Vumerity: Uses, Dosage & Side Effects
A fumaric acid derivative for the treatment of relapsing forms of multiple sclerosis in adults, designed for improved gastrointestinal tolerability
Vumerity (diroximel fumarate) is a prescription oral medication used to treat relapsing forms of multiple sclerosis (MS) in adults. It is a prodrug of monomethyl fumarate (MMF) that works by activating the Nrf2 antioxidant pathway, helping to protect nerve cells from the inflammatory damage that characterizes MS. Vumerity was specifically developed as a next-generation fumarate therapy with improved gastrointestinal tolerability compared to its predecessor dimethyl fumarate (Tecfidera). Taken as delayed-release capsules twice daily, Vumerity has demonstrated equivalent efficacy to dimethyl fumarate in reducing MS relapses and slowing disability progression, while offering a significantly better gastrointestinal side effect profile that may improve treatment adherence in patients with relapsing MS.
Quick Facts: Vumerity
Key Takeaways
- Vumerity (diroximel fumarate) is an oral disease-modifying therapy for relapsing forms of multiple sclerosis in adults, sharing the same active metabolite (monomethyl fumarate) as dimethyl fumarate (Tecfidera) but with a significantly improved gastrointestinal tolerability profile.
- The standard dosage is 231 mg twice daily for the first 7 days (starting dose), followed by 462 mg (two capsules) twice daily as the maintenance dose. Capsules should be swallowed whole and not crushed or chewed.
- Regular blood monitoring is essential during treatment, as Vumerity can lower lymphocyte counts, potentially increasing the risk of serious infections including the rare brain infection PML (progressive multifocal leukoencephalopathy).
- The most common side effects are flushing and gastrointestinal symptoms (diarrhea, nausea, abdominal pain), which are typically most pronounced during the first month and can be reduced by taking the medication with food.
- Vumerity should be stored at or below 25°C in its original container to protect from moisture, and should not be used during pregnancy without medical consultation due to potential risks to the unborn child.
What Is Vumerity and What Is It Used For?
Vumerity contains the active substance diroximel fumarate, a fumaric acid ester that belongs to a class of medications known as immunomodulators. After oral ingestion, diroximel fumarate is rapidly converted in the body to its active metabolite, monomethyl fumarate (MMF), through the action of esterase enzymes in the gastrointestinal tract. MMF is the same active metabolite produced by the earlier drug dimethyl fumarate (marketed as Tecfidera), meaning that Vumerity and Tecfidera share the same mechanism of action and clinical efficacy profile. However, diroximel fumarate was specifically designed with a different chemical structure that produces less of the methanol byproduct responsible for the gastrointestinal irritation commonly seen with dimethyl fumarate.
Multiple sclerosis is a chronic autoimmune disease in which the body's immune system malfunctions and attacks parts of the central nervous system, including the brain, spinal cord, and optic nerves. This immune-mediated attack causes inflammation that damages the myelin sheath (the protective insulation around nerve fibers) as well as the underlying nerve fibers themselves. Over time, this damage leads to disrupted nerve signal transmission, resulting in a wide range of neurological symptoms. Relapsing forms of MS are characterized by clearly defined episodes of neurological worsening (called relapses or exacerbations) followed by periods of partial or complete recovery. The most common form is relapsing-remitting MS (RRMS), which affects approximately 85% of people initially diagnosed with MS.
The symptoms of relapsing MS vary considerably between patients depending on which areas of the central nervous system are affected. Common symptoms include walking difficulties, balance problems, visual disturbances (such as blurred vision or double vision), numbness or tingling in the limbs, fatigue, muscle weakness, spasticity, bladder dysfunction, and cognitive changes. While some symptoms may resolve completely after a relapse, others can persist and accumulate over time, leading to progressive disability. Disease-modifying therapies like Vumerity aim to reduce the frequency and severity of relapses and to slow the long-term accumulation of disability.
