Understanding VUMERITY side effects
Are you and your healthcare provider considering VUMERITY® (diroximel fumarate)? If so, there are a few important topics to discuss. Keep reading to learn more about the serious and common side effects.
Understanding potential serious side effects
It’s important to tell your healthcare provider if you experience an allergic reaction to VUMERITY or any of its ingredients.
Before taking VUMERITY, it’s also important to talk with your healthcare provider about the potential serious side effects associated with it. Serious side effects of VUMERITY include:
Actor portrayal.
Allergic reactions Allergic reactions (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing).
Progressive multifocal leukoencephalopathy (PML) Progressive multifocal leukoencephalopathy (PML) is 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)
Herpes zoster infections (commonly known as shingles), including infections of the central nervous system.
Other serious infections
Decreases in your white blood cell count
Your healthcare provider should check your white blood cell count before you start VUMERITY, 6 months after starting treatment, and then every 6-12 months thereafter as they feel necessary.
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 symptoms of a liver problem during treatment, including:
- severe tiredness
- loss of appetite
- pain on the right side of your stomach
- dark or brown (tea color) urine
- yellowing of your skin or the white part of your eyes
Your healthcare provider should do a blood test before you start treatment with VUMERITY and while you’re on therapy.
Serious gastrointestinal problemsSerious gastrointestinal problems include bleeding, ulcers, blockage, and tears (perforations) 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 vomit that looks like “coffee grounds”
Understanding most common side effects
It’s important to talk with your healthcare provider about the most common side effects of VUMERITY. Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Read more about them below.
Flushing
Symptoms are usually described as redness, itching, or rash.
Stomach problems
Symptoms include nausea, vomiting, diarrhea, stomach pain, or indigestion. Stomach problems occurred most frequently in the first month and lessened thereafter. Some gastrointestinal problems can be serious. Get more information about serious side effects at the top of this page.
In a 96 week study, about 30% of the people experienced stomach problems, but they resolved in 89% of those people. Many experienced them within the first month and on average, they lasted about a week.*
*60% of people with stomach problems experienced them within the first month of treatment, which generally lasted 7.5 days.
Call your healthcare provider if you have any of these symptoms and they bother you or do not go away.
A separate analysis of stomach problems: VUMERITY compared with dimethyl fumarate
In a 5-week study, people with relapsing MS were asked to track any stomach problems. 253 people took VUMERITY and 249 people took dimethyl fumarate.†
Limitations to keep in mind
For this study, people rated the severity of their stomach issues on a scale of 0 (no issue) to 10 (extreme). Keep in mind, it can be hard to compare stomach problems. People had to report their own symptoms, and there's no widely used scale. This analysis was not planned as part of the clinical trials, so the data may not be as reliable.
Results should be looked at with caution due to the 5-week duration of the study. This data is not included in the full Prescribing Information for VUMERITY. Additional studies may be needed to confirm these findings.
More days without stomach problems
People taking VUMERITY reported 46% fewer days with stomach problems that they rated ≥2 than people taking dimethyl fumarate, and their stomach problems were generally less severe.
(1.4 days compared with 2.6 days for people taking dimethyl fumarate.)
More people stayed on VUMERITY
People were 83% less likely to stop taking VUMERITY because of stomach problems than dimethyl fumarate.
(0.8% of those taking VUMERITY stopped treatment compared with 4.8% of those taking dimethyl fumarate.)
†In week 1, people taking VUMERITY received the starter dose (231 mg pill) and a placebo pill twice a day. In weeks 2-5, they received the regular dose (two 231 mg pills) twice a day. In week 1, people taking dimethyl fumarate received the starter dose (120 mg pill) and one placebo pill twice a day. In weeks 2-5, they received the regular dose (240 mg pill) and one placebo twice a day.
