Vumerity
Vumerity, also known by its generic name dimethyl fumarate, is approved in adults for treating relapsing forms of multiple sclerosis (MS). It belongs to the drug class called fumaric acid derivatives. Vumerity (diroximel fumarate) is a capsule that's taken by mouth twice per day. The most common side effects are stomach upset and flushing (e.g., facial warmth, redness, burning sensation).
What is Vumerity (diroximel fumarate)?
What is Vumerity (diroximel fumarate) used for?
- Relapsing forms of multiple sclerosis (MS)
How Vumerity (diroximel fumarate) works
Vumerity (diroximel fumarate) is a type of disease-modifying therapy (DMT) called a fumaric acid derivative. More specifically, Vumerity (diroximel fumarate) is a Nrf2 activator.
It's not exactly known how Vumerity (diroximel fumarate) helps with multiple sclerosis. But the medication is thought to turn on Nrf2 pathways in the body to help protect against damage to nerve cells and lessen inflammation.
Drug facts
Side effects of Vumerity (diroximel fumarate)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Flushing (40%)
- Stomach pain (18%)
- Diarrhea (14%)
- Nausea (12%)
Less Common Side Effects
- Vomiting
- Indigestion
- Itching
- Rash
- Skin redness
- Elevated liver enzyme levels
- Low white blood cell count
Vumerity (diroximel fumarate) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: hives, rash, red skin, swelling of the lips or tongue, closing of the throat, difficulty breathing
- Severe infection: fever, difficulty breathing, diarrhea, weakness, vision problems, thinking or memory problems, personality changes
- Serious liver problems: pain on the right side of your stomach, yellowing of your skin or the whites of your eyes (jaundice), loss of appetite, dark urine
- Serious Stomach or gut issues: severe stomach pain; severe vomiting, constipation, or diarrhea; rectal bleeding; bloody diarrhea
The following Vumerity (diroximel fumarate) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
- Dizziness, loss of balance or coordination, confusion or trouble speaking
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
- Stomach pain that is severe, does not go away, or gets worse
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Vumerity (diroximel fumarate)
Pros
- Lessens the number of relapses per year
- Available in a "starter dose" bottle and "maintenance dose" bottle to help you keep track of how much medication to take
- Few interactions with other medications
Cons
- Have to take twice per day
- Flushing is a common side effect
- Shouldn't take the medication with high-fat and high-calorie meals
Pharmacist tips for Vumerity (diroximel fumarate)
- Take Vumerity (diroximel fumarate) by mouth twice per day at about the same times each day. There are some apps available for your smartphone, such as myVUMERITY, that can help remind you to take your medication on time.
- Take Vumerity (diroximel fumarate) with or without food. Taking it with food can help lessen flushing (a common side effect of the medication). But make sure that any food you eat around the time you take the medication is no more than 700 calories and no more than 30 grams of fat. High-fat, high-calorie foods can lessen how much medication gets absorbed into your body, which might make it work less well.
- Swallow the Vumerity (diroximel fumarate) capsules whole. Don't open, crush, or chew the capsules because this can affect how well the medication works. Contact your prescriber if you're having trouble swallowing the capsules.
- You can notice flushing soon after you start treatment with Vumerity (diroximel fumarate), but it should get better over time. To lessen flushing, try taking the medication with food. Also speak with your prescriber about whether it's safe for you to take uncoated aspirin (up to 325 mg) by mouth 30 minutes before each time you take Vumerity (diroximel fumarate) to help manage this side effect.
- Vumerity (diroximel fumarate) commonly causes stomach issues, such as nausea, vomiting, diarrhea, or stomach pain. If this becomes bothersome, over-the-counter options like antacids might help. Ask your care team for recommendations on what you can take. Call your care team right away if your stomach issues become severe because this can be a sign of a more serious problem.