Vumerity is believed to exert its therapeutic effects primarily through activation of the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) antioxidant response pathway. Under normal conditions, Nrf2 is held in the cytoplasm by a protein called Keap1. When activated by monomethyl fumarate, Nrf2 is released from Keap1 and translocates to the cell nucleus, where it binds to antioxidant response elements (AREs) in DNA. This binding upregulates the transcription of numerous cytoprotective genes, including those encoding antioxidant enzymes such as heme oxygenase-1 (HO-1), NAD(P)H quinone oxidoreductase 1 (NQO1), and glutathione S-transferases. These enzymes help protect cells against oxidative stress and inflammatory damage, which are central to the pathogenesis of MS. Additionally, monomethyl fumarate has been shown to modulate immune cell function, shifting the balance away from pro-inflammatory T-helper 1 (Th1) and Th17 responses toward anti-inflammatory Th2 responses.
The pivotal clinical evidence supporting Vumerity comes from the EVOLVE-MS-1 and EVOLVE-MS-2 clinical trials. EVOLVE-MS-2 was a randomized, double-blind, head-to-head study comparing diroximel fumarate with dimethyl fumarate in patients with relapsing MS. The primary endpoint was gastrointestinal tolerability, and the study demonstrated that patients treated with diroximel fumarate experienced significantly fewer gastrointestinal adverse events, including nausea, vomiting, diarrhea, and abdominal pain, compared to those receiving dimethyl fumarate. A bioequivalence study confirmed that the exposure to the active metabolite MMF was equivalent between the two drugs, establishing that Vumerity provides the same therapeutic benefit as Tecfidera. EVOLVE-MS-1, a long-term open-label study, provided further evidence of the sustained efficacy and safety of diroximel fumarate over extended treatment periods.
Vumerity was first approved by the U.S. Food and Drug Administration (FDA) in October 2019 and subsequently received marketing authorization from the European Medicines Agency (EMA). It is now available in multiple countries worldwide as a first-line or second-line disease-modifying therapy for adults with relapsing forms of multiple sclerosis. By offering equivalent efficacy with improved tolerability, Vumerity represents an important treatment option that may improve treatment adherence and patient quality of life in the management of relapsing MS.
The primary advantage of Vumerity over its predecessor dimethyl fumarate (Tecfidera) is its significantly improved gastrointestinal tolerability. In the EVOLVE-MS-2 clinical trial, the rate of gastrointestinal adverse events leading to treatment discontinuation was substantially lower with diroximel fumarate. This is clinically meaningful because GI side effects are one of the most common reasons patients discontinue fumarate-based MS therapies, and improved tolerability can translate to better treatment adherence and long-term outcomes.
What Should You Know Before Taking Vumerity?
Contraindications
You must not take Vumerity if you are allergic (hypersensitive) to diroximel fumarate, related substances known as fumarates or fumaric acid esters, or any other ingredients in this medicine. The excipients include methacrylic acid-ethyl acrylate copolymer, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, triethyl citrate, talc, magnesium stearate, hypromellose, titanium dioxide, potassium chloride, and carrageenan. If you have experienced allergic reactions to any fumarate-containing medication in the past, you should not take Vumerity.
Vumerity is also contraindicated in patients with confirmed progressive multifocal leukoencephalopathy (PML) or in patients who are suspected of having PML. PML is a rare but serious brain infection caused by the John Cunningham (JC) virus, which can be reactivated in the setting of immunosuppression. Since Vumerity can lower lymphocyte counts and thereby compromise immune surveillance, its use is not appropriate in patients who already have or are suspected to have this infection.
Warnings and Precautions
Contact your doctor immediately if you notice new or worsening neurological symptoms such as weakness on one side of the body, clumsiness, vision changes, confusion, personality changes, or speech difficulties. These could be symptoms of PML, a rare but potentially life-threatening brain infection that has been reported with the related drug dimethyl fumarate, typically after 1 to 5 years of treatment. Also inform your partner or caregiver about your treatment, as they may notice symptoms that you are not aware of yourself.
Vumerity can affect your white blood cells, kidneys, and liver. Before you start taking Vumerity, your doctor will perform blood tests to determine your white blood cell count (particularly lymphocyte count) and to verify that your kidneys and liver are functioning properly. These tests will be repeated at regular intervals throughout your treatment. If your white blood cell count drops significantly during treatment, your doctor may consider performing additional tests or discontinuing your treatment to prevent the risk of serious infections.
Talk to your doctor before taking Vumerity if you have any of the following conditions:
- Active serious infection: such as pneumonia or other significant infections. Your doctor may advise delaying treatment until the infection has resolved.
