Vumerity (diroximel fumarate)

Vumerity generic

Vumerity is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

Vumerity side effects

Vumerity can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Vumerity. These lists do not include all possible side effects.

For more information about the possible side effects of Vumerity, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Vumerity, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Vumerity. To learn about other mild side effects, talk with your doctor or pharmacist, or view Vumerity’s prescribing information.

Mild side effects of Vumerity can include:

• flushing
• abdominal pain
• diarrhea
• nausea and vomiting
• indigestion
• rash
• itching

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Vumerity aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• progressive multifocal leukoencephalopathy (PML), which is a rare brain infection. This side effect may include symptoms such as:
  • worsening weakness on one side of the body
  • balance problems
  • problems with thinking or memory
  • changes in vision
  • personality changes
• shingles, which may include symptoms such as:
  • pain, tingling, or burning in one area of the body
  • rash on one part of the body that may blister or crust over
  • fever
  • headache
• lymphocytopenia (low levels of white blood cells called lymphocytes), which may include symptoms such as:
  • fever
  • frequent infections
• liver problems, which may include symptoms such as:
  • pain in the upper right of the abdomen
  • dark urine
  • loss of appetite
  • yellowing of the skin or eyes
• serious digestive system problems, which may include ulcers, tears, bleeding, or blockage in the intestines. These side effects can cause symptoms such as:
  • severe diarrhea, vomiting, or abdominal pain
  • vomiting bile
  • vomiting blood that looks like coffee grounds
  • passing black or tar-like stools
  • rectal bleeding

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause. To learn more about Vumerity and side effects, see this article.

Infections

In rare cases, Vumerity can cause an infection that may be serious.

Progressive multifocal leukoencephalopathy

Some people could develop progressive multifocal leukoencephalopathy (PML) while taking Vumerity. PML is a rare brain infection that can lead to severe disability or death.

Possible symptoms of PML include:

• weakness on one side of the body
• confusion or trouble remembering things
• clumsiness
• vision problems
• personality changes

In clinical studies, PML occurred in people with lymphocytopenia (low white blood cell levels). Lymphocytopenia is a possible side effect of Vumerity. (To learn more, see the “Low white blood cell level” section after.)

To watch for this side effect, your doctor should check your white blood cell level before and during your Vumerity treatment.

Shingles

Shingles infection may occur while taking Vumerity. Shingles is caused by a recurring infection with the same virus that causes chickenpox. Anyone who’s ever had chickenpox is at risk of shingles.

Shingles infection symptoms vary greatly and can include:

• mild to severe pain on one side of the body
• tingling on one side of the body
• rash that may be itchy, turn into fluid-filled blisters, and crust over
• fever or chills
• headache

Cases of shingles have been reported after Vumerity was made available to the public. However, it’s not known if Vumerity was the cause of shingles in these cases. It’s also unknown how many people have reported experiencing shingles while taking Vumerity.

Low white blood cell level

Vumerity can cause lymphocytopenia (a low level of white blood cells). Lymphocytes are immune system cells that circulate in the blood to fight infection. Lymphocytopenia could make your body unable to fight infections as well.

A blood test can be done to check your white blood cell level. Your doctor will order this blood test before you start taking Vumerity. You’ll also have this test done regularly during your treatment.

If you have any concerns about your white blood cell level, talk with your doctor.

Liver damage

Liver damage may occur in some people taking Vumerity.

Increased levels of liver enzymes can be an early sign of liver damage before any symptoms appear. Continued liver damage could possibly lead to liver failure.

A blood test that measures your liver enzyme levels is used to check for liver damage. Your doctor will order this blood test before you start treatment with Vumerity. You’ll also have this test done regularly during your treatment. If your liver enzyme levels become too high, your doctor may have you stop taking Vumerity.

Symptoms of liver damage may include fatigue, decreased appetite, right-sided abdominal pain, and jaundice (yellowing of the skin or whites of the eyes). If you have any of these symptoms during your Vumerity treatment, talk with your doctor.

Abdominal pain

Abdominal pain is a common side effect of Vumerity.

The FDA approved Vumerity based on its similarity to dimethyl fumarate (Tecfidera). Vumerity and Tecfidera have very similar side effects. However, the risk of abdominal pain (and other digestive side effects) may be different with these drugs. According to a clinical study, the risk of digestive side effects may be lower with Vumerity than with Tecfidera.

In this study, abdominal pain and digestive side effects occur most often in the first month of Vumerity treatment. For most people, these side effects become mild or go away over time.

If you experience bothersome digestive side effects during your treatment, talk with your doctor.

ALLERGIC REACTION

For some people, Vumerity oral capsule can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Vumerity oral capsule, your doctor may recommend taking a different medication instead.

