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Benlysta (Generic Belimumab Injection)

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Why is this medication prescribed?

Belimumab is used with other medications to treat people with certain types of systemic lupus erythematosus (SLE or lupus; an autoimmune disease in which the immune system attacks healthy parts of the body such as joints, skin, blood vessels, and organs). Belimumab is in a class of medications called monoclonal antibodies. It works by blocking the activity of a certain protein in people with SLE. Belimumab may not work as well to treat African Americans who have SLE.

How should this medicine be used?

Belimumab comes as a powder to be mixed with sterile water and given intravenously (into a vein) over at least an hour by a doctor or nurse. It is usually given once every 2 weeks for the first three doses, and then once every 4 weeks. Your doctor will decide how often you are to receive belimumab based on your body’s response to this medication.

Belimumab may cause serious reactions during an infusion and up to a day after receiving the infusion. A doctor or nurse will watch you closely while you are receiving the infusion and after the infusion to be sure you are not having a serious reaction to the medication. You may be given other medications to treat or help prevent reactions to belimumab. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion or for up to a week after you receive the infusion: rash; itching; hives; swelling of the face, eyes, mouth, throat, tongue, or lips; difficulty breathing or swallowing; wheezing or shortness of breath; anxiousness; flushing; dizziness; fainting; headache; nausea; fever; chills; seizures; muscle aches; and slow heartbeat.

Belimumab helps control lupus but does not cure it. Your doctor will watch you carefully to see how well belimumab works for you. It may take some time before you feel the full benefit of belimumab. It is important to tell your doctor how you are feeling during your treatment.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with belimumab and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website or the manufacturer’s website to obtain the Medication Guide.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving belimumab,

  • Tell your doctor and pharmacist if you are allergic to belimumab, any other medications, or any of the ingredients in belimumab powder. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: intravenous cyclophosphamide (Cytoxan) and monoclonal antibodies or other biologic medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • Tell your doctor if you have an infection or if you have or have ever had an infection that keeps coming back, depression or thoughts of harming or killing yourself, or cancer.
  • Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving treatment with belimumab, call your doctor.
  • If you are having surgery, including dental surgery, tell the doctor or dentist that you are using belimumab.
  • Do not have any vaccinations without talking to your doctor. Tell your doctor if you have received a vaccine within the past 30 days.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you miss an appointment to receive belimumab, call your doctor as soon as possible.

What side effects can this medication cause?

Belimumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • Nausea
  • Vomiting
  • Stomach pain
  • Diarrhea
  • Headache
  • Difficulty falling asleep or staying asleep
  • Pain in the arms or legs
  • Tiredness
  • Runny nose

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately:

  • Chest discomfort or pain
  • Fever, sore throat, chills, cough, and other signs of infection
  • Thinking of harming or killing yourself or others, or planning or trying to do so
  • New or worsening depression or anxiety
  • Unusual changes in your behavior or mood
  • Acting on dangerous impulses
  • Frequent, painful, or difficult urination
  • Cloudy or strong smelling urine
  • Upper back or side pain
  • Bloody diarrhea
  • Coughing up mucus

Belimumab may increase your risk of certain cancers. Studies have shown that people who received belimumab were more likely to die from various causes than those who did not take belimumab. Talk to your doctor about the risks of receiving this medication.

Belimumab may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Your doctor will store the medication in his or her office.

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

What other information should I know?

Keep all appointments with your doctor.

Ask your doctor or pharmacist if you have any questions about belimumab.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

  • Benlysta®
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