How to manage flushing associated with Vumerity (diroximel fumarate) in multiple sclerosis patients?

Managing Flushing with Vumerity (Diroximel Fumarate)

Administer non-enteric coated aspirin (up to 325 mg) 30 minutes prior to Vumerity dosing to reduce the incidence and severity of flushing. 1

Primary Management Strategy

Aspirin pretreatment is the most effective intervention for flushing:

• Take non-enteric coated aspirin (up to 325 mg) 30 minutes before each Vumerity dose 1
• This strategy significantly reduces the incidence, severity, and number of flushing events without affecting their duration or time to first occurrence 2
• Aspirin pretreatment has no adverse effect on gastrointestinal tolerability 2

Dietary Modifications

Take Vumerity with food to help reduce flushing, but avoid high-fat, high-calorie meals:

• The meal or snack should contain no more than 700 calories and no more than 30 grams of fat 1
• Avoid co-administration with alcohol 1
• Most patients (94.1%) report no dietary changes are needed once established on therapy 3

Dosing Considerations

Start with the recommended titration schedule:

• Begin with 231 mg twice daily for the first 7 days, then increase to the maintenance dose of 462 mg (two 231 mg capsules) twice daily 1
• Temporary dosage reductions to 231 mg twice daily may be considered for individuals who do not tolerate the maintenance dosage 1
• Within 4 weeks, the recommended dosage of 462 mg twice daily should be resumed 1

Note on slow dose titration: While slow dose titration was evaluated in clinical trials, it did not demonstrate significant effects on reducing flushing events compared to standard titration 2

Expected Course and Patient Counseling

Flushing characteristics to discuss with patients:

• Flushing is one of the most common reactions, especially at therapy initiation, and typically decreases over time 1
• Events are generally mild to moderate in severity and last approximately 1 hour 2
• For most patients experiencing flushing, it initially occurs on the first day of treatment 2
• Patients should contact their healthcare provider if they experience persistent and/or severe flushing 1

When to Consider Discontinuation

Discontinue Vumerity if:

• The patient is unable to tolerate return to the maintenance dosage after temporary dose reduction 1
• The patient develops signs of anaphylaxis or angioedema (difficulty breathing, urticaria, swelling of throat and tongue), which requires immediate medical care 1

Important Safety Distinction

Diroximel fumarate demonstrates improved gastrointestinal tolerability compared to dimethyl fumarate:

• DRF has significantly lower rates of GI adverse events than DMF 4
• GI-related treatment discontinuation occurs in less than 1% of patients on DRF 3
• The improved GI profile is due to lower methanol concentrations in the small intestine during DRF metabolism 5