Vumerity (diroximel fumarate)

What is Vumerity?

Vumerity is a brand-name prescription medication. It’s FDA-approved for use in adults with certain forms of multiple sclerosis (MS), including:

• Clinically isolated syndrome (CIS). CIS is an episode of MS-like symptoms that lasts longer than 24 hours. People with CIS don’t necessarily have MS, but it’s often the first sign of MS.
• Relapsing-remitting MS (RRMS). RRMS is the most common type of MS. With RRMS, your disease typically relapses (gets worse) and then goes into remission (a period when you don’t have symptoms).
• Active secondary progressive MS (SPMS). Active SPMS is considered a more advanced type of RRMS. With active SPMS, you may not have periods of remission. In addition, symptoms tend to get worse over time.

Vumerity comes as a capsule that you take by mouth. The capsules come in a strength of 231 milligrams (mg) and are delayed release. (A delayed-release capsule slows down the release of the drug until after it passes through the stomach. This delay protects the active drug from being destroyed by stomach acid.)

Vumerity contains the active drug diroximel fumarate.

Effectiveness

For information about the effectiveness of Vumerity, see the “Vumerity for MS” section below.

However, when taking Vumerity with meals, avoid high fat, high calorie foods. Your meal or snack shouldn’t have more than 700 calories or 30 grams (g) of fat. In addition, you should not drink alcohol at the same time you take your dose of Vumerity.

However, when taking Vumerity with meals, avoid high fat, high calorie foods. Your meal or snack shouldn’t have more than 700 calories or 30 grams (g) of fat. In addition, you should not drink alcohol at the same time you take your dose of Vumerity.

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 deal with any side effects that may be 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

Mild side effects* of Vumerity can include:

• flushing†
• skin discoloration, itching, or rash
• nausea and vomiting
• diarrhea
• abdominal pain†
• heartburn

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

* This is a partial list of mild side effects from Vumerity. To learn about other mild side effects, talk with your doctor or pharmacist, or view Vumerity’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

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 if you think you’re having a medical emergency.

Serious side effects* of Vumerity can include:

• progressive multifocal leukoencephalopathy (PML)
• shingles
• allergic reaction
• lymphocytopenia (low white blood cell level)
• increased liver enzyme levels, which can be an early sign of liver damage

* For more information about the side effects in this list, see “Side effect details” below.

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.

Note: Side effect information for Vumerity is based on clinical studies of dimethyl fumarate (Tecfidera). Tecfidera and Vumerity are broken down into the same substance by your body. Therefore, side effects are expected to be similar for these two drugs.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Vumerity. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction called anaphylaxis is rare but possible. Symptoms of anaphylaxis can include:

• swelling of the throat or tongue
• hives (raised, itchy bumps on the skin)
• trouble breathing

Angioedema is also a rare but serious symptom of an allergic reaction to Vumerity. With angioedema, sudden swelling occurs under your skin, typically in the eyelids, face, and lips.

Anaphylaxis and angioedema can happen with Vumerity after the first dose or at any time during treatment. It isn’t known how often these reactions may have occurred in clinical studies.

Call your doctor right away if you have an allergic reaction to Vumerity, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

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 below.)

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 for 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.

Clinical studies have shown that the average lymphocyte level decreased by about 30% during the first year of treatment with the drug. After that, the average level stayed the same.

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.

In clinical studies, increases in a type of liver enzyme called aspartate aminotransferase (AST) occurred in:

• 4% of people taking the drug
• 2% of people who took a placebo (a treatment with no active drug)

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.

Flushing

Flushing is the most common side effect of Vumerity. With flushing, blood vessels under the skin’s surface become briefly dilated (enlarged). This may cause warmth, itchiness, or discoloration of the face and neck.

In clinical studies, flushing occurred in:

• 40% of people taking the drug
• 6% of people who took a placebo

For most people who experience this side effect, flushing is mild to moderate and goes away over time. For others, flushing can be severe.

In clinical studies, 3% of people taking the drug had to stop treatment due to severe flushing. It’s not known how many people taking a placebo may have stopped treatment due to flushing.

If your Vumerity treatment causes flushing, taking your dose with food may reduce this side effect. A low calorie, low fat snack will slightly slow the drug’s absorption into your system, which eases flushing.

If you take your Vumerity dose with food, it’s important that your meal or snack doesn’t have more than 700 calories or 30 grams (g) of fat. High fat, high calorie foods can block the drug from being absorbed. This can make Vumerity less effective.