- Severe kidney disease: Vumerity and its metabolites are partially cleared by the kidneys. A rare but serious kidney condition called Fanconi syndrome has been reported with the related drug dimethyl fumarate. Symptoms include increased urination, increased thirst and fluid intake, muscle weakness, bone fractures, or unexplained pain. Report these symptoms to your doctor promptly.
- Severe liver disease: Drug-induced liver injury and elevated liver enzymes have been reported. Your doctor will monitor liver function during treatment.
- Gastrointestinal conditions: Although Vumerity was designed for improved GI tolerability, patients with pre-existing stomach or intestinal conditions should discuss potential risks with their doctor.
Flushing (redness and warmth of the face and body) is a very common side effect. However, severe flushing accompanied by additional symptoms such as facial swelling, difficulty breathing, dizziness, or widespread rash may indicate a serious hypersensitivity (anaphylactic) reaction. If you experience these symptoms, stop taking Vumerity and seek immediate medical attention.
Herpes zoster (shingles) can occur during treatment with Vumerity. In some cases, serious complications have developed. You should immediately inform your doctor if you suspect you have symptoms of shingles, which typically include a painful, blistering rash on one side of the body or face, often preceded by burning, tingling, or itching sensations, and sometimes accompanied by fever and weakness.
Children and Adolescents
Vumerity should not be given to children and adolescents under 18 years of age. The safety and efficacy of diroximel fumarate have not been established in this age group, and there are currently no clinical data to support its use in pediatric patients. Multiple sclerosis in children and adolescents requires specialized evaluation and management by pediatric neurologists, and treatment decisions should be based on age-appropriate therapies with established safety data in younger populations.
Other Medicines and Vumerity
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor about:
- Other fumaric acid esters (fumarates): Concurrent use with other fumarate-containing products should be avoided due to the risk of additive side effects and excessive immunosuppression.
- Immunosuppressive or immunomodulatory medicines: Including chemotherapy, other disease-modifying therapies for MS, or medications that suppress the immune system. Switching from or to other MS therapies requires careful timing and monitoring of blood counts to minimize the risk of compounded immunosuppression.
- Nephrotoxic medications: Including certain antibiotics (such as aminoglycosides), diuretics, certain pain relievers (such as ibuprofen and other NSAIDs), and lithium-containing medications. These drugs can affect kidney function, and their combined use with Vumerity warrants additional monitoring.
- Live vaccines: If you receive live vaccines while taking Vumerity, you may be at increased risk of developing an infection from the vaccine. Your doctor will determine whether non-live (inactivated) vaccines should be administered instead.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using Vumerity. You should not use Vumerity during pregnancy unless you have first discussed the risks and benefits with your doctor. This is because diroximel fumarate could potentially harm the developing fetus. If you are of childbearing potential, you should use reliable methods of contraception during treatment. If you discover that you are pregnant while taking Vumerity, contact your doctor immediately to discuss next steps.
It is not known whether diroximel fumarate or its metabolites pass into breast milk. Your doctor will help you decide whether to discontinue breastfeeding or to discontinue Vumerity, taking into account the benefit of breastfeeding for the child and the benefit of therapy for you. This decision should be made on an individual basis considering the mother's clinical condition and the importance of treatment for her MS management.
Driving and Operating Machinery
Vumerity is not expected to affect your ability to drive or use machines. No studies on the effects of diroximel fumarate on driving ability or machine operation have been performed. However, based on its pharmacological properties and known side effect profile, clinically significant impairment of these abilities is unlikely. If you experience any adverse effects such as dizziness or fatigue that could impair your ability to drive or operate machinery, refrain from these activities until the symptoms resolve.
How Does Vumerity Interact with Other Drugs?
Unlike many small-molecule drugs that are metabolized by hepatic cytochrome P450 (CYP) enzymes, diroximel fumarate and its active metabolite monomethyl fumarate (MMF) are processed through esterase-mediated hydrolysis and subsequently cleared via the tricarboxylic acid (TCA) cycle, with the major elimination pathway being exhalation of carbon dioxide. This unique metabolic pathway means that traditional CYP-mediated drug-drug interactions are not expected with Vumerity. However, several important pharmacodynamic interactions and precautions should be considered.
