Tecfidera (dimethyl fumarate) is a brand-name delayed-released oral capsule prescribed for certain forms of MS and clinically isolated syndrome (CIS). Tecfidera contains the active drug dimethyl fumarate and is classified as an Nrf2 activator.

Tecfidera is FDA-approved to treat the following conditions in adults:

  • Clinically isolated syndrome (CIS). CIS is an episode of symptoms similar to those caused by multiple sclerosis (MS) that lasts at least 24 hours. People with CIS don’t necessarily have MS, but it can often be the first sign of MS.
  • Relapsing-remitting MS (RRMS). RRMS is the most common form of MS. With RRMS, you typically have periods of relapse (when symptoms get worse) and periods of remission (when you don’t have symptoms).
  • Active secondary progressive MS (SPMS). Active SPMS is considered a more advanced form of RRMS. With active SPMS, you may not have any periods of remission. Symptoms also tend to get worse over time.

Effectiveness

Tecfidera reduces the risk of MS relapse by up to 49% over 2 years. It also reduces the risk of worsening physical disability by about 38%.

For information about the effectiveness of Tecfidera, see the “Tecfidera uses” section below.

Tecfidera can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Tecfidera. This list doesn’t include all possible side effects.

For more information on the possible side effects of Tecfidera or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist. You can also see this comprehensive article for more details.

More common side effects

The more common side effects of Tecfidera include:

These side effects may decrease or go away within a few weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects can include the following:

See below for information about each serious side effect.

PML

PML is a life threatening brain infection caused by the JC virus. It usually only happens in people whose immune system is not working fully. Very rarely, PML has occurred in people with MS who were taking Tecfidera. The people who developed PML also had decreased white blood cell levels.

To help prevent PML, your doctor will do blood tests regularly during your treatment to check your white blood cell levels. If your levels get too low, your doctor may recommend that you stop taking Tecfidera.

Your doctor will also monitor you for symptoms of PML while you take the drug. Symptoms may include:

  • weakness on one side of your body
  • vision problems
  • clumsiness
  • memory problems
  • confusion

If you have these symptoms while taking Tecfidera, call your doctor right away. Your doctor will likely do tests to check whether you have PML, and they may stop your treatment with Tecfidera.

Flushing

Flushing (discoloration of your face or neck) is a common side effect of Tecfidera. It happens in up to 40% of people who take the drug. Flushing effects typically occur soon after you start taking Tecfidera and then improve or go away entirely over several weeks.

In most cases, flushing is mild to moderate in severity, and symptoms include:

  • feelings of warmth in the skin
  • skin discoloration
  • itching
  • feeling of burning

For some, symptoms of flushing can become severe and intolerable. About 3% of people who take Tecfidera stop taking the drug due to severe flushing.

Taking Tecfidera with food can help reduce flushing. Taking an aspirin 30 minutes before taking Tecfidera can also help.

Lymphopenia

Tecfidera can cause lymphopenia, a decreased level of white blood cells called lymphocytes. Lymphopenia can increase your risk of infections. Symptoms of lymphopenia can include:

Your doctor will do blood tests before and during your treatment with Tecfidera. If your lymphocyte levels become too low, your doctor may suggest that you stop taking Tecfidera for a set time or permanently.

Liver effects

Tecfidera can cause liver side effects. It may increase levels of certain liver enzymes that blood tests can measure. This increase usually happens during the first 6 months of treatment.

For most people, these increases don’t cause problems. But for a small number of people, they may become severe and indicate liver damage. Symptoms of liver damage can include:

Before and throughout your treatment with Tecfidera, your doctor will do blood tests to check your liver function. If your liver enzymes increase too much, your doctor may have you stop taking this drug.

Severe allergic reaction

Serious allergic reactions, including anaphylaxis, can occur in some people who take Tecfidera. This can occur at any time during treatment. Symptoms of an allergic reaction can include:

  • trouble breathing
  • skin rash or hives
  • swelling of your lips, tongue, throat

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

If you’ve had a serious allergic reaction to this drug in the past, you may not be able to take it again. Taking the drug again could be fatal. If you’ve reacted to this medication before, talk with your doctor before taking it again.

Rash

About 8% of people who take Tecfidera get a mild skin rash after a few days. The rash may go away with continued use. If it doesn’t go away or becomes bothersome, talk with your doctor.

If a rash appears suddenly after you take the drug, it could be an allergic reaction. If you also have trouble breathing or your lips or tongue swell, this could be a severe anaphylactic reaction. If you think you’re having a severe allergic reaction to this drug, call 911.

Hair loss

Hair loss has not occurred as a side effect in studies of Tecfidera. However, some people who take Tecfidera have had hair loss.

In one report, a person who started taking Tecfidera began to lose hair after taking the drug for 2 to 3 months. The hair loss slowed after they took the drug for 2 more months, and the hair began to grow back.

Weight gain/Weight loss

Weight gain or weight loss is not a side effect that occurred in studies of Tecfidera. However, some people who take the drug have had weight gain. Some others have had weight loss while taking Tecfidera. It’s not clear if Tecfidera is the cause of weight gain or loss.

Fatigue

People who take Tecfidera can experience fatigue. In one study, fatigue happened in 17% of people who took it. This side effect may decrease or go away with continued use of the drug.

Stomach pain

About 18% of people who take Tecfidera have stomach pain. This side effect is most common during the first month of treatment and usually decreases or goes away with continued use of the drug.

Diarrhea

About 14% of people who take Tecfidera have diarrhea. This side effect is most common during the first month of treatment and usually decreases or goes away with continued use.

Effect on sperm or male fertility

Human studies have not evaluated the effect of Tecfidera on sperm or male* fertility. In animal studies, Tecfidera did not affect fertility, but studies in animals do not always predict what will happen in humans.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

Headache

Some people who take Tecfidera have headaches. However, it’s unclear if Tecfidera is the cause. In one study, 16% of people who took Tecfidera had headaches, but headaches happened more often in people who took a placebo pill.

Itching

About 8% of people who take Tecfidera have itchy skin. This effect may go away with continued use of the drug. If it does not go away or becomes bothersome, talk with your doctor.

Depression

Some people who take Tecfidera have a depressed mood. However, it’s unclear if Tecfidera is the cause. In one study, 8% of people who took Tecfidera had feelings of depression, but this happened more often in people who took a placebo pill.

If you have symptoms of depression that become bothersome, talk with your doctor about ways to improve your mood.

Shingles

Shingles (also known as “herpes zoster”) is an infection caused by the varicella-zoster virus (VZV), which is the same virus that causes chickenpox. If you’ve had chickenpox, the virus remains in your body for the rest of your life. Later in life, the virus may reactivate. This means it can flare up and cause symptoms of a shingles infection.

Tecfidera may cause the virus to reactivate. This can result in serious shingles infections that may affect your eyes, brain, or other body parts.

Serious shingles infections were seen in Tecfidera’s clinical trials in people who had previous exposure to VZV. A person with multiple sclerosis who was taking Tecfidera after the drug became approved also reported shingles.

Cancer

In clinical studies, Tecfidera didn’t increase the risk of cancer. In fact, some researchers are investigating whether Tecfidera might help prevent or treat some cancers.

Nausea

About 12% of people who take Tecfidera have nausea. This effect may go away with continued use of the drug. If it does not go away or becomes bothersome, talk with your doctor.

Constipation

Constipation has not been reported in clinical studies of Tecfidera. However, people who take Tecfidera sometimes have constipation. It’s not clear if this is a side effect of Tecfidera.

Bloating

Bloating has not been reported in clinical studies of Tecfidera. However, people who take Tecfidera sometimes have bloating. It’s not clear if this is a side effect of Tecfidera.

Insomnia

Insomnia (trouble falling asleep or staying asleep) has not been reported in clinical studies of Tecfidera. However, people who take Tecfidera sometimes have insomnia. It’s not clear if this is a side effect of the drug.

Bruising

In clinical studies, Tecfidera did not increase the risk of bruising. However, many people who have MS say that they often have bruising. The reason for this isn’t clear. A few theories are listed below.

  • As MS progresses, maintaining balance and coordination can become more difficult. This could result in bumping into things or falling, both of which could cause bruising.
  • A person with MS who takes Tecfidera might also take aspirin to help prevent flushing. Aspirin can increase bruising.
  • People who have taken steroids may have thinner skin, which can make them bruise more easily. So people with MS who have taken steroids could experience more bruising.

If you’re concerned about bruising while taking Tecfidera, talk with your doctor. Your doctor may do blood tests to check for other causes.

Joint pain

Joint pain can occur in people who take Tecfidera. In one study, 12% of people who took Tecfidera had joint pain. Another report described three people who had moderate to severe joint or muscle pain after starting Tecfidera.

This side effect may decrease or go away with continued use of the drug. Joint pain can also improve when a person stops taking Tecfidera.

Dry mouth

Dry mouth has not been reported in clinical studies of Tecfidera. However, people who take Tecfidera sometimes have dry mouths. It’s not clear if this is a side effect of Tecfidera.

Effects on eyes

Eye-related side effects have not been reported in clinical studies of Tecfidera. However, some people who take the drug have said that they’ve had symptoms such as:

It’s unclear if these eye effects are caused by the drug or something else. If you have these effects and they don’t go away, or they bother you, talk with your doctor.

Flu-like symptoms

The flu or flu-like symptoms have occurred in studies of people taking Tecfidera. In one such study, 6% of people who took the drug had these effects, but the effects happened more often in people who took a placebo pill.

Long-term side effects

Studies evaluating the effects of Tecfidera have lasted from 2 to 6 years. In one study lasting 6 years, the most common side effects were:

If you’re taking Tecfidera and have side effects that do not go away or become severe or bothersome, talk with your doctor. They may suggest ways to lessen or eliminate the side effects, or they may suggest that you stop taking the drug.

Tecfidera is a brand-name drug that contains the active drug dimethyl fumarate. This active drug is also available as a generic medication. A generic drug is an exact copy of the active drug in a brand-name medication.

The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in using the generic form of Tecfidera, talk with your doctor. They can tell you if it comes in forms and strengths suitable for your condition.

Tecfidera is approved by the Food and Drug Administration (FDA) for treating certain forms of multiple sclerosis (MS) as well as clinically isolated syndrome (CIS).

Tecfidera for certain forms of MS and CIS

Tecfidera is FDA-approved to treat the following conditions in adults:

  • Clinically isolated syndrome (CIS). CIS is an episode of symptoms similar to those caused by MS that lasts at least 24 hours. People with CIS don’t necessarily have MS, but it can often be the first sign of MS.
  • Relapsing-remitting MS (RRMS). RRMS is the most common form of MS. With RRMS, the condition 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 form of RRMS. With active SPMS, you may not have any periods of remission. Your symptoms also tend to get worse over time.

For more information about MS, see Medical News Today’s MS hub.

Effectiveness for MS and CIS

Tecfidera reduces the risk of MS relapse by up to 49% over 2 years. It also reduces the risk of worsening physical disability by about 38%.

Tecfidera for psoriasis (off-label use)

Tecfidera is used off-label to treat plaque psoriasis. Off-label use is when a drug is approved to treat one condition but is used to treat a different condition.

To learn more about plaque psoriasis, see our psoriasis hub.

Effectiveness for plaque psoriasis

In a clinical study, about 33% of people taking Tecfidera had their plaques clear or almost completely clear after 16 weeks of treatment. About 38% of people taking the drug had a 75% improvement in an index of plaque severity and area affected.

Several medications are available to treat relapsing forms of multiple sclerosis (MS) and clinically isolated syndrome (CIS).

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

Examples of alternative drugs include:

  • interferon beta-1a (Avonex, Rebif)
  • interferon beta-1b (Betaseron)
  • glatiramer acetate (Copaxone, Glatopa)
  • IV immunoglobulin (Bivigam, Gammagard, others)
  • monoclonal antibodies such as:
    • alemtuzumab (Lemtrada)
  • fingolimod (Gilenya)
  • teriflunomide (Aubagio)

You might like to know how Tecfidera compares with the drug Vumerity. Below is an overview of the similarities and differences between the two drugs.

TecfideraVumerity
Active drugdimethyl fumaratediroximel fumarate
Formdelayed-release oral capsuledelayed-release oral capsule
Usestreatment of:
clinically isolated syndrome (CIS)
relapsing-remitting MS (RRMS)
active secondary progressive MS (SPMS)
treatment of:
• CIS
• RRMS
• active SPMS

These medications tend to cause similar side effects. However, they may also cause some different side effects. You can find details in the prescribing information for Tecfidera and Vumerity. You can also talk with your doctor or pharmacist about similarities and differences between these drugs.

You may wonder how Tecfidera compares to other medications that are prescribed for similar uses. Below are comparisons between Tecfidera and several medications.

Tecfidera vs. Aubagio

Tecfidera and Aubagio (teriflunomide) are both classified as disease-modifying therapies. They both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Aubagio are both FDA-approved to treat relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS).

Drug forms

Tecfidera comes as a delayed-release oral capsule that you take twice daily. Aubagio comes as an oral tablet that you take once daily.

Side effects and risks

Tecfidera and Aubagio have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and AubagioTecfideraAubagio
More common side effectsdiarrhea
• nausea
flushing
• stomach pain
• vomiting
• stomach upset
itchy skin
rash
headache
• hair loss
• joint pain
Serious side effectsliver damage
• severe allergy
• brain infection (PML)
• low white blood cell levels
• (lymphopenia) •