Experience the at-home convenience of the BENLYSTA Autoinjector

In addition to IV, the BENLYSTA Autoinjector is available to address the needs of your patients 5 years and older with lupus or lupus nephritis.

AUTOINJECTOR
IV
IV = intravenous.

#1 prescribed biologic for lupus and lupus nephritis*

  • *Source: IQVIA – National Prescription Audit – Total Dispensed Rxs (NPAs TRx); Calendar Years 2019 – 2025.

BENLYSTA Autoinjector† dosing

The BENLYSTA Autoinjector is approved for SC use in patients 5 years and older with active lupus or active lupus nephritis.

BENLYSTA Autoinjector dosing for active lupus and active lupus nephritis for adult and pediatric patients

200 mg/mL single-dose prefilled autoinjector
For full instructions, refer to the full Prescribing Information for BENLYSTA.

† The autoinjector is available for patients 5 years and older. The prefilled syringe is available for adults (≥18 years) only as it has not been studied in pediatric patients less than 18 years of age.

‡ The 400-mg dose requires administration of 2 autoinjectors (2 x 200 mg). The dose is given via subcutaneous injection in the abdomen or
thigh. When the 400-mg dose is administered, it is recommended that the 2 individual 200-mg injections be administered at least 5 cm (approximately 2 inches) apart.

SC = subcutaneous.

Did you know?

76%

of adults with lupus taking BENLYSTA preferred administration with the autoinjector over intravenous infusion (follow-up survey; n=42).1,2§

  • §A follow-up survey was conducted in patients with SLE (N=43) who completed open-label, multi-dose, usability, tolerability, and safety study of subcutaneous belimumab where they were switched from IV or prefilled syringe belimumab to self-administered doses using the autoinjector for 8 weekly doses. Patients (n=42) were asked, “What is your preference for receiving BENLYSTA: using the autoinjector or IV?”
  • SLE = systemic lupus erythematosus.

Instructions for use

Watch the video below to learn how to administer the BENLYSTA Autoinjector.

    Did you know?

    99%

    of adult patients with lupus successfully administered BENLYSTA via autoinjector (open-label study; n=90).3‖

    • ‖

      Open-label study assessed the correct use of the BENLYSTA Autoinjector in adult patients with SLE (N=95). BENLYSTA was administered as a 200-mg subcutaneous injection by the patient for 8 weekly doses after being trained on proper use with the autoinjector at screening and Day 0. Successful use was determined by investigator observation and/or their review of the patient diary based on the Instructions for Use. Primary endpoint was to evaluate successful administration of observed first and second doses (Weeks 1 and 2; n/N=89/90).3

    BENLYSTA IV is available for patients when an in-office administration is more appropriate

    Recommended IV dosing in patients 5 years and older with active lupus or active lupus nephritis

    BENLYSTA IV is administered as a 1-hour infusion

    10 mg/kg is administered every 2 weeks for the first 3 doses and every 4 weeks thereafter.

    Recommended BENLYSTA IV dosing in patients 5 years or older with lupus or lupus nephritis is as follows: 10 mg/kg given on day 0, day 14, day 28 and every 4 weeks thereafter

    Scheduling first 3 doses in advance may be helpful for patients

    BENLYSTA IV is supplied as:

    • 120 mg in a 5-mL single-dose vial

    • 400 mg in a 20-mL single-dose vial

    For full instructions, refer to the full Prescribing Information for BENLYSTA.

      Did you know most of your patients may have coverage for BENLYSTA?

      See the coverage for BENLYSTA in your area

      USE THE FORMULARY TOOL

      Useful tools

      Find the vial combination that helps minimize product waste

      USE THE VIAL CALCULATOR NOW

      Calculate patients’ infusion dates

      VIEW THE INFUSION SCHEDULER

      Learn more

      Coverage & Access

      Find out if BENLYSTA is covered for patients in your local area.

      LEARN MORE ABOUT COVERAGE

      Safety profile

      Well-established safety profile based on the largest clinical trial program in lupus and lupus nephritis.

      VIEW SAFETY DATA

      Give your patients the option of at-home convenience—choose BENLYSTA today

      Indication & Safety Info

      Indication

      Important Safety Information

      Indication

      BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.

      Important Safety Information

      CONTRAINDICATION

      Previous anaphylaxis with BENLYSTA.

      WARNINGS AND PRECAUTIONS

      Serious Infections: Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.

       

      Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported. If PML is suspected, immunosuppressant therapy, including BENLYSTA, must be suspended until PML is excluded. If confirmed, stop immunosuppressant therapy, including BENLYSTA.

       

      Hypersensitivity Reactions (Including Anaphylaxis): Acute hypersensitivity reactions, including anaphylaxis and death, and infusion-related reactions have been reported. Generally, reactions occurred within hours of the infusion but may occur later, including in patients who have previously tolerated BENLYSTA. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Monitor patients during and after treatment and be prepared to manage anaphylaxis and infusion-related reactions. Be aware of the risk of hypersensitivity reactions, which may present as infusion-related reactions. Discontinue immediately in the event of a serious reaction. With intravenous administration, if an infusion reaction develops, slow or interrupt the infusion.

       

      Depression and Suicidality: Depression and suicidality were reported in patients receiving BENLYSTA. Before adding BENLYSTA, assess patients’ risk of depression and suicide and monitor them during treatment. Instruct patients/caregivers to contact their HCP if they experience new/worsening depression, suicidal thoughts/behavior, or other mood changes.

       

      Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of BENLYSTA on the development of malignancies is unknown.

       

      Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

       

      Use With Biologic Therapies: Available data do not support the safety and efficacy of concomitant use of BENLYSTA with rituximab in patients with SLE. An increased incidence of serious infections and post-injection systemic reactions in patients receiving BENLYSTA concomitantly with rituximab compared to patients receiving BENLYSTA alone has been observed. The safety and efficacy of BENLYSTA concomitantly with other biologic therapies, including B-cell-targeted therapies, have not been established. Caution should be exercised if BENLYSTA is administered in combination with other biologic therapies.

       

      ADVERSE REACTIONS

      The most common serious adverse reactions in adult SLE clinical trials were serious infections; some were fatal. The most common adverse reactions (≥5%) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (subcutaneous injection).

       

      Adverse reactions reported in clinical trials with SLE pediatric patients (≥5 years) and adult patients with lupus nephritis were consistent with those observed in adult SLE trials.

       

      USE IN SPECIFIC POPULATIONS

      Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for ≥4 months after the final treatment.

       

      Pregnancy Registry: HCPs are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/.

       

      Please see full Prescribing Information and Medication Guide for BENLYSTA.

      To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249, or
      FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

      References

      1. Data on file, GSK.

      2. Dashiell-Aje E, Harding G, Pascoe K, et al. Patient evaluation of satisfaction and outcomes with an autoinjector for self-administration of subcutaneous belimumab in patients with systemic lupus erythematosus. Patient. 2018;11(1):119-129.

      3. Sheikh SZ, Hammer AE, Fox NL, et al. Evaluation of a novel autoinjector for subcutaneous self-administration of belimumab in systemic lupus erythematosus. Int J Clin Pharmacol Ther. 2016;54(11):914-922.