Taking uncoated aspirin (a dose of up to 325 milligrams [mg]) 30 minutes before taking Vumerity can also help reduce or prevent flushing. Talk with your doctor about whether it’s safe for you to take aspirin.

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 of 502 adults with MS, people were randomly divided into two groups. For 5 weeks, one group received Vumerity and the other group received Tecfidera. During the study, the participants recorded any side effects in a diary.

The results showed that:

• 34.8% of adults who took Vumerity had digestive problems
• 49% of adults who took Tecfidera had digestive problems

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.

Vumerity vs. Tecfidera

You may wonder how Vumerity compares with other medications that are prescribed for similar uses. Here we look at how Vumerity and Tecfidera are alike and different.

Ingredients

Vumerity contains the active drug diroximel fumarate. Tecfidera contains the active drug dimethyl fumarate.

Uses

Both Vumerity and Tecfidera are FDA-approved to treat certain forms of multiple sclerosis (MS), including:

• Clinically isolated syndrome (CIS). CIS is an episode of MS-like symptoms lasting longer than 24 hours.
• Relapsing-remitting MS (RRMS). RRMS is the most common type of MS. With RRMS, your disease typically relapses (gets worse) and then goes into remission (a period when you don’t have symptoms).
• Active secondary progressive MS (SPMS). Active SPMS is considered a more advanced type of RRMS. With active SPMS, you may not have periods of remission. In addition, symptoms tend to get worse over time.

Note: Vumerity and Tecfidera should not be taken together because the body breaks down these drugs into the same substance, monomethyl fumarate (MMF). Too much of this substance in your body could raise your risk for side effects. See the “Vumerity precautions” section below to learn more about safely switching from Tecfidera to Vumerity.

Drug forms and administration

Vumerity and Tecfidera both come as capsules that you take by mouth. Both drugs are taken twice a day, in the morning and evening.

Both Tecfidera and Vumerity may be taken with or without food. However, taking these medications with food can help reduce flushing, which is a side effect of both drugs.

If you take your Vumerity dose with food, it’s important that your meal or snack doesn’t have more than 700 calories or 30 grams (g) of fat. For more information about taking Vumerity with food, see the “How to take Vumerity” section below.

Side effects and risks

After being absorbed, the body converts Vumerity and Tecfidera into the same substance, MMF. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

This list contains up to 10 of the most common mild side effects that can occur with both Vumerity and Tecfidera.

• Can occur with both Vumerity and Tecfidera:
  • flushing
  • skin discoloration, itching, or rash
  • nausea and vomiting
  • diarrhea
  • abdominal pain
  • heartburn

Serious side effects

This list contains examples of serious side effects that can occur with bothVumerity and Tecfidera.

• progressive multifocal leukoencephalopathy (PML), a rare but serious infection
• increased liver enzyme levels, which can be an early sign of liver damage
• shingles
• allergic reaction
• severe flushing

Effectiveness

Vumerity and Tecfidera’s effectiveness hasn’t been directly compared in clinical studies. However, studies have found both Vumerity and Tecfidera to be effective for treating MS.

The Food and Drug Administration (FDA) based its approval of Vumerity on the fact that after being absorbed, Vumerity and Tecfidera are converted into the same substance, monomethyl fumarate (MMF). Therefore, Vumerity and Tecfidera are considered to be similarly effective for treating MS.

Costs

The price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Vumerity is a brand-name drug. There is currently no generic form of Vumerity. A generic drug is an exact copy of the active drug in a brand-name medication. Brand-name medications usually cost more than generics.

Tecfidera is a brand-name drug that contains the active drug dimethyl fumarate. This active drug is also available as a generic medication.

Alternatives to Vumerity

Other drugs are available that can treat multiple sclerosis (MS) as well as clinically isolated syndrome (CIS).*

Some drugs 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.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

Alternatives for MS

There are many FDA-approved medications for different forms of MS or CIS. Examples of other drugs that may be used to treat MS or CIS include:

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

* CIS is a condition that causes MS-like symptoms.

Vumerity dosage

The following information describes dosages that are commonly 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 is a delayed-release capsule that’s taken by mouth. It comes in a strength of 231 milligrams (mg). A delayed-release capsule slows down the release of the drug until after it passes through the stomach. This delay protects the active drug from being destroyed by stomach acid.

Dosage for MS

The starter dosage for Vumerity is one 231-mg capsule taken twice per day for the first 7 days. Then your dosage will likely be increased to the regular dose of two 231-mg capsules taken twice per day.

