About This Calculator

This content provides supporting information for the Vumerity (diroximel fumarate) Dose Calculator. The calculator is a clinical decision-support tool designed for healthcare professionals to determine the correct dosing schedule for patients with relapsing forms of multiple sclerosis (MS). It covers new patient initiation, switching from Tecfidera®, and maintenance dose verification.

Outputs Explained

The calculator provides a clear, actionable dosing schedule based on the selected patient scenario:

• New Patient (Initiation): Generates a two-week titration schedule with specific dates. It details the starting dose (231 mg twice daily for 7 days) and the transition to the maintenance dose (462 mg twice daily from day 8 onward).
• Patient Switching from Tecfidera®: Confirms that no titration is needed. It instructs to begin the standard maintenance dose of Vumerity (462 mg twice daily) the day after the last dose of Tecfidera®.
• Existing Patient (Maintenance): Displays the standard maintenance dose of 462 mg taken orally twice a day for quick verification.

How to Use the Calculator

Follow these simple steps to generate a dosing schedule:

1. Select Patient Scenario: Choose one of the three options that best describes the patient: New Patient, Patient Switching from Tecfidera®, or Existing Patient.
2. Enter Start Date (If Applicable): If you select New Patient, a date picker will appear. Select the date the patient will begin treatment.
3. Calculate: Click the “Calculate Schedule” button to generate the results. The output will be displayed instantly below the input panel.

Dosing Overview

The standard dosing for Vumerity follows a specific titration to improve tolerability, particularly to reduce the incidence of flushing.

• Starting Dose (Days 1-7): The initial dose is 231 mg taken orally twice daily.
• Maintenance Dose (Day 8 and onward): After the first 7 days, the dose is increased to the maintenance dose of 462 mg taken orally twice daily.

Vumerity capsules should be swallowed whole and can be taken with or without food. However, taking it with a high-fat, high-calorie meal should be avoided.

Switching from Tecfidera® (dimethyl fumarate)

Patients switching from Tecfidera® to Vumerity do not need to undergo the initial 7-day titration period. They can begin Vumerity at the full maintenance dose of 462 mg twice daily on the day following their last dose of Tecfidera®.

Missed Dose & Treatment Interruption

Guidance for re-initiating treatment depends on the duration of the interruption:

• Interruption of 2 weeks or less: It is generally acceptable to resume treatment at the previously established maintenance dose. Clinical judgment should be applied based on individual patient factors.
• Interruption of more than 2 weeks: Re-initiation of Vumerity should follow the original 7-day titration schedule, starting with the 231 mg twice-daily dose.

Safety Alerts & Monitoring

Before and during treatment with Vumerity, specific monitoring is required:

• Lymphocyte Counts: Obtain a complete blood count (CBC) with lymphocyte count within 6 months before starting treatment, every 6-12 months during treatment, and as clinically indicated.
• Liver Function: Obtain serum aminotransferase levels (ALT and AST) prior to initiation and during treatment as clinically indicated.
• Flushing: A common side effect. Administration with food or taking non-enteric-coated aspirin (up to 325 mg) 30 minutes prior to dosing may reduce its incidence and severity.

Refer to the full Prescribing Information for a complete list of warnings, precautions, and adverse events.

Frequently Asked Questions (FAQ)

References

1. VUMERITY® (diroximel fumarate) Prescribing Information. Biogen Inc. Silver Spring, MD: U.S. Food and Drug Administration.
2. Dosing & Administration of VUMERITY®. VumerityHCP.com. Biogen. Accessed September 2024.
3. Drugs@FDA: FDA-Approved Drugs – VUMERITY (diroximel fumarate). U.S. Food and Drug Administration.
4. Naismith RT, et al. Diroximel Fumarate (DRF) in Patients With Relapsing-Remitting Multiple Sclerosis: Final Safety and Efficacy Results From the Phase 3 EVOLVE-MS-1 Study. Multiple Sclerosis Journal. 2022;28(6):959-970. doi:10.1177/13524585211057497.