About This Dosing Guide

This content provides additional clinical context for the Benlysta SC Dosing Calculator. The calculator is designed to determine the correct subcutaneous (SC) dosing regimen for Benlysta® (belimumab) in adult patients with active Systemic Lupus Erythematosus (SLE) or active Lupus Nephritis (LN), based on FDA-approved prescribing information.

Important: This guide and the associated calculator are for the subcutaneous (SC) formulation only and do not apply to the intravenous (IV) formulation, which has a different, weight-based dosing schedule.

Outputs Explained

After making selections, the calculator provides a clear dosing regimen summary, which includes:

  • Recommended Dose: The amount of medication in milligrams (mg) for each administration period.
  • Dosing Frequency: How often the dose should be administered (e.g., once weekly).
  • Administration Details: Specific instructions, such as the number of 200 mg injections required to achieve the total recommended dose.
  • Clinical Context: A brief note explaining the rationale for the regimen based on the indication and phase of treatment.

How to Use the Calculator

Follow these steps to determine the correct dosing schedule:

  1. Select Patient Indication: Choose between Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN).
  2. Select Dosing Phase (for LN only): If LN is selected, a second field will appear. Choose "Initial / Loading Dose" for the first four weeks of therapy or "Maintenance Dose" for subsequent weekly dosing.
  3. Review the Regimen: The calculator will display the recommended dose, frequency, and administration instructions based on your inputs.

Dosing Overview

The subcutaneous dosing for Benlysta is fixed and does not depend on patient weight.

For Systemic Lupus Erythematosus (SLE):

  • The recommended dose is 200 mg once weekly administered via one subcutaneous injection.

For Lupus Nephritis (LN):

  • Loading Phase (Initial 4 weeks): The recommended dose is 400 mg once weekly for 4 doses. This is administered as two separate 200 mg subcutaneous injections.
  • Maintenance Phase (After week 4): Following the loading phase, the dose is reduced to 200 mg once weekly, administered as one subcutaneous injection.

Switching Between Formulations

Patients with SLE or LN can be transitioned from Benlysta intravenous (IV) infusion to subcutaneous (SC) injection. The first subcutaneous dose should be administered 1 to 2 weeks after the last intravenous dose. The decision to switch should be based on clinical judgment and patient preference. Always consult the full prescribing information for complete guidance.

Missed Dose Protocol

If a patient misses a scheduled subcutaneous dose, they should be instructed to administer it as soon as they remember. Following the missed dose administration, they should resume their normal weekly dosing schedule. The weekly interval should be maintained from the date the missed dose was administered. Do not administer two doses on the same day.

Safety Alerts & Considerations

Benlysta carries important safety information that healthcare providers must consider. This is not an exhaustive list. Please refer to the full Prescribing Information for complete details, including Boxed Warnings.

  • Mortality: An increased number of deaths were reported in clinical trials with Benlysta compared to placebo.
  • Serious Infections: Benlysta is an immunosuppressant and can increase the risk of developing serious, and sometimes fatal, infections.
  • Hypersensitivity and Infusion/Injection-Site Reactions: Serious and fatal reactions have occurred. The SC formulation can cause local injection site reactions.
  • Mental Health: Depression, suicidal ideation, and self-injury have been reported. Assess patients' risk for depression and suicide before and during treatment.

Frequently Asked Questions (FAQ)

1. Why is there no "Dosing Phase" option for the SLE indication?

The FDA-approved dosing regimen for subcutaneous Benlysta in SLE is a consistent 200 mg weekly dose from the start of therapy. It does not include an initial loading dose phase, unlike the regimen for Lupus Nephritis.

2. How is the 400 mg loading dose for Lupus Nephritis administered?

The 400 mg dose is administered by giving two separate 200 mg subcutaneous injections at different sites on the same day.

3. Does this calculator work for the intravenous (IV) formulation?

No. This tool is exclusively for the subcutaneous (SC) formulation. The IV formulation has a weight-based dosing regimen (10 mg/kg) and must be calculated separately.

4. Is the subcutaneous dose adjusted for patient weight?

No, the subcutaneous dose of Benlysta (200 mg or 400 mg) is a fixed dose and is not adjusted based on patient weight.

5. What happens after the 4-week loading phase for LN?

After completing four weekly doses of 400 mg, the patient transitions to the maintenance phase. The dose is then reduced to 200 mg once weekly for continued treatment.

6. Can this tool be used for pediatric patients?

The calculator's logic is based on adult dosing regimens. The subcutaneous formulation of Benlysta is approved for pediatric patients 5 years of age and older, but dosing may vary. Always consult the official Prescribing Information for pediatric dosing.

7. What is the difference between the SLE and LN maintenance dose?

There is no difference. The maintenance dose for both SLE and LN is 200 mg subcutaneously once weekly. The key difference is that the LN regimen begins with a 4-week loading phase of 400 mg weekly.

8. Where can I find the official Prescribing Information for Benlysta?

The full, official Prescribing Information can be found on the manufacturer's website or through the FDA's drug database. See the References section below for a direct link.

References

  1. BENLYSTA® (belimumab) Prescribing Information. GSK. Revised: 07/2024.
  2. FDA Drug Label for BENLYSTA (belimumab). U.S. Food and Drug Administration. Accessed August 2024.
  3. Fanouriakis A, Kostopoulou M, Alunno A, et al. 2023 EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2024;83(1):3-16.
  4. Benlysta (belimumab) for Lupus Nephritis | Dosing & Administration. Official HCP Website. GSK.
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