Vumerity cost

As with all medications, the cost of Vumerity can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Vumerity, or if you need help understanding your insurance coverage, help is available.

Vumerity’s manufacturer, Biogen, offers support coordinators to help with questions about cost. For more information and to find out if you’re eligible for support, call 800-456-2255 or visit the program website.

Generic version:Vumerity is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

To learn more about saving money on prescriptions, check out this article. And for more information about Vumerity and cost, see this article.

Vumerity dosage

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Vumerity comes as a delayed-release oral capsule that you swallow whole. “Delayed release” means the capsule is released into your body after it passes through your stomach.

Vumerity is available in one strength: 231 milligrams (mg).

Dosage for multiple sclerosis and clinically isolated syndrome

The recommended starting dosage for Vumerity is 231 mg (one capsule) taken twice per day for 7 days.

After this, your doctor will likely increase your dosage to 462 mg (two capsules) taken twice per day. This is the recommended maintenance (long-term) dosage of Vumerity.

If you have bothersome side effects* with the maintenance dosage, your doctor may temporarily decrease your dosage back to the starting dosage. This can help your body get used to the medication. Your doctor will increase your dosage back to the maintenance dosage within 4 weeks. If you’re unable to tolerate the maintenance dosage at this stage, your doctor will likely recommend that you stop Vumerity and switch to a treatment better suited for you.

* Vumerity commonly causes flushing at the start of treatment. Flushing is likely to improve as your body adjusts to Vumerity. If you have this side effect, it may help to take Vumerity with food (see just below). If flushing continues, talk with your doctor. They may recommend taking a dose of uncoated aspirin 30 minutes before a dose of Vumerity.

About taking Vumerity

Below you’ll find information about key dosage issues.

• When to take: You should take Vumerity twice per day, once in the morning and once in the evening. Taking the medication around the same time of day helps keep a steady level of the drug in your body. This helps Vumerity work effectively.
• If you miss a dose: If you miss a dose, take it as soon as possible. But if it’s almost time for your next dose, skip the missed dose and take your next scheduled dose as usual. Do not take two doses together to make up for missing a dose.
• Taking Vumerity with food: You can take Vumerity with or without food. But if you have flushing with Vumerity, it may help to take your dose with a low calorie, low fat meal or snack. This should contain no more than 700 calories and no more than 30 grams of fat. Foods high in calories and fat can prevent your body from absorbing Vumerity, which can make the drug less effective.
• Crushing, splitting, or chewing Vumerity: You should not crush, split, or chew Vumerity. Swallow the capsule whole with a nonalcoholic drink.
• Length of use: Vumerity is meant to be used as a long-term treatment. If you and your doctor determine that Vumerity is safe and effective for you, you’ll likely take it long term.
• Length of time to work: Vumerity starts working as soon as you start taking it, but you may not notice it working. The drug helps prevent worsening symptoms of multiple sclerosis (MS) and clinically isolated syndrome (CIS), and it helps slow your condition from progressing. Talk with your doctor to learn more about how the drug works.

To learn more about Vumerity’s dosages, see this article.

Overdose

Do not take more Vumerity than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Vumerity

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Vumerity vs. Tecfidera

You may wonder how Vumerity compares with other medications that are prescribed for similar uses, such as Tecfidera. The drugs have some similarities and some differences.

Vumerity and Tecfidera are FDA approved for use in certain adults to treat relapsing-remitting multiple sclerosis (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS).

Both drugs come as a delayed-release oral capsule that is taken twice per day. (“Delayed release” means a drug is released into your body after it passes through your stomach.)

Vumerity contains the active drug diroximel fumarate. Tecfidera contains the active drug dimethyl fumarate. These drugs both belong to the Nrf2 activator drug class, so they work similarly. The active drugs are both converted by the body into an active substance called monomethyl fumarate (MMF). Then, MMF works in the body to help treat MS or CIS.

In general, Vumerity and Tecfidera are known to cause similar side effects. However, a clinical trial showed that Vumerity may be less likely to cause digestive side effects than Tecfidera.

To learn more about how Vumerity compares with Tecfidera, talk with your doctor or pharmacist. You can also refer to the prescribing information for Vumerity and Tecfidera.

Vumerity uses

The Food and Drug Administration (FDA) approves prescription drugs such as Vumerity to treat certain conditions. Vumerity may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Vumerity for multiple sclerosis

Vumerity is FDA approved to treat the following forms of multiple sclerosis (MS) in adults:

• Relapsing-remitting MS (RRMS): RRMS involves periods of relapse (when symptoms worsen) and periods of remission (when symptoms improve or go away).
• Active secondary progressive MS (SPMS): Active SPMS involves gradually worsening symptoms with no periods of remission.
• Clinically isolated syndrome (CIS): CIS is an episode of MS-like symptoms that lasts at least 24 hours. CIS may or may not develop to be MS.

