BENLYSTA vial calculator for IV use

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Did you know?

76%

of patients with lupus taking BENLYSTA preferred administration with the autoinjector over IV infusion.1,2*

* A follow-up survey was conducted in patients with SLE (N=43) who completed an open-label, multi-dose, usability, tolerability, and safety study of SC 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?”

IV = intravenous; SC = subcutaneous; SLE = systemic lupus erythematosus.

Find a vial combination that helps minimize waste

BENLYSTA IV comes in 2 vial sizes and is administered as a 10-mg/kg dose.

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

120 mg in a 5-mL single-dose vial

(NDC 49401-0101-01)

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

400 mg in a 20-mL single-dose vial

(NDC 49401-0102-01)

Vial calculator

Enter the weight or dose for each patient and see the results below.

† One of these fields is required.

‡ Pounds (lb) to kilograms (kg) calculated as 1 lb = 2.205 kg.

* Required fields

  • BENLYSTA IV is available as 120 mg in a 5-mL single-dose vial for injection and 400 mg in a 20-mL single-dose vial for injection, for intravenous use only.
  • The vials contain a rubber stopper not made with natural rubber latex.
  • BENLYSTA is administered as an intravenous infusion and must be reconstituted and diluted prior to administration. It is administered over 1 hour as a weight-based dose of 10 mg/kg.
  • The recommended dosage regimen is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
  • Do not administer BENLYSTA as an intravenous push or bolus.
  • Discontinue immediately in the event of a serious hypersensitivity reaction and administer appropriate medical therapy.

    Swirl, don’t shake

    Remember that when reconstituting BENLYSTA IV, you must swirl – not shake – the vial.

    • Allow the vial to sit at room temperature during reconstitution.

    • Gently swirl the vial for 60 seconds every 5 minutes until the powder is dissolved.

    Prepare the infusion

    The reconstituted BENLYSTA IV must be diluted.
    Calculate the volume required to be added to the infusion bag using this formula:

    __-mg dose ÷ 80 mg/mL =
    __ mL to be added to infusion bag

      Learn more

      BENLYSTA Autoinjector

      This option with at-home convenience is available for adult or pediatric patients with lupus or lupus nephritis.

      LEARN ABOUT THE AUTOINJECTOR

      Safety profile

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

      SEE SAFETY DATA

      Talk to your patients about the most convenient dosing option for them

      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.