- Don't drink alcohol at the same time as when you take Vumerity (diroximel fumarate). Alcohol can change the amount of medication that's absorbed into your body. It also raises your risk for side effects from the medication, like stomach upset and nausea. Speak with your prescriber about whether it's safe for you to drink alcohol at other times while you're taking Vumerity (diroximel fumarate).
- Mark your appointments on your calendar to keep up with scheduled tests while you're taking Vumerity (diroximel fumarate). You'll need to get blood tests periodically during treatment to check that the medication is safe for you to take. These blood tests check your liver health and your blood cell counts.
- Tell your prescriber if you become pregnant or if you're thinking of getting pregnant while you're taking Vumerity (diroximel fumarate). Discuss with them about the risks and benefits of taking the medication while pregnant. There's not enough information to know for sure how safe it is during pregnancy. So it's generally recommended to avoid taking Vumerity (diroximel fumarate) if you're pregnant unless the benefits are clearly greater than the risks.
- Ask your prescriber if you can breastfeed while you're taking Vumerity (diroximel fumarate). It's not clear how much of the medication gets into breast milk and whether it's safe for a breastfed baby. If a healthcare professional says it's okay to breastfeed while you're taking Vumerity (diroximel fumarate), look out for any side effects your baby might have, such as flushing, vomiting, and diarrhea.
Common questions about Vumerity (diroximel fumarate)
In a clinical study, about 70% of people who took Vumerity (diroximel fumarate) for 2 years were relapse-free. In addition, people taking Vumerity (diroximel fumarate) were half as likely to have a relapse as people who didn't take the medication. Talk to your prescriber or MS specialist if you have questions on how well Vumerity (diroximel fumarate) works.
Hair loss wasn't a reported side effect of Vumerity (diroximel fumarate) during clinical trials. But some people have reported hair loss after the medication got approved and became available on the market. Contact your prescriber if you notice hair loss while you're taking Vumerity (diroximel fumarate).
No, Vumerity (diroximel fumarate) doesn't cause weight gain or weight loss. Let your primary care provider know if you notice any concerning weight changes. They can help examine you and ask you questions to figure out what might be causing it.
There isn't any evidence to suggest that Vumerity (diroximel fumarate) causes cancer. There's a large study in progress that's looking at the risk of cancer and several disease-modifying therapies for multiple sclerosis, including Vumerity (diroximel fumarate). Talk to your prescriber or MS specialist if you have concerns about cancer risk and Vumerity (diroximel fumarate).
It takes about 5 hours for most of the active ingredient in Vumerity (diroximel fumarate) to leave your body after a single dose. This time frame is estimated based on the half-life of the medication. The half-life is a measure of the time it takes for the medication to leave the body. Speak with your prescriber if you're concerned about how long Vumerity (diroximel fumarate) stays in your system.
Vumerity (diroximel fumarate) and Tecfidera (dimethyl fumarate) are fumaric acid derivatives that work similarly to treat relapsing forms of multiple sclerosis (MS)
How do you switch from Tecfidera to Vumerity?
Does Vumerity (diroximel fumarate) suppress the immune system?
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Risks and warnings for Vumerity (diroximel fumarate)
Vumerity (diroximel fumarate) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe allergic reaction
- Risk factors: Allergy to dimethyl fumarate (Tecfidera)
Severe allergic reactions to Vumerity (diroximel fumarate) are possible, including life-threatening reactions like facial swelling, swelling of the tongue or throat, and anaphylaxis (closing of the throat). These allergic reactions can happen at any time during treatment. Stop taking Vumerity (diroximel fumarate) and get medical help right away if you notice hives, rash, red skin, swelling of the lips or tongue, or difficulty breathing.
Let your care team know about all of your allergies. You shouldn't use Vumerity (diroximel fumarate) if you're allergic to dimethyl fumarate (Tecfidera). These medications are similar to each other, so you might have an allergic reaction to Vumerity (diroximel fumarate) if you've had one with dimethyl fumarate (Tecfidera).
