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VUMERITY
effectiveness

Understanding the potential benefits

In clinical trials, a medication called dimethyl fumarate (DMF) was tested in people with relapsing-remitting MS. Once it’s processed in the body, VUMERITY® (diroximel fumarate) takes the same active form as DMF. The information from the clinical trials is DMF data.

Keep reading to learn how VUMERITY may be an effective relapsing MS treatment.

Two
separate studies

Each study
lasted two years

Over 1,500
people

STUDY 1
VUMERITY pill

410 people
took 240 mg of DMF twice a day
Placebo pill

408 people
took a placebo
STUDY 2
VUMERITY pill

359 people
took 240 mg of DMF twice a day
Placebo pill

363 people
took a placebo

VUMERITY is a pill that
helps in three ways

Cuts relapses
See the data
May delay disability progression
Find out more
Slows development of brain lesions
Get the details

Cuts relapses

More than 70% of people taking DMF had no relapses after two years. Reducing the risk of relapses should be one of the goals of treatment. Although no relapsing MS medication completely gets rid of relapses, DMF has been shown to reduce relapses compared with placebo.

were relapse-free

73% of people taking DMF were relapse-free after 2 years
compared with 54% of people taking placebo.

less likely to relapse

People taking DMF were 49% less likely to have a relapse
compared with placebo.*

fewer relapses

DMF cut the number of relapses by 53%
compared with placebo.†

*27% of people taking DMF had a relapse vs 46% taking placebo.
†DMF 0.172, placebo 0.364.

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were relapse-free

71% of people taking DMF were relapse-free after 2 years
compared with 59% of people taking placebo.

less likely to relapse

People taking DMF were 34% less likely to have a relapse
compared with placebo.*

fewer relapses

DMF cut the number of relapses by 44%
compared with placebo.†

*29% of people taking DMF had a relapse vs 41% taking placebo.
†DMF 0.224, placebo 0.401.

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Disability progression
was less likely

DMF was shown to delay the progression of disability, which is an important goal of treatment.

84% of patients had no disability progression
while taking DMF compared with 73% of people taking placebo.

Disability progression was 38% less likely
for people taking DMF compared with placebo.

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Disability progression was 21% less likely
13% of people taking dimethyl fumarate experienced disability progression, compared with 17% taking placebo. There was no statistically significant effect on disability progression in Study 2.

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Slows the development of
brain lesions

To understand the impact of DMF on brain lesions, researchers looked at lesions using three different MRI techniques to determine the age and stage of the lesions. Based on all three measures, people taking DMF had fewer lesions compared with those taking placebo. The link between brain lesions and the progression of relapsing MS has not been confirmed. Talking to your healthcare provider about the results of your MRI could help with the management of your relapsing MS.

ACTIVE INFLAMMATION LONG-TERM IMPACT OF INFLAMMATION POSSIBLE PERMANENT DAMAGE
AVERAGE NUMBER OVER 2 YEARS

ACTIVE INFLAMMATION

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fewer Gd+ lesions for DMF

1.8 placebo

VS

0.1 DMF

LONG-TERM IMPACT OF INFLAMMATION

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fewer T2 lesions for DMF

17.0 placebo

VS

2.6 DMF

POSSIBLE PERMANENT DAMAGE

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fewer T1 lesions for
DMF

5.6 placebo

VS

1.5 DMF
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ACTIVE INFLAMMATION LONG-TERM IMPACT OF INFLAMMATION POSSIBLE PERMANENT DAMAGE
AVERAGE NUMBER OVER 2 YEARS

ACTIVE INFLAMMATION

down arrow

fewer Gd+ lesions for DMF

2.0 placebo

VS

0.5 DMF

LONG-TERM IMPACT OF INFLAMMATION

down arrow

fewer T2 lesions for DMF

17.4 placebo

VS

5.1 DMF

POSSIBLE PERMANENT DAMAGE

down arrow

fewer T1 lesions for
DMF

7.0 placebo

VS

3.0 DMF
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More to check out

View potential common side effects ❯
Get details on switching
to VUMERITY ❯
 

Thank you for your response.

You may find it helpful to explore information about the clinical trials and effectiveness of VUMERITY® (diroximel fumarate).

 

Thank you for your response.

At this point in your journey, you may find yourself wondering about other treatment options. If so, you may find it helpful to learn more about the potential benefits of VUMERITY® (diroximel fumarate).

 

Thank you for your response.

It’s great that you’re happy with your current relapsing multiple sclerosis (MS) treatment. Should you want to consider other options in the future, you may want to learn about the potential benefits of VUMERITY® (diroximel fumarate).

 

Thank you for your response.

Even if you’re not actively looking for another treatment, it makes sense to stay informed about other options that are available to you. You may find it helpful to learn more about the potential benefits of VUMERITY® (diroximel fumarate).

 

Thank you for your response.

Reviewing available treatment options is an important step toward making an informed decision about your care. To help you in that process, here’s some information about the potential benefits of VUMERITY® (diroximel fumarate).

NEXT: Serious Side Effects

Indication and Important Safety Information

What is VUMERITY® (diroximel fumarate)?

  • VUMERITY is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

  • It is not known if VUMERITY is safe and effective in children

Important Safety Information

Do not take VUMERITY if you:

  • have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to diroximel fumarate, dimethyl fumarate, or any of the ingredients in VUMERITY

  • are taking dimethyl fumarate

Before taking and while you take VUMERITY, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems

  • have kidney problems

  • have or have had low white blood cell counts or an infection

  • are pregnant or plan to become pregnant. It is not known if VUMERITY will harm your unborn baby

    • If you become pregnant while taking VUMERITY, talk to your healthcare provider about enrolling in the BlossoMS Pregnancy Registry. You can enroll in this registry by calling 1-833-569-2635 or visiting www.blossomspregnancyregistry.com. The purpose of this registry is to monitor the health of you and your baby

  • are breastfeeding or plan to breastfeed. It is not known if VUMERITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using VUMERITY

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking VUMERITY?

  • Do not drink alcohol at the time you take a VUMERITY dose

What are the possible side effects of VUMERITY?

VUMERITY may cause serious side effects including:

  • allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking VUMERITY and get emergency medical help right away if you get any of these symptoms

  • PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months. Tell your healthcare provider right away if you get any of these symptoms of PML:

    • weakness on one side of the body that gets worse

    • clumsiness in your arms or legs

    • vision problems

    • changes in thinking and memory

    • confusion

    • personality changes

  • herpes zoster infections (shingles), including central nervous system infections

  • other serious infections

  • decreases in your white blood cell count. Your healthcare provider should do a blood test to check your white blood cell count before you start treatment with VUMERITY and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that

  • liver problems. Your healthcare provider should do blood tests to check your liver function before you start taking VUMERITY and during treatment if needed. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment

    • severe tiredness

    • loss of appetite

    • pain on the right side of your stomach

    • have dark or brown (tea color) urine

    • yellowing of your skin or the white part of your eyes

  • serious gastrointestinal problems, including bleeding, ulcers, blockage, and tears (perforation) of the stomach or intestines. Tell your healthcare provider right away if you have any of these symptoms during treatment:

    • stomach-area pain that does not go away

    • bright red or black stools (that look like tar)

    • severe vomiting

    • severe diarrhea

    • coughing up blood or blood clots

    • vomiting blood or your vomit looks like “coffee grounds”

The most common side effects of VUMERITY include:

  • flushing, redness, itching, or rash

  • nausea, vomiting, diarrhea, stomach pain, or indigestion

  • Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking VUMERITY with food (avoid high-fat, high-calorie meal or snack) may help reduce flushing. Call your healthcare provider if you have any of these symptoms and they bother you or do not go away. Ask your healthcare provider if taking aspirin before taking VUMERITY may reduce flushing

These are not all the possible side effects of VUMERITY. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Please see full Prescribing Information, including Patient Information.

 

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