With MS, your immune system attacks the protective layer around nerves in your brain and spinal cord. This prevents your nerves from communicating effectively with other parts of your body.

Symptoms of MS can vary from person to person, and they can range from mild to severe. Examples include:

• muscle weakness, stiffness, or spasms
• numbness or tingling feelings
• pain
• fatigue
• mobility problems
• vision changes, such as blurry vision or double vision
• problems with thinking or learning
• bladder or bowel problems

Vumerity is a type of MS treatment called a disease-modifying therapy (DMT).

Vumerity is used to help prevent MS relapses (periods when symptoms worsen) and to help slow the progression of your condition. The drug also helps prevent new or worsening brain lesions (areas of nerve damage in the brain that can be seen with an MRI scan). It also helps slow worsening physical symptoms of MS, such as mobility problems. To learn more about how effective Vumerity is for MS, talk with your doctor or see the drug’s prescribing information.

Vumerity may be prescribed by itself or with other drugs that treat symptoms of MS flare-ups. An example includes corticosteroids, such as prednisone (Rayos).

Vumerity and children

Vumerity is not FDA approved for any uses in children under 18 years old. The manufacturer has not studied the drug in this age group.

Vumerity interactions

Vumerity can interact with some other medications. It may also interact with certain supplements as well as certain foods.

Before taking Vumerity, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Below is a list of medications, supplements, and foods that can interact with Vumerity. This list does not contain all drugs that may interact with Vumerity. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

You shouldn’t consume alcohol at the same time as taking a dose of Vumerity. Alcohol can prevent your body from absorbing Vumerity correctly, which can make the drug less effective at treating your condition.

Additionally, it may not be safe to consume alcohol throughout treatment with Vumerity. Drinking alcohol during treatment may increase the risk and severity of certain side effects. Examples include flushing, nausea, and liver problems.

If you have questions about the safety of drinking alcohol while taking Vumerity, talk with your doctor or pharmacist.

Similar drugs

Vumerity is a disease-modifying therapy (DMT) for multiple sclerosis (MS) and clinically isolated syndrome (CIS). Other DMT drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Vumerity, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Vumerity:

• alemtuzumab (Lemtrada)
• cladribine (Mavenclad)
• dimethyl fumarate (Tecfidera)
• fingolimod (Gilenya)
• glatiramer acetate (Copaxone)
• interferon beta-1a (Rebif)
• monomethyl fumarate (Bafiertam)
• natalizumab (Tysabri)
• ocrelizumab (Ocrevus)
• ozanimod (Zeposia)
• ponesimod (Ponvory)
• siponimod (Mayzent)
• teriflunomide (Aubagio)

Things to consider when taking Vumerity

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

Vumerity and pregnancy

It’s not known whether Vumerity should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Vumerity and birth control

It’s not known if Vumerity is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Vumerity.

Vumerity and breastfeeding

It’s not known whether Vumerity should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

Common questions about Vumerity

Here are answers to some frequently asked questions about Vumerity.

Can Vumerity increase the risk of cancer?

No, Vumerity is not known to increase the risk of cancer. This side effect wasn’t reported in clinical trials of Vumerity.

Other disease-modifying therapies (DMTs) that are used to treat multiple sclerosis (MS) may increase the risk of developing certain cancers. Examples include cladribine (Mavenclad), fingolimod (Gilenya), and ocrelizumab (Ocrevus). These drugs work by reducing activity in parts of your immune system, which can make it harder for your body to find and kill cancer cells.

Although Vumerity is a type of DMT, it works differently than the drugs just mentioned. To learn more about how Vumerity works, see the following section.

Talk with your doctor if you have questions or concerns about possible risks with Vumerity.

What is Vumerity’s mechanism of action? How does it work?

Doctors don’t fully understand Vumerity’s mechanism of action, or how it works to treat certain forms of multiple sclerosis (MS) or clinically isolated syndrome (CIS).

With these conditions, your immune system attacks the protective layer around the nerves in your brain and spinal cord. This causes inflammation (swelling) that can damage nerves and cause oxidative stress (an imbalance of free radicals and antioxidants). Oxidative stress can worsen nerve damage and inflammation. This process prevents your nerves from communicating effectively with other parts of your body, which leads to symptoms of MS and CIS.

It isn’t fully understood how Vumerity works. However, one way that your body reduces oxidative stress is through a communication pathway called the Nrf2 pathway. Vumerity has been shown to activate this pathway. So it may reduce the oxidative stress that helps drive the nerve damage in MS. This may help prevent MS relapses (periods when symptoms worsen) and slow the progression of your condition.

For more information about how Vumerity works to treat your condition, talk with your doctor.