Benlysta (Belimumab) Injection

What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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  • Product Details


    Benlysta (Belimumab) is a human monoclonal antibody used to treat active systemic lupus erythematosus (SLE) and lupus nephritis. Belimumab works by blocking the B-cell activating factor (BAFF) or B-lymphocyte stimulator (BLyS), which plays a role in the survival and function of B cells. By targeting this factor, Benlysta reduces the number of abnormal B cells, helping to alleviate the symptoms of SLE and improving overall health.

    Fact Table




    US DailyMed, EU EMA



    Legal status


    Chemical Name


    Elimination half-life

    1.8 days and 19.4 days

    Dosage (Strength)

    120mg/vial, 400mg/vial


    Consult a healthcare provider for advice - might affect the baby's immune system



    Protein binding


    PubChem CID

    Not Assigned




    Not Assigned

    ATC code






    Routes of administration

    Intravenous, subcutaneous


    Benlysta is administered intravenously (IV) or subcutaneously (SQ), and the standard Benlysta dosing may vary based on the condition being treated. For adults and children with SLE or lupus nephritis, the recommended IV dose is 10 mg/kg. The infusion is given every 2 weeks for the first three doses and then every 4 weeks thereafter.

    Before using Benlysta, allow the vial to reach room temperature by leaving it out of the refrigerator for 10 to 15 minutes. The powder should then be reconstituted with Sterile Water for Injection, USP, to achieve a concentration of 80 mg/mL Belimumab.


    The active ingredient in Benlysta is Belimumab, a protein designed to target specific cells of the immune system involved in the autoimmune response. The medication comes in the form of a sterile, preservative-free, lyophilized powder, which is reconstituted and diluted before being administered through intravenous infusion.


    Avoid taking or using Benlysta if any of the following apply:

    • Benlysta has not been evaluated in patients with severe active central nervous system lupus, and its use in these cases is not recommended.
    • Benlysta has not been studied in combination with other biologic medications, and its use in these situations is not recommended.
    • Allergy or hypersensitivity to Benlysta or any of its ingredients.


    • When using Benlysta, it's important to be aware of certain cautions and warnings. Discuss the following with a healthcare provider before starting treatment:
      • Any medical conditions you have.
      • Other medications you are taking.
      • Whether you are pregnant or breastfeeding.
    • Immunosuppressive agents, including Benlysta, can lead to serious and sometimes fatal infections. Exercise caution if you have severe or chronic infections. Treatment may need to be paused if a new infection develops during Benlysta therapy.
    • Monitor for signs of new or worsening neurological symptoms indicative of progressive multifocal leukoencephalopathy (PML). If PML is confirmed, discontinue all immunosuppressant therapy, including Benlysta.
    • There is a risk of serious hypersensitivity reactions, such as anaphylaxis. Immediate medical attention should be sought if symptoms of a severe allergic reaction occur, such as hives, swelling of the face or throat, or trouble breathing.
    • Monitor for depression and suicidal thoughts before and during treatment with Benlysta. Inform your healthcare provider about any new or worsening depression or thoughts of suicide.
    • Avoid administering live vaccines with Benlysta as the immune response may be decreased. Discuss your vaccination history and any upcoming vaccinations with your healthcare provider.

    Side Effects

    Benlysta may cause side effects. Common Benlysta side effects may include nausea, diarrhea, pain in the arms or legs, and respiratory infections, such as the common cold. Some patients might also experience symptoms like insomnia, migraine, and injection site reactions.

    In addition to the common side effects, Belimumab can also result in more serious side effects that require immediate medical attention. These severe side effects may include progressive multifocal leukoencephalopathy with symptoms like memory loss, dizziness, loss of vision, and trouble talking or walking. Benlysta may also increase your risk of certain cancers. If you experience serious side effects, seek medical advice as soon as possible.


    1. Benlysta (Belimumab) Product Monograph. Durham, NC: GlaxoSmithKline; 2023.
    2. Benlysta (Belimumab) Drug Label Information. Durham, NC: GlaxoSmithKline; 2023.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 12495

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