Flushing
Vumerity (diroximel fumarate) commonly causes flushing, but it should get better over time. Symptoms of flushing include warmth, redness, itching, or a burning sensation on your skin. In most cases, flushing can be bothersome but it won't cause any serious harm.
To lower the chances of flushing, you can take uncoated aspirin (up to 325 mg) half an hour before you take Vumerity (diroximel fumarate) if your prescriber tells you it's safe for you. It's also helpful to take Vumerity (diroximel fumarate) with food to lower your risk of flushing.
Risk for serious infections
- Risk factors: Taking medications that weaken your immune system | Medical conditions that raise your risk of infections
Vumerity (diroximel fumarate) can put you at higher risk for serious infections because the medication can weaken your immune system. In studies, some people developed herpes zoster (shingles). Other people had serious bacterial, fungal, or viral opportunistic infections (those that typically don't cause problems but can lead to more severe illness for people with a weakened immune system). This included rare cases of a serious opportunistic viral infection of the brain called progressive multifocal leukoencephalopathy (PML).
Make sure your prescriber knows about your medical history before you start Vumerity (diroximel fumarate). During treatment, tell your care team if you feel sick or have symptoms like fever, cough, tiredness, or muscle pain. Also call your care team right away if you notice weakness on one side of the body, clumsiness, changes in personality, or confusion. These can be early signs of PML.
If you develop a serious infection while you're taking Vumerity (diroximel fumarate), you might have to stop the medication so your immune system can fight the infection. Your care team might examine you and give you appropriate treatment for the infection.
Low white blood cell counts (lymphopenia)
Vumerity (diroximel fumarate) can lower the amount of lymphocytes (a type of white blood cell) in your body. This can put you at risk for serious infections. You'll need to get blood draws before you start treatment and then every 6 to 12 months while you're taking the medication. This helps your prescriber check that your blood cell levels aren't too low.
If your lymphocyte count gets too low during treatment, you might need to stop taking Vumerity (diroximel fumarate) until it goes back up. Keep in mind that it can take a few months for lymphocyte counts to recover after you stop the medication. Discuss with your prescriber about when you can restart Vumerity (diroximel fumarate) or whether you need to change to a different medication.
Liver damage
- Risk factors: History of liver problems | Taking medications that affect your liver
Some people who took Vumerity (diroximel fumarate) had liver damage that sometimes required hospitalization. In studies, it's happened as early as a few days after the start of treatment, and the risk appears mostly during the first several months of treatment. Typically, the liver damage goes away once you stop taking the medication.
Because of the risk for liver damage, you'll need to get lab work done to check your liver function before you start treatment and possibly while you're taking Vumerity (diroximel fumarate). You might need to stop taking the medication if your lab work shows signs of liver injury to prevent it from getting worse. Get medical help if you have symptoms of liver injury, including yellowing of the skin or whites of the eyes, stomach pain, loss of appetite, nausea, and tiredness.
Serious stomach and gut problems
Although rare, some people who took Vumerity (diroximel fumarate) had serious stomach problems. These problems included ulcers, perforation (a hole in the digestive tract), bleeding, and bowel obstruction (a blockage in the stomach or gut). Most cases happened within 6 months of starting the medication. Call your care team right away if you have any new or worsening severe stomach pain, acid reflux, vomiting, constipation, or bloating.
Vumerity (diroximel fumarate) dosage
Typical dosage for Vumerity (diroximel fumarate)
The typical starting dose is 231 mg by mouth twice daily. After a week, your prescriber will raise the dose to 462 mg twice daily.
Your prescriber might temporarily lower your dose if you're having side effects. But you should go back to the usual maintenance dose within a month after side effects get better.
Vumerity (diroximel fumarate) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Vumerity (diroximel fumarate) will not be safe for you to take.
- Allergy to dimethyl fumarate (Tecfidera) or Vumerity (diroximel fumarate)
- Currently take dimethyl fumarate (Tecfidera)
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