown if the drug passes from parent to baby through breastfeeding. A parent would have to choose between breastfeeding or taking Benlysta. If you are considering breastfeeding, speak with your rheumatologist who will help you figure out your best option.


When Benlysta was first approved by the FDA, it was unclear whether the drug would benefit people with organ involvement like lupus nephritis or central nervous system (CNS) lupus.

However, in one research analysis, it was found that during the first five years of treatment with Benlysta, the drug did not cause or make organ damage worse, and could possibly slow disease progression related to organ damage.

Despite some promising research findings, Benlysta is currently not approved for the treatment of CNS lupus or lupus nephritis.

Concerns and Considerations

Because of risks associated with Benlysta, before starting the drug, tell your rheumatologist if you:

  • Have signs of or have been diagnosed with an infection, heart disease, or mental illness
  • Need or have just gotten a vaccination, especially a live vaccine
  • Have medication allergies
  • Are taking another biologic medicine, monoclonal antibodies or IV infusions of Cytoxan (cyclophosphamide)
  • Are on any other type of medication, herbal supplement, or vitamin
  • Have or have ever had any type of cancer
  • Have other medical conditions
  • Are pregnant or planning on becoming pregnant, or if you are breastfeeding

A Word From Verywell

If you are considering Benlysta, the next step is to speak with your rheumatologist. You will naturally have many questions during your initial conversation about the treatment, as well as at any point after that, including while you are taking the drug. Write down your questions as they arise, and bring your list of questions to your next appointment.

Keep in mind that it does not work as immediately as a treatment like corticosteroids. It can take weeks or months to start seeing results.

Was this page helpful?
Article Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Dubey AK, Handu SS, Dubey S, et al. Belimumab: first targeted biological treatment for systemic lupus erythematosus. J Pharmacol Pharmacother. 2011 Oct-Dec;2(4):317-9. doi:10.4103/0976-500X.85930

  2. U.S. Food and Drug Administration. Benlysta (belimumab) injection, for intravenous use. Benlysta (belimumab) subcutaneous use. Updated September 2017.

  3. Stohl W, Hilbert DM. The discovery and development of belimumab: the anti-BLyS–lupus connection. Nat Biotechnol. 2012 Jan 9;30(1):69-77. doi:10.1038/nbt.2076

  4. Bruce I, Urowitz M, Vollenhoven R, et al. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016;25(7):699-701. doi:10.1177/0961203315625119

  5. Bălănescu A, Donisan T, Bălănescu D. An ever-challenging relationship: lupus and pregnancy. Reumatologia. 2017;55(1):29-37. doi:10.5114/reum.2017.66685