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Benlysta Dosing & Administration

Learn about the specific dosing, administration, scheduling and storage requirements for both subcutaneous (SC) and intravenous (IV) formulations of Benlysta. 

SC dosing gives patients the option to administer BENLYSTA at home 1

Recommended dosing for BENLYSTA SC 1

Benlysta for SC use is available as 200 mg in a 1-mL single-dose pre-filled pen.
 

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Benlysta SC storage and handling 1

  • Store in the refrigerator at  2–8°C (36–46°F)
  • Keep in the original carton until use to protect from light
  • Do not shake or freeze Benlysta
  • Avoid exposure to heat
  • Do not use or place back in the refrigerator if left at room temperature for more than 12 hours
  • Safely throw away medicine that is out of date or no longer prescribed
  • Keep out of reach of children

Benlysta IV is administered as a 1-hour infusion

Recommended dosing for Benlysta IV 1

Benlysta for IV use is available as 120 mg in a 5-mL single-dose vial and 400 mg in a 20-mL single-dose vial. 

Scheduling the first 3 doses in advance may be helpful for you and your patients 1

Administration instructions 1

  • Benlysta IV is supplied as a sterile, preservative-free, lyophilised powder for IV infusion only
    • Reconstitute and dilute using aseptic technique prior to administration
  • Diluted solution should be administered over 1 hour
    • Do not administer as an IV push or bolus
    • Total time from reconstitution to completion should not exceed 8 hours
  • Prophylactic premedication may be used to manage the risk of infusion and hypersensitivity reactions
    • IV should be administered by a healthcare provider to manage anaphylaxis
  • Slow or interrupt infusion rate if infusion reaction occurs
  • Discontinue immediately if the patient experiences a serious hypersensitivity reaction
  • Benlysta IV should not be infused concomitantly in the same IV line with other agents

For full instructions, refer to the full prescribing information for Benlysta.

Benlysta IV storage and handling 2

  • Refrigerate vials at 2–8°C (36–46°F)
  • Store vials in the original carton until use to protect from light
  • Do not freeze
  • Avoid exposure to heat
Resources for you and your patients

Patient Resources

Access & Support

Consider adding Benlysta for your appropriate patients with SLE

 

 

Benlysta IV:2

Indications:

BENLYSTA IV is indicated for reducing disease activity in patients aged 5 years and older with active autoantibody positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

Dosage:

Adults:
The recommended dosage regimen is 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter.

Children
The recommended dosage regimen for children aged 5 years and older is 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter.

Safety:

BENLYSTA is contraindicated in patients who have demonstrated anaphylaxis to BENLYSTA. BENLYSTA has not been studied in combination with other B cell targeted therapy or intravenous cyclophosphamide. Caution should be exercised if BENLYSTA is co-administered with other B cell targeted therapy or cyclophosphamide. Administration of BENLYSTA may result in infusion-related systemic reactions and hypersensitivity reactions, which can be severe or fatal. In the event of a severe reaction, BENLYSTA administration must be interrupted and appropriate medical therapy administered. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.

Adverse Events

Very common: Infections.
Common: Hypersensitivity reaction, Depression, Pyrexia, Infusion related systemic reactions.

Benlysta SC:1

Indications:

Benlysta is indicated as add-on therapy in adult patients with active, autoantibodypositive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.

Dosage:

Adults:
The recommended dose is 200 mg once weekly, administered subcutaneously. Dosing is not based on weight.

Safety:

Benlysta is contraindicated in patients with Hypersensitivity to the active substance or to any of the excipients listed in prescribing information.

In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Benlysta has not been studied in the following patient groups and is not recommended in:

  • severe active central nervous system lupus
  • severe active lupus nephritis
  • HIV
  • a history of, or current, hepatitis B or C
  • hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl)
  • a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant.

References

  1. Benlysta SC local prescribing information based on version EMA_CPI0062
  2. Benlysta IV local prescribing information based on GDS 16.

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©2020 GSK group of companies or its licensor.

PM-SA-BEL-WCNT-200011 Date of preparation: October 2020