About This Briumvi Calculator

This clinical guide explains the key parameters and outputs of the Briumvi (ublituximab) Dosing Calculator. The information provided here is for educational purposes and is intended to supplement, not replace, the full prescribing information and professional clinical judgment. This guide covers dosing, administration, scheduling, and safety considerations based on the product label.

Outputs

After entering the date of the first infusion, the calculator provides three key outputs to support patient management and pharmacy preparation:

• Dosing Schedule: A detailed calendar showing the exact dates for the first two initial doses and the subsequent five maintenance doses, which are administered every 24 weeks.
• Preparation and Dilution Guide: Step-by-step instructions for pharmacy on how to prepare the 150 mg and 450 mg doses, including the number of vials required, volume to withdraw, and dilution in 0.9% Sodium Chloride.
• Infusion Rate Guide: A comprehensive table outlining the specific infusion rates for the 4-hour initial infusion and the standardized 1-hour rate for all subsequent infusions.

How to Use

To generate a complete Briumvi administration plan, follow these simple steps:

1. Enter the Date of First Infusion: Use the date picker to select the scheduled date for the patient’s first 150 mg dose. This is the only required input.
2. Add Optional Identifiers: You may add a patient identifier (e.g., MRN) or notes for your reference. This information is not stored or transmitted and is only for the generated printout.
3. Calculate: The tool will instantly generate the full dosing schedule and administration guides based on the initial date.

Dosing Overview

Briumvi is administered in two initial doses followed by regular maintenance doses. All doses are diluted in a 250 mL infusion bag of 0.9% Sodium Chloride Injection, USP.

Administration Schedule

Switching

When switching a patient to Briumvi from another disease-modifying therapy (DMT), consider the half-life and mechanism of action of the previous DMT to minimize potential overlapping immunosuppressive effects. The prescribing information does not provide specific washout periods, so timing should be based on clinical judgment. Initiate Briumvi after confirming that B-cell counts have returned to baseline or as deemed appropriate by the treating neurologist.

Missed Dose

If a Briumvi infusion is missed, it should be administered as soon as possible. Do not wait for the next regularly scheduled dose. The subsequent dosing schedule should be reset based on the date the missed dose was administered. For example, if a 24-week maintenance dose is given 4 weeks late, the next 24-week dose is scheduled from the date of the late administration, not the original date.

Safety Alerts

Infusion-related reactions (IRRs) are a potential risk with Briumvi. To mitigate this risk, specific pre-medication and post-infusion observation are required.

• Required Pre-medication: Administer a corticosteroid (e.g., methylprednisolone 100 mg IV), an antihistamine (e.g., diphenhydramine 25-50 mg), and an antipyretic (e.g., acetaminophen 650-1000 mg) approximately 30-60 minutes before each infusion.
• Post-Infusion Observation: Monitor the patient for at least one hour after the completion of each infusion.

Briumvi is contraindicated in patients with an active Hepatitis B virus infection. Screen all patients for HBV before initiating treatment.

FAQ

Frequently Asked Questions

• What is the standard dilution vehicle for Briumvi?
  Briumvi must be diluted in a 250 mL infusion bag of 0.9% Sodium Chloride Injection, USP.
• Can the infusion time for the first dose be shortened?
  No, the initial 150 mg dose must be administered over 4 hours with a specific rate titration to minimize the risk of infusion reactions.
• What if a patient experiences an infusion reaction?
  The infusion rate should be slowed or stopped depending on the severity of the reaction. Treatment can be resumed at a reduced rate once symptoms resolve. Refer to the full prescribing information for management guidelines.
• How is the 450 mg dose prepared?
  Three 150 mg/6 mL vials are required. A total of 18 mL (6 mL from each vial) is withdrawn and injected into the 250 mL saline bag.
• Does the calculator adjust for patient weight or age?
  No, Briumvi has a fixed dosing regimen that is not based on patient weight or age. The calculator follows this standard regimen.
• Can I use the tool to calculate a schedule for a patient who has already started therapy?
  Yes, you can use the “Missed Dose” guidance. Enter the date of the last administered dose and manually calculate the next 24-week interval.
• What is the purpose of the optional Patient Identifier field?
  It allows you to label the calculated schedule for a specific patient when printing or saving, making it easier to manage multiple patient schedules. The information is not saved by the tool.
• How long should patients be monitored after their infusion?
  Patients must be observed for at least one hour after each infusion is complete to monitor for any signs of post-infusion or hypersensitivity reactions.

References

• BRIUMVI (ublituximab) Prescribing Information. U.S. Food and Drug Administration.
• Dosing & Administration. Briumvi HCP Official Website. TG Therapeutics, Inc.
• Steinman L, Fox E, Hartung HP, et al. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2022;387(8):704-714. doi:10.1056/NEJMoa2201904. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2201904
• Briumvi (ublituximab) European public assessment report (EPAR). European Medicines Agency.