No formal pharmacokinetic drug interaction studies have been conducted with diroximel fumarate. Based on in vitro data, MMF is not a significant inhibitor or inducer of CYP enzymes (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4) at therapeutically relevant concentrations. Additionally, MMF is not a clinically significant substrate, inhibitor, or inducer of major drug transporters such as P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting polypeptides (OATP1B1, OATP1B3), or organic cation transporters (OCT2). These findings suggest a low potential for pharmacokinetic interactions with commonly prescribed medications.
Despite the favorable pharmacokinetic interaction profile, there are several clinically relevant pharmacodynamic considerations when prescribing Vumerity alongside other medications:
| Drug Category | Examples | Interaction Risk | Recommendation |
|---|---|---|---|
| Other fumarates | Dimethyl fumarate (Tecfidera), other fumaric acid esters | Additive toxicity | Do not use concurrently |
| Immunosuppressants | Azathioprine, methotrexate, cyclosporine, fingolimod, natalizumab | Additive immunosuppression | Avoid concurrent use; washout period required when switching |
| Nephrotoxic drugs | Aminoglycosides, NSAIDs (ibuprofen, naproxen), lithium, diuretics | Increased risk of kidney damage | Monitor kidney function closely |
| Live vaccines | MMR, varicella, yellow fever, live influenza | Risk of vaccine-related infection | Avoid live vaccines; use inactivated alternatives |
| Other MS therapies | Interferon beta, glatiramer acetate, teriflunomide | Additive immune effects | Do not combine without specialist guidance |
When switching between disease-modifying therapies for MS, it is important to allow an appropriate washout period to minimize the risk of cumulative immunosuppression. The duration of the washout period depends on the half-life and mechanism of action of the previous therapy. For example, patients switching from fingolimod should wait until lymphocyte counts have recovered to normal before starting Vumerity, and patients switching from natalizumab typically require a washout of several months. Your neurologist will determine the appropriate timing based on your individual clinical circumstances and blood test results.
It is important to note that while non-live (inactivated) vaccines can generally be administered during Vumerity treatment, the immune response to these vaccines may be reduced due to the immunomodulatory effects of the medication. Your doctor may recommend checking antibody levels after vaccination to confirm an adequate immune response, particularly for important vaccinations such as influenza or COVID-19 vaccines.
Always inform your doctor, pharmacist, or MS specialist about all medications you are taking, including over-the-counter medicines, herbal supplements, and vitamins. Although Vumerity has a low potential for traditional drug-drug interactions, the primary concerns relate to additive effects on the immune system and kidneys. Maintaining open communication with your healthcare team ensures safe and effective use of Vumerity as part of your MS management plan.
What Is the Correct Dosage of Vumerity?
Vumerity should always be taken exactly as your doctor has prescribed. If you are unsure about any aspect of your dosing schedule, consult your doctor or pharmacist for clarification. The medication is available as delayed-release (enteric-coated) hard capsules, each containing 231 mg of diroximel fumarate. The delayed-release formulation is designed to reduce direct contact of the active substance with the gastric mucosa, which contributes to the improved gastrointestinal tolerability profile of Vumerity compared to dimethyl fumarate.
Adults
| Phase | Dose | Frequency | Duration |
|---|---|---|---|
| Starting dose | 231 mg (1 capsule) | Twice daily | First 7 days |
| Maintenance dose | 462 mg (2 capsules) | Twice daily | Ongoing |
The dose titration during the first week serves an important purpose: it allows your body to gradually adjust to the medication and can significantly reduce the intensity of initial side effects, particularly flushing and gastrointestinal symptoms. After the 7-day titration period, you should take the full maintenance dose of 462 mg (two capsules) twice daily. The total daily dose at maintenance is therefore 924 mg (four capsules per day, divided into two doses).
The capsules should be swallowed whole with water. Do not crush, chew, or open the capsules, and do not sprinkle the capsule contents onto food. Breaking the delayed-release coating can increase the absorption rate of the active substance and may intensify certain side effects, particularly flushing and gastrointestinal symptoms. While Vumerity can be taken with or without food, taking it with a meal (particularly one that includes some fat or protein) has been shown to reduce the incidence and severity of flushing and GI side effects during the initial weeks of treatment.
Children and Adolescents
Vumerity is not recommended for use in patients under 18 years of age due to insufficient safety and efficacy data in this population. Pediatric dosing has not been established, and the use of Vumerity in children should not be considered outside of specialized clinical trial settings.