If you have bothersome side effects, the regular dosage can be temporarily reduced to one capsule (231 mg) taken twice per day. The regular dosage (two capsules taken twice daily) should be restarted within 4 weeks. If you can’t tolerate the regular dosage at this point, you may need to end your Vumerity treatment.

What if I miss a dose?

It’s important to take Vumerity exactly as prescribed by your doctor.

If you miss a dose, take it as soon as you remember. However, if it’s almost time for your next dose, just skip the missed dose. Then take your next dose at its scheduled time. You should not take two doses at once to make up for a missed dose. This could raise your risk for side effects.

Taking Vumerity at mealtimes can help you remember to take your doses. Consider taking your morning dose with breakfast and your evening dose with a bedtime snack.

However, when taking Vumerity with meals, avoid high fat, high calorie foods. Your meal or snack shouldn’t have more than 700 calories or 30 grams (g) of fat. In addition, you should not drink alcohol at the same time you take your dose of Vumerity.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

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.

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.

Keep in mind that you may be able to get a 90-day supply of Vumerity. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

It’s important to note that you’ll have to get Vumerity at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Vumerity, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Vumerity, contact your insurance company.

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.

Biogen, the manufacturer of Vumerity, offers Biogen support coordinators who are available to help you with questions related to the cost of Vumerity. For more information and to find out if you’re eligible for financial assistance, call 800-456-2255 or visit the program website.

Mail-order pharmacies

Vumerity may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Vumerity, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online specialty pharmacy options.

Generic version

Vumerity isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

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 drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Vumerity contains the active drug diroximel fumarate.

Vumerity for MS

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

Vumerity is FDA-approved for use in adults with certain forms of multiple sclerosis (MS), including:

• Clinically isolated syndrome (CIS). CIS is an episode of MS-like symptoms lasting at least 24 hours. People with CIS don’t necessarily have MS, but it’s often the first sign of MS.
• Relapsing-remitting MS (RRMS). RRMS is the most common type of MS. With RRMS, your disease typically relapses (gets worse) and then goes into remission (a period when you don’t have symptoms).
• Active secondary progressive MS (SPMS). Active SPMS is considered a more advanced type of RRMS. With active SPMS, you may not have periods of remission. In addition, symptoms tend to get worse over time.

About MS

MS is a disease of the central nervous system (CNS), which includes the brain and spinal cord.

It’s not known what causes MS, but it’s thought to be an autoimmune disease. With autoimmune diseases, your immune system seems to mistakenly attack healthy tissues like it would bacteria or viruses.

With MS, your immune system attacks the myelin sheath, a protective layer that surrounds nerve cells. This causes inflammation (swelling and damage), which creates oxidative stress. Oxidative stress, in addition to a damaged myelin sheath, may cause many MS symptoms.

MS symptoms may be mild to severe. Some examples include:

• fatigue
• vision problems such as double or blurred vision
• feelings of numbness or tingling (“pins and needles”)
• muscle weakness

Effectiveness for MS

The FDA based its approval of Vumerity on its similarity to dimethyl fumarate (Tecfidera). After being absorbed, the body breaks down both Vumerity and dimethyl fumarate into the same substance. Therefore, Vumerity and dimethyl fumarate are expected to be similarly effective.

Two clinical studies, each lasting 2 years, looked at how effective dimethyl fumarate is for MS. More than 1,500 people with relapsing-remitting multiple sclerosis (RRMS) were randomly chosen to either receive dimethyl fumarate or a placebo. (A placebo is a treatment with no active drug.)

These studies found that dimethyl fumarate was more effective than a placebo in three areas of MS treatment:

• Reducing the risk of relapses. Relapses are flare-ups of MS symptoms.
  • 27% to 29% of the people who took dimethyl fumarate had a relapse
  • 41% to 46% of people who took a placebo had a relapse
• Delaying the worsening of physical disability.
  • 13% to 16% of the people who received dimethyl fumarate had worsening of physical disability
  • 17% to 27% of people who received a placebo had worsening of physical disability
• Slowing the growth of brain lesions. MRI scans can be used to check for brain lesions. New or worsening brain lesions may be a sign of worsening MS.
  • 27% to 45% of people taking dimethyl fumarate had no new or newly enlarged brain lesions
  • 12% to 27% of people taking a placebo had no new or newly enlarged brain lesions

Vumerity and children

Vumerity isn’t approved for use in children. It isn’t known if Vumerity is safe or effective for children. Keep Vumerity (and all medications) where children can’t reach them.

How Vumerity works

Vumerity is approved to treat certain forms of multiple sclerosis (MS). The drug is also approved to treat clinically isolated syndrome (CIS), which is a condition that causes MS-like symptoms. (Because MS and CIS affect your body in similar ways, these conditions are often discussed together as “MS.”)

