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Class: Immunotherapy

Generic Name: belimumab

Trade Name: Benlysta®

For which conditions is Benlysta approved for? Benlysta is approved to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

What is the mechanism of action? Benlysta belongs to a group of drugs called monoclonal antibodies, which target, bind to, and limit the activity of certain proteins involved in disease processes. In lupus, a protein known as BLyS helps drive the activity of immune cells called B-cells. B-cells play a role in the inflammatory responses associated with lupus. By limiting the function of BLyS and thereby B-cells, Benlysta helps reduce lupus disease activity.

How is Benlysta typically given (administered)? Benlysta is given through an infusion into a vein (IV infusion). A healthcare provider will administer the infusion, which takes about one hour. Your doctor will decide how often you should receive infusions of Benlysta. Your doctor might also prescribe other medicines for you to take before you receive Benlysta to reduce your risk of a reaction to the infusion.

How are patients typically monitored? During and after the infusion, a healthcare provider will check to make sure you don’t have a bad reaction, including a severe allergic reaction (anaphylaxis). Throughout treatment, your healthcare providers will also monitor you for signs of a serious infection because Benlysta may affect the ability of your immune system to fight infection. You’ll also be asked to contact your doctor if you experience new or worsening depression, suicidal thoughts, or other mood changes.

What are some of the common (occur in 10% to 29% of patients) side effects of treatment with Benlysta?

  • Nausea
  • Diarrhea
  • Fever

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
  • Keep a list of your medicines to show to your healthcare provider and pharmacist any time you get a new medicine.
  • Tell your doctor if you are allergic to any of the ingredients in Benlysta. These include the active ingredient belimumab and inactive ingredients citric acid, polysorbate 80, sodium citrate, and sucrose.
  • Tell your doctor if you are allergic to any other medicines.
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Are there any special precautions patients should be aware of before starting treatment?

  • Tell your doctor if you think you have an infection or have infections that keep coming back. Your doctor will decide whether or not it’s safe for you to take Benlysta.
  • Tell you doctor if you have or have had mental health problems, such as depression or thoughts of suicide.
  • Tell you doctor if you have recently received a vaccination or if you think you may need a vaccination. You should not receive live vaccines during treatment with Benlysta.
  • Tell your doctor if you are receiving other biologic medicines, monoclonal antibodies, or IV infusions of the drug Cytoxan® (cyclophosphamide).
  • Tell you doctor about all of your medical conditions, including if you have or have had any type of cancer.
  • Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Benlysta will harm your unborn baby.
  • Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Benlysta passes into your breast milk. You and your healthcare provider should decide if you will receive Benlysta or breastfeed—you should not do both.

When should patients notify their physician?

Tell your doctor right away if you have any of the symptoms listed below while receiving Benlysta:

  • Symptoms of an infection, including: Fever Chills Pain or burning with urination Urinating often Bloody diarrhea Coughing up mucus
  • Symptoms of heart problems, including: Chest discomfort or pain Shortness of breath Cold sweats Nausea Dizziness Discomfort in other areas of the upper body
  • Symptoms of mental health problems and suicide, including: Thoughts of suicide or dying Attempt to commit suicide Trouble sleeping (insomnia) New or worse anxiety New or worse depression Acting on dangerous impulses Other unusual changes in your behavior or mood Thoughts of hurting yourself or others
  • Symptoms of an allergic or infusion reaction, including: Itching Swelling of the face, lips, mouth, tongue, or throat Trouble breathing Anxiousness Low blood pressure Dizziness or fainting Headache Nausea Skin rash, redness, or swelling

Tell your healthcare provider if you become pregnant during treatment with Benlysta. If you become pregnant while receiving Benlysta, your healthcare provider may suggest that you enroll in the Benlysta Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.