Elderly Patients
No specific dose adjustment is required for elderly patients. However, clinical experience with Vumerity in patients over 65 years of age is limited. Elderly patients may be more susceptible to infections due to age-related immune changes, and careful monitoring of lymphocyte counts and kidney function is particularly important in this population. Your doctor will assess the appropriateness of Vumerity treatment based on your overall health status and any other medical conditions.
Missed Dose
If you forget to take a dose of Vumerity, do not take a double dose to make up for the missed one. If there are still at least 4 hours before your next scheduled dose, you can take the missed dose as soon as you remember. If there are fewer than 4 hours until your next dose, skip the missed dose entirely and take your next scheduled dose at the usual time. Missing an occasional dose is unlikely to significantly affect the overall efficacy of your treatment, but consistent adherence to the prescribed dosing schedule is important for optimal therapeutic benefit.
Overdose
If you have taken more capsules than prescribed, contact your doctor immediately. Symptoms of an overdose may include an intensification of the known side effects of Vumerity, particularly flushing, gastrointestinal symptoms (nausea, diarrhea, abdominal pain), and general malaise. There is no specific antidote for diroximel fumarate overdose. Treatment is supportive, addressing individual symptoms as they arise. In the event of a significant overdose, seek emergency medical attention.
To minimize side effects: (1) Always follow the dose titration schedule during the first week. (2) Take capsules with food, especially during the initial weeks of treatment. (3) If flushing is bothersome, taking a non-enteric-coated aspirin (325 mg) 30 minutes before your Vumerity dose may help reduce symptoms (discuss with your doctor first). (4) Try to take your doses at consistent times each day to help establish a routine. (5) Do not reduce the dose on your own without consulting your doctor.
What Are the Side Effects of Vumerity?
Like all medicines, Vumerity can cause side effects, although not everyone experiences them. Understanding the potential side effects and their frequencies can help you recognize important symptoms early and communicate effectively with your healthcare team. The side effects described below are based on clinical trial data and post-marketing surveillance reports for diroximel fumarate and its related drug dimethyl fumarate.
Serious Side Effects
Vumerity can lower your lymphocyte count (a type of white blood cell), which may increase your risk of infections, including the rare but serious brain infection PML (progressive multifocal leukoencephalopathy). PML has been reported after 1 to 5 years of treatment with the related drug dimethyl fumarate. Symptoms may resemble an MS relapse and include new or worsening weakness on one side of the body, clumsiness, vision changes, memory or thinking problems, confusion, or personality changes lasting more than a few days. Contact your doctor immediately if you notice any of these symptoms.
Although flushing is a very common and usually mild side effect, it can occasionally be accompanied by signs of a serious allergic reaction (anaphylaxis). Seek immediate medical attention if you experience flushing together with swelling of the face, lips, mouth, or tongue (angioedema), wheezing or difficulty breathing, dizziness, or loss of consciousness. Stop taking Vumerity and call emergency services immediately.
Side Effect Frequency Overview
Very Common
May affect more than 1 in 10 people
- Flushing (redness of the face or body, feeling of warmth, heat, burning, or itching)
- Diarrhea (loose stools)
- Nausea
- Abdominal pain or stomach cramps
- Ketones in urine (detected in urine tests, a natural body substance)
- Low white blood cell count (lymphopenia, leukopenia)
Common
May affect up to 1 in 10 people
- Gastroenteritis (inflammation of the intestines)
- Vomiting
- Indigestion (dyspepsia)
- Gastritis (inflammation of the stomach lining)
- Gastrointestinal disturbance
- Burning sensation
- Hot flush, feeling hot
- Itching of the skin (pruritus)
- Skin rash
- Erythema (pink or red patches on the skin)
- Hair loss (alopecia)
- Protein (albumin) in urine (proteinuria)
- Elevated liver enzymes (ALT, AST) in blood tests
Uncommon
May affect up to 1 in 100 people
- Allergic reactions (hypersensitivity)
- Decreased platelet count
Rare
May affect up to 1 in 1,000 people
- Drug-induced liver injury with elevated liver enzymes (ALT or AST combined with elevated bilirubin)
Not Known
Frequency cannot be estimated from available data
- Progressive multifocal leukoencephalopathy (PML)
- Herpes zoster (shingles) with symptoms including blisters, burning, itching, or pain on the skin
- Runny nose (rhinorrhea)
- Severe allergic reactions (anaphylaxis)
- Fanconi syndrome (rare kidney disorder)
The flushing and gastrointestinal side effects are typically most prominent during the first month of treatment and tend to decrease in frequency and severity with continued use. Taking Vumerity with food, especially during the initial weeks, can significantly reduce these symptoms. If flushing or GI symptoms are particularly bothersome, talk to your doctor, who may recommend strategies to manage them. Do not reduce your dose on your own without your doctor's guidance.
