Vumerity: 7 things you should know

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Jan 4, 2024.

1. How it works

• Vumerity (diroximel fumarate) is thought to work in relapsing forms of multiple sclerosis (MS) by regulating the immune system to lower inflammation. It may also act as an antioxidant to help protect the brain and spinal cord in the central nervous system. However, the exact mechanism of action for Vumerity is not fully known.
• Vumerity has a distinct chemical structure, is a prodrug and is converted to monomethyl fumarate (MMF), the same active metabolite of dimethyl fumarate (Tecfidera).
• Vumerity is a twice-daily oral delayed-release capsule with an improved gastrointestinal (GI) profile compared to Tecfidera.
• MS is a condition in which your immune system mistakenly attacks the central nervous system (CNS), which can lead to inflammation and damage to myelin, the protective fatty covering around nerve cells. Relapsing forms of MS include: clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

2. Upsides

• Vumerity may help in multiple sclerosis (MS) in three ways: by cutting down on the number relapses, by delaying progression to disability, and by slowing down the development of brain lesions. In addition, Vumerity may also cause less stomach upset than Tecfidera.
• Stomach problems due to Vumerity treatment, such as nausea, vomiting, diarrhea, stomach pain, or indigestion, were shown to last for about one week and clear up within a month in most people who experienced these side effects.
• In a 96-week study, 30% of people had stomach trouble, but this resolved in about 90% of patients. Most stomach problems tend to occur in the first month and on average last about one week.
• In one analysis conducted by the manufacturer, people were 83% less likely to stop taking Vumerity because of stomach problems than dimethyl fumarate (Tecfidera).
• Vumerity is available as an oral capsule that you can take with or without food. Vumerity capsules can be stored at room temperature between 68°F to 77°F (20°C to 25°C) but keep away from moisture and heat. Vumerity does not require refrigeration.
• Biogen, the manufacturer of Vumerity, offers a Copay Program for commercially-insured patients who qualify. This could lower your cost to $0 per month. Biogen Support Coordinators can also help you find alternative resources for government insurance programs or other resources if you are uninsured. Contact them at 1-800-456-2255 Monday to Friday from 8:30 AM to 8 PM ET.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Common side effects like flushing / redness (40%), itching (8%), rash (8%), abdominal (stomach area) pain (18%), diarrhea (14%), indigestion (5%), nausea (12%) and vomiting (9%). Flushing and stomach problems are the most common reactions, especially during the first few weeks of therapy.
• Serious side effects like a severe allergic reaction / angioedema; PML (progressive multifocal leukoencephalopathy) a rare brain infection that can lead to death; herpes zoster infections (shingles); other serious infections; decreases in your white blood cell count; liver or stomach problems. Your doctor may need to temporarily or permanently stop treatment with Vumerity if any of these side effects occur.
• Certain simple blood tests are required before you start and during treatment to check your blood cell counts and liver. You may not be able to use this medicine if you have moderate to severe kidney problems.
• You will start with a lower dose of Vumerity during the first week to help prevent stomach upset. In the second week, you can start the normal maintenance dose, but if you have trouble tolerating the medicine your doctor can adjust your dose.
• There is no generic available for Vumerity at this time. It was first approved in October 2019 and a generic version of Vumerity is not expected until 2033. It is an expensive medicine, costing about $8,700 per month for the maintenance dose; however, most people do not pay this price. The generic name for Vumerity is diroximel fumarate.
• It is not known if Vumerity is safe and effective in children. It is not known if it will harm your unborn baby if you are pregnant, although based on animal studies, it may cause fetal harm.
• It is not known if Vumerity passes into your breast milk.
• This is not a complete list of all of the possible side effects or warnings with Vumerity. Call your doctor for medical advice about side effects or warnings.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

4. Bottom Line

Vumerity (generic name: diroximel fumarate) is an oral prescription medicine indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. It is given as a twice-daily medicine and may have fewer stomach side effects, like stomach pain, diarrhea, indigestion, nausea and vomiting, compared to Tecfidera (dimethyl fumarate).