About MS

It’s not known what causes MS, but it’s thought to be an autoimmune disease. With autoimmune diseases, your immune system mistakenly attacks healthy tissues like it would bacteria or viruses.

With MS, your immune system attacks the protective covering around your nerve cells, called the myelin sheath. This causes inflammation (swelling and damage), which creates oxidative stress. Oxidative stress can contribute to the myelin sheath damage that causes many symptoms of MS. Researchers are still trying to learn exactly how and why this occurs.

What Vumerity does

The cause of MS isn’t fully understood. Therefore, the mechanism of action (how Vumerity works to treat the condition) isn’t completely clear. However, Vumerity is thought to treat MS by activating nuclear factor (erythroid-derived 2)-like 2 (Nrf2). This is a cell signal that affects how cells respond to oxidative stress. Nrf2 may help reduce damage caused by inflammation and oxidative stress.

Vumerity also affects another part of the immune system called nicotinic acid receptors. These receptors may contribute to the body’s natural anti-inflammatory processes, which could help reduce MS symptoms.

How long does it take to work?

Vumerity begins to work in your body shortly after you take your dose. However, it may take several weeks before you notice your MS symptoms being relieved or that you’re having fewer relapses (when your condition gets worse).

If you have questions about when you should expect to see your condition improve, talk with your doctor.

Vumerity and alcohol

You should not drink alcohol at the same time that you take your Vumerity dose. Clinical studies show that alcohol may reduce how much Vumerity your body absorbs. This could make the drug less effective.

Alcohol could also raise your risk for certain side effects of Vumerity, such as flushing, vomiting, and liver damage.

If you drink alcohol, talk with your doctor about how much is safe for you to drink during your Vumerity treatment.

Vumerity interactions

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

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Vumerity and other medications

Below is a medication that can interact with Vumerity. This article does not contain all drugs that may possibly interact with Vumerity.

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 use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Vumerity and dimethyl fumarate (Tecfidera)

Vumerity and Tecfidera should not be taken together because the body converts these drugs into the same substance, monomethyl fumarate (MMF). Too much MMF could raise your risk for side effects.

If your doctor is switching you from Tecfidera, start taking Vumerity the day after you stop taking Tecfidera. You should not take Tecfidera and Vumerity within the same day.

Vumerity and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Vumerity. However, you should still check with your doctor or pharmacist before using any of these products while taking Vumerity.

Vumerity and food or beverages

Vumerity isn’t known to interact with any specific foods.

Vumerity capsules may be taken with or without food. However, if you take your Vumerity dose with food, it’s important that your meal or snack doesn’t have more than 700 calories or 30 grams (g) of fat. Taking Vumerity with high fat, high calorie foods can block the drug from being absorbed. This can make Vumerity less effective.

If you have any questions about eating certain foods with Vumerity, talk with your doctor.

If you drink alcohol, you should not drink it at the same time you take your dose of Vumerity. For more details, see the “Vumerity and alcohol” section above.

How to take Vumerity

You should take Vumerity according to your doctor’s or another healthcare professional’s instructions.

When to take

Vumerity is taken twice daily, usually in the morning and in the evening.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Vumerity with food and beverages

Vumerity capsules may be taken with or without food.

If your Vumerity treatment causes flushing, taking your dose with food may reduce this side effect. A low calorie, low fat snack will slightly slow the drug’s absorption into your system, which eases flushing.

If you take your Vumerity dose with food, it’s important that your meal or snack has no more than 700 calories or 30 grams (g) of fat. High calorie, high fat foods can block the drug from being absorbed. This can make Vumerity less effective.

If you drink alcohol, you should not drink it at the same time you take your dose of Vumerity. For more details, see the “Vumerity and alcohol” section above.

Can Vumerity capsules be crushed, opened, or chewed?

Vumerity capsules should not be crushed, chewed, or opened. Swallow the capsules whole. If you have trouble swallowing Vumerity capsules, talk with your doctor or pharmacist.

Vumerity and pregnancy

It isn’t known if Vumerity is safe to take while pregnant. Clinical studies haven’t been done to look at the effects of Vumerity during pregnancy.

Animal studies show that Vumerity may have harmful effects on fetal development. However, animal studies don’t always predict what will happen in humans.

If you are pregnant or are planning a pregnancy, talk with your doctor before taking Vumerity.

Vumerity and birth control

It’s not known if Vumerity is safe to use 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.