It is important to attend all scheduled blood tests during Vumerity treatment. Monitoring of your complete blood count (including lymphocyte count) and liver and kidney function tests allows your doctor to detect potential complications early, before they become clinically significant. If your lymphocyte count remains persistently low (below 0.5 × 109/L for more than 6 months), your doctor will likely reassess the appropriateness of continuing Vumerity treatment.
Contact your doctor promptly if you experience: (1) signs of infection such as persistent fever, sore throat, or unusual fatigue; (2) new or worsening neurological symptoms that could suggest PML; (3) symptoms of shingles (painful blistering rash); (4) severe flushing with swelling or breathing difficulties; (5) signs of kidney problems such as excessive thirst, frequent urination, or muscle weakness; or (6) yellowing of the skin or eyes (which may indicate liver problems).
How Should You Store Vumerity?
Proper storage of Vumerity is important to ensure the medication retains its potency and safety throughout its shelf life. The delayed-release capsules should be stored at a temperature not exceeding 25°C (77°F). Keep the capsules in the original bottle and keep the bottle tightly closed when not in use. The product is sensitive to moisture, so the desiccant included in the bottle should not be removed. Avoid transferring the capsules to a different container, such as a weekly pill organizer, for extended periods of time, as this may expose them to excess moisture.
Do not use Vumerity after the expiration date (EXP) printed on the bottle and outer carton. The expiration date refers to the last day of the indicated month. Check the expiration date before taking each dose, particularly if the bottle has been in storage for a prolonged period. Keep this medicine out of the sight and reach of children to prevent accidental ingestion.
Do not dispose of Vumerity by flushing it down the toilet or pouring it into household drains. Ask your pharmacist about the proper way to dispose of medicines that are no longer needed. Proper disposal helps protect the environment and prevents accidental exposure by others.
What Does Vumerity Contain?
The active substance in Vumerity is diroximel fumarate. Each delayed-release hard capsule contains 231 mg of diroximel fumarate. The capsule contents include the following excipients (inactive ingredients): methacrylic acid-ethyl acrylate copolymer (1:1) type A, crospovidone type A, microcrystalline cellulose, colloidal anhydrous silica, triethyl citrate, talc, and magnesium stearate. The capsule shell is composed of hypromellose, titanium dioxide (E171), potassium chloride, and carrageenan. The capsule printing ink contains black iron oxide (E172), shellac, and potassium hydroxide.
Vumerity 231 mg delayed-release hard capsules are white and printed with "DRF 231 mg" in black ink. The capsules are packaged in bottles containing either 120 or 360 (3 × 120) capsules. Not all pack sizes may be available in every market. Each bottle contains a desiccant to protect the capsules from moisture. The delayed-release (enteric-coated) formulation ensures that the active substance is released in the small intestine rather than the stomach, which contributes to the improved gastrointestinal tolerability of Vumerity compared to non-enteric-coated fumarate products.
| Component | Ingredient | Function |
|---|---|---|
| Active substance | Diroximel fumarate 231 mg | Therapeutic agent |
| Capsule fill | Methacrylic acid-ethyl acrylate copolymer, crospovidone, microcrystalline cellulose, colloidal silica, triethyl citrate, talc, magnesium stearate | Enteric coating, disintegrant, filler, flow agent, lubricant |
| Capsule shell | Hypromellose, titanium dioxide (E171), potassium chloride, carrageenan | Shell structure, opacifier, gelling agent |
| Printing ink | Black iron oxide (E172), shellac, potassium hydroxide | Capsule identification |
Frequently Asked Questions About Vumerity
Vumerity (diroximel fumarate) and Tecfidera (dimethyl fumarate) are both fumaric acid derivative medications used to treat relapsing forms of multiple sclerosis. They share the same active metabolite, monomethyl fumarate (MMF), which means they have equivalent clinical efficacy. The key difference is that Vumerity was specifically designed with a different chemical structure to improve gastrointestinal tolerability. In the EVOLVE-MS-2 clinical trial, Vumerity demonstrated significantly fewer GI side effects (nausea, vomiting, diarrhea, abdominal pain) compared to Tecfidera. This improved tolerability may help patients adhere to their treatment more consistently.
Vumerity begins to modulate the immune system shortly after starting treatment, but the clinical benefits in terms of reduced MS relapses typically become apparent over weeks to months. In clinical trials with the related drug dimethyl fumarate (which has the same active metabolite), significant reductions in relapse rates were observed within the first several months of treatment. It is important to continue taking Vumerity consistently as prescribed, even if you do not notice immediate improvements. Your neurologist will monitor your disease activity through clinical assessments and MRI scans to evaluate treatment effectiveness, typically after 6 to 12 months.
There is no specific contraindication to consuming alcohol while taking Vumerity. However, alcohol can potentially worsen some of the side effects associated with Vumerity, particularly flushing and gastrointestinal symptoms. Alcohol is also a vasodilator and may intensify flushing episodes. Additionally, both alcohol and Vumerity can affect liver function, so excessive alcohol consumption should be avoided. It is advisable to discuss your alcohol intake with your doctor and to moderate consumption, particularly during the initial weeks of treatment when side effects tend to be most pronounced.
Flushing is the most common side effect of Vumerity and typically improves over the first month of treatment. To reduce flushing: take the capsules with food (especially a meal containing fat or protein), follow the dose titration schedule during the first week, and consider taking a non-enteric-coated aspirin (325 mg) approximately 30 minutes before your Vumerity dose (with your doctor's approval). If flushing remains severe or is accompanied by symptoms such as facial swelling, difficulty breathing, or widespread hives, seek medical attention immediately as this could indicate a serious allergic reaction.
Before starting Vumerity, your doctor will perform baseline blood tests including a complete blood count (CBC) with differential (to check lymphocyte levels) and kidney and liver function tests. During treatment, these blood tests are typically repeated every 6 to 12 months, although your doctor may request more frequent monitoring depending on your individual circumstances. If your lymphocyte count drops below normal, more frequent monitoring may be required, and your doctor may consider discontinuing treatment if counts remain persistently low (below 0.5 × 109/L for more than 6 months).
Yes, switching from Tecfidera (dimethyl fumarate) to Vumerity (diroximel fumarate) is straightforward because both medications produce the same active metabolite. Patients who have been stable on Tecfidera but experience intolerable gastrointestinal side effects are common candidates for switching to Vumerity. The switch can typically be done without a washout period – you can start Vumerity the day after your last dose of Tecfidera. Since both drugs have equivalent efficacy, there is no need to restart the dose titration if you were already on the maintenance dose of Tecfidera, although your doctor may recommend titration if preferred. Discuss the switch with your neurologist to ensure it is appropriate for your situation.
References
- European Medicines Agency (EMA). Vumerity (diroximel fumarate) – Summary of Product Characteristics. Last updated 2025. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Vumerity Prescribing Information. Biogen Inc. Revised 2024. Available at: www.accessdata.fda.gov
- Naismith RT, Wundes A, Ziemssen T, et al. Diroximel fumarate demonstrates an improved gastrointestinal tolerability profile compared with dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: results from the randomized, double-blind, phase III EVOLVE-MS-2 study. CNS Drugs. 2020;34(2):185-196. doi:10.1007/s40263-020-00700-0
- Palte MJ, Wehr A, Tawa M, et al. Improving the gastrointestinal tolerability of fumaric acid esters: early findings on gastrointestinal events with diroximel fumarate in patients with relapsing-remitting multiple sclerosis from the phase 3, open-label EVOLVE-MS-1 study. Adv Ther. 2019;36(11):3154-3165. doi:10.1007/s12325-019-01085-3
- Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90(17):777-788. doi:10.1212/WNL.0000000000005347 (Updated 2023)
- Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN guideline on the pharmacological treatment of people with relapsing multiple sclerosis. Mult Scler. 2018;24(2):96-120. doi:10.1177/1352458517751049 (Updated 2024)
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- National Institute for Health and Care Excellence (NICE). Multiple sclerosis in adults: management. NICE guideline [NG220]. Published 2022, last updated 2024.
Medical Editorial Team
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