5. Tips

• Follow any medicine directions on your package. Tell your healthcare providers about all your medical conditions, allergies, and any medicines you use, including all over-the-counter (OTC), vitamin or herbal products.
• Before you take Vumerity, tell your healthcare providers about all of your medical conditions, including: any liver, stomach or kidney problems, if you have or had low white blood cell counts or any infection; are pregnant or breastfeeding now or plan to in the future.
• The recommended starting dose on days 1 to 7 is one capsule by mouth 2 times a day. After 7 days, the recommended dose is 2 capsules by mouth 2 times a day. Try to take your medicine at about the same time each day to help stay on schedule. For example, taking two pills with breakfast and two pills with dinner may make it easier to remember.
• Vumerity is a delayed-release capsule and should be swallowed whole. Do not crush, chew, or sprinkle the capsule contents on food. Do not drink alcohol at the time you take a Vumerity dose
• Taking Vumerity with food may help to decrease flushing or redness, but avoid taking it with a high-fat, high-calorie meal or snack, which could reduce the amount of medicine that your body absorbs. Your meal or snack should contain no more than 700 calories and no more than 30 grams of fat. You do not have to take Vumerity with food, if you prefer.
• If you experience flushing that you cannot tolerate, ask your doctor if you can take a non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes before your Vumerity dose to help reduce flushing. Over-the-counter medications, like antacids, may also help relieve stomach problems, according to the manufacturer.
• Your doctor should do a blood test to check your white blood cell count before you start treatment with Vumerity and while you are on this medicine. You should have blood tests after 6 months of treatment and every 6 to 12 months after that.
• 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 this medicine.
• Do not take Vumerity if you are also taking dimethyl fumarate (Tecfidera).
• If you take too much of this medicine, call your healthcare provider, call 911 for emergency medical help, or have someone else take you to the nearest hospital emergency room right away.
• If you need a list of the inactive ingredients in Vumerity, ask your pharmacist. Vumerity is pronounced “vue mer' i tee.”
• Use this medicine exactly as your doctor prescribes it. Do not use Vumerity for a condition for which it was not prescribed. Do not give this medicine to anyone else, as it may harm them.
• Keep this medicine away from children and pets.

6. Response and effectiveness

• Studies have shown that Vumerity can lower the number of relapses, delay the progression to disability, and slow down the development of brain lesions. Vumerity may also cause less stomach upset compared to Tecfidera, another medicine used for MS.
• In one study lasting 2 years, 73% of people taking Vumerity had no relapses after 2 years, compared to 54% taking a placebo (an inactive or “fake” pill). In addition, people were less likely to relapse (27% of people taking Vumerity had a relapse vs 46% taking placebo). Overall, Vumerity reduced the number of relapses by 53% compared to placebo.
• In another 2-year study, 71% of people taking Vumerity had no relapses after 2 years, compared to 59% taking a placebo. In addition, people were less likely to relapse (34% of people taking Vumerity had a relapse compared to 41% taking placebo). Overall, Vumerity reduced the number of relapses by 44% compared to placebo.
• In the Phase 3 EVOLVE-MS-2 head-to-head study with dimethyl fumarate (Tecfidera), Vumerity met the primary endpoint of significantly fewer days of stomach side effects with intensity scores ≥2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS).
• Overall, the most common side effects reported in this Phase 3 study for both treatment groups were flushing, diarrhea and nausea (32.8%, 15.4% and 14.6% for Vumerity and 40.6%, 22.3% and 20.7% for Tecfidera, respectively). The percent of patients who discontinued the study due to stomach side effects during the five-week treatment period were 0.8% for Vumerity and 4.8% for Tecfidera.

7. Interactions

• Vumerity (diroximel fumarate) should NOT be used if you are also taking Tecfidera (dimethyl fumarate). Although they have different gemeric names, both drugs are broken down in the body to the same active medicine, monomethyl fumarate. However, if your doctor has decided you should switch, you can start Vumerity the day after you stop taking Tecfidera (dimethyl fumarate).
• Vumerity may increase your risk of serious and potentially life-threatening infections when combined with other medicines that may lower your immune system response. Talk to your doctor if you have any questions or concerns.
• Avoid taking Vumerity with a high-fat, high-calorie meal or snack, which may slow down how quickly the medicine is absorbed into your bloodstream.
• Avoid taking Vumerity with any beverage that contains alcohol (ethanol), because this could lower the amount of medicine that your body absorbs. You do not have to stop drinking alcohol altogether, just at the same time as you take this medicine.
• Ask your doctor if you need any vaccines or have your vaccine history reviewed by a healthcare professional before starting treatment. You may not be able to receive certain “live” or "live-attenuated" vaccines due to an increased risk of infection from the vaccine or a reduced vaccine response.
• Do not stop using any medications without first talking to your doctor.

Note that this list is not all-inclusive and includes only common medications that may interact with Vumerity. You should refer to the prescribing information for a complete list of interactions. Tell your doctor about all your current medicines and any medicine you start or stop using.

References

• Vumerity (diroximel fumarate) prescribing information and Medication Guide. Revised 12 /2023. Biogen. Cambridge, MA. Accessed Jan 4, 2024 at https://www.vumerity.com/content/dam/commercial/vumerity/pat/en_us/pdf/vumerity-prescribing-information.pdf

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Vumerity only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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