For more information about taking Vumerity during pregnancy, see the “Vumerity and pregnancy” section above.

Vumerity and breastfeeding

It’s not known if Vumerity is safe to take while breastfeeding. This is because it’s unknown whether the drug passes into breast milk. The effects of Vumerity on breastfed children also haven’t been evaluated.

Before taking Vumerity, let your doctor know if you’re breastfeeding or planning to breastfeed.

Common questions about Vumerity

Here are answers to some frequently asked questions about Vumerity.

Will Vumerity cure my condition?

No, Vumerity won’t cure your condition. At this time, there’s no known cure for multiple sclerosis (MS).

However, Vumerity may help you have fewer relapses (when your condition gets worse) and slow the progression (worsening) of your MS. Vumerity may help you stay physically active and could delay or help prevent certain disabilities.

Vumerity may slow the development of brain lesions. Lesions can be seen on an MRI scan and may be a sign of worsening MS. Changes seen in MRI scans may help your doctor check if your treatment is working.

Do I need to have lab tests done while I’m taking Vumerity?

Yes, you’ll need to have certain lab tests done before and during your treatment.

Before you start Vumerity, your doctor will order a blood test. This test will check your levels of liver enzymes and white blood cells. You’ll have this blood test done again after 6 months of treatment with Vumerity. After that, you’ll have it done every 6 to 12 months of treatment.

Blood tests are needed to watch for early signs of certain side effects of Vumerity. For example, high levels of liver enzymes could be a symptom of liver damage. And a low white blood cell count could be a sign that you have a high risk for infection.

Before you start taking Vumerity, talk with your doctor about any lab tests you’ll need.

Will I have to follow a certain diet while I’m using Vumerity?

No, you don’t have to follow a certain diet while using Vumerity. However, if you choose to take your dose with food, it’s important that your meal or snack doesn’t have more than 700 calories or 30 grams (g) of fat. Taking Vumerity with food that has more calories or fat than this can block the drug from being absorbed. This may make it less effective.

If you drink alcohol, you should not drink it at the same time that you take your dose of Vumerity. Clinical studies show that alcohol may reduce how well your body absorbs Vumerity. This could make the drug less effective.

For more details, see the “Vumerity and alcohol” section above.

Can I take Vumerity if I have kidney disease?

Possibly. Whether you can take Vumerity depends on how severe your condition is. If your kidney disease is mild, you should be able to take Vumerity. However, this drug isn’t recommended for people with moderate or severe kidney disease.

If you’ve had kidney problems, talk with your doctor before starting Vumerity.

Vumerity precautions

Before taking Vumerity, talk with your doctor about your health history. Vumerity may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Currently taking dimethyl fumarate (Tecfidera). Vumerity and Tecfidera should not be taken together because the body converts these drugs into the same exact substance. After being absorbed, the body converts both Vumerity and Tecfidera into monomethyl fumarate (MMF). Too much MMF could increase the chance of side effects. If you’re currently taking Tecfidera and wish to switch to Vumerity, talk with your doctor.
• Kidney problems. If you have moderate to severe kidney disease, you should not take Vumerity. The drug has not been studied in people whose kidney disease was moderate to severe. However, you may be able to take Vumerity if you have mild kidney disease. Talk with your doctor to see if this drug is right for you.
• Liver problems. If you have increased liver enzymes or liver damage, Vumerity may not be safe for you. This is because the drug could increase your liver enzyme levels. If you already have liver problems, this medication could make your condition worse. Your doctor will check your liver function with a blood test before you start Vumerity.
• Immune system problems. If you have problems with your immune system, such as low white blood cell levels or trouble fighting infections, Vumerity may not be safe. This is because Vumerity can cause lymphocytopenia (low white blood cell levels). If you already have immune system problems, Vumerity could raise your risk for serious infection. Talk with your doctor to see if Vumerity is safe for you.
• Allergic reaction. If you’ve had an allergic reaction to dimethyl fumarate (Tecfidera), Vumerity, or any of their ingredients, you should not take Vumerity. Ask your doctor about other medications that may be better options for you.
• Pregnancy. It isn’t known if Vumerity is safe to take while pregnant. For more information, see the “Vumerity and pregnancy” section above.
• Breastfeeding. It’s not known whether Vumerity is safe to take while breastfeeding. For more information, see the “Vumerity and breastfeeding” section above.

Note: For more information about the potential negative effects of Vumerity, see the “Vumerity side effects” section above.

Vumerity 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, call 911 or your local emergency number, or go to the nearest emergency room right away. If your symptoms are mild, you can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool.