Vumerity® (diroximel fumarate) is the fumarate featured in this guide. It is also the only one of the five featured therapies taken by mouth.
Fumarates are disease-modifying therapies (DMTs) used for relapsing multiple sclerosis (RMS). The body processes these medications into an active substance called monomethyl fumarate (MMF). MMF may activate a natural defense pathway that helps cells respond to oxidative stress, which occurs when harmful, unstable molecules build up faster than cells can remove them. The exact mechanisms through which fumarates reduce inflammation and help slow the progression of MS are not fully understood.
Vumerity is a disease-modifying therapy supplied as delayed-release capsules. The delayed-release coating allows the medication to pass through the stomach before it begins to dissolve.
Before treatment, the healthcare team evaluates the following:
- Lymphocyte levels through a complete blood count
- Liver function
- Kidney function
- Current infections
- Current medications and health conditions
- Previous allergic reactions to Vumerity or dimethyl fumarate
- Pregnancy plans and breastfeeding
- Treatment risks, benefits, and alternatives
Who Can Take Vumerity?
Vumerity is approved for adults with relapsing forms of MS:
- Clinically isolated syndrome (CIS)
- Relapsing-remitting multiple sclerosis (RRMS)
- Active secondary progressive multiple sclerosis (active SPMS)
It is taken long-term to reduce future relapses and limit the development or growth of lesions detected on MRI. Vumerity does not treat a relapse that has already begun or directly relieve current MS symptoms.
How Does Vumerity Work?
After the body processes Vumerity, the medication is converted into its active form, MMF. While the exact way it works for RMS is not known, MMF may reduce inflammation and support the natural processes cells use to respond to oxidative stress.
How Is Vumerity Taken?
Vumerity is self-administered and intended for long-term use. The starting dose is one 231 mg capsule twice daily for seven days, followed by two 231 mg capsules twice daily. The capsules must be swallowed whole and not crushed, chewed, or opened.
What Does Research Show?
In a 96-week study, more than 1,000 adults with RMS received Vumerity, with 72 participants being Black. The study mainly examined its safety, side effects, and whether people could continue taking it. Relapses remained uncommon, and MRI scans showed fewer areas of inflammation by the end of the study. Because everyone received Vumerity, the results could not be compared with a placebo or another treatment.
In a separate analysis, researchers found that relapse rates among Black participants decreased by 78.2% over the duration of treatment. About 82% remained relapse-free at the end of the study, and the results were similar to those seen in non-Black participants. The researchers didn’t identify any new safety concerns specifically among Black participants.
Vumerity contains the active ingredient diroximel fumarate. Its effectiveness is based on trials showing that Vumerity provides similar exposure to the same active form (MMF) as dimethyl fumarate. In clinical trials, dimethyl fumarate reduced relapses and new or enlarging MS lesions compared with placebo.
Possible Side Effects With Fumarate Therapy
- Flushing
- Stomach pain
- Diarrhea
- Nausea
Possible Serious Side Effects
- Low lymphocyte levels and serious infections: A constant decrease in lymphocytes can make it harder for the body to fight infections. Serious infections, including shingles and other infections that usually affect patients with reduced immune protection, may occur.
- Progressive multifocal leukoencephalopathy: PML is a rare but serious brain infection. It has occurred in people taking dimethyl fumarate, which produces the same active substance as Vumerity.
- Liver injury: Vumerity may interfere with the liver’s ability to function normally. Blood tests are used to look for changes in liver function. Warning signs may include extreme energy loss, loss of appetite, pain in the upper-right abdomen, dark urine, or yellowing of the skin or eyes.
- Serious stomach or intestinal problems: Rare complications may include ulcers, bleeding, blockage, or tears in the stomach or intestines.
- Severe allergic reactions: Vumerity can cause a serious whole-body reaction called anaphylaxis or severe swelling called angioedema. These reactions may occur after the first dose or later in treatment. Trouble breathing, hives, or swelling of the face, tongue, or throat requires emergency medical treatment.
Contact your healthcare team if you develop:
- Fever or chills
- Constant cough
- Painful urination
- A painful rash or blisters
- Flushing that is severe or does not improve
- Frequent stomach pain, nausea, vomiting, or diarrhea
- Extreme energy loss or loss of appetite
- New symptoms that continue or become worse
Seek immediate medical treatment for:
- Trouble breathing
- Hives or a severe rash
- Swelling of the face, lips, tongue, or throat
- Severe or continuing stomach pain
- Severe vomiting or diarrhea
- Blood in vomit or stool
- Black, tar-like stools
- Dark urine
- Yellowing of the skin or eyes
- New or worsening weakness
- Vision changes
- Problems with balance or coordination
- Confusion, memory problems, or personality changes
During treatment, the healthcare team continues to check for:
- Changes in lymphocyte levels
- Infections
- Liver problems
- Serious stomach or intestinal symptoms
- PML symptoms
- Relapses and new or enlarging lesions on MRI
- Problems taking both daily doses consistently
Lymphocyte levels are checked six months after treatment begins and then every six to twelve months. Liver tests may be repeated when needed.
What Should You Discuss With Your Doctor?
- Why are you recommending Vumerity for my RRMS?
- How should I take each dose?
- How often will I need blood tests?
- What is my current lymphocyte level?
- Could my kidney or liver function affect this treatment?
- What can I do if flushing or stomach symptoms occur?
- Which symptoms should I report immediately?
- How will we determine whether Vumerity is reducing relapses and new or enlarging lesions?
- Could my other medications, health conditions, or pregnancy plans affect this treatment?
- Can I take Vumerity if I previously used dimethyl fumarate?
- Do I need to stop Vumerity before receiving a vaccine?
What Savings and Support Programs Are Available?
Patients with relapsing multiple sclerosis can find access to Vumerity through several program options. Some of those programs may help lower out-of-pocket medication costs for eligible patients with commercial insurance, provide assistance with insurance coverage, prior authorizations, denied claims, and financial support options, or help eligible patients who are uninsured, underinsured, or covered by government insurance explore other assistance programs. Learn more about savings and support for Vumerity.
Key Points
- Vumerity (diroximel fumarate) is the fumarate featured in this guide. It is also the only one of the five featured therapies taken by mouth.
- Vumerity is approved for adults with relapsing forms of MS, including CIS, RRMS, and active SPMS.
- The starting dose is one 231 mg capsule twice daily for seven days, followed by two 231 mg capsules twice daily.
- Vumerity should not be taken with dimethyl fumarate because both medications produce the same active substance.
- Vumerity is not recommended for patients with moderate or severe kidney problems.
- Consistently taking both daily doses is important for maintaining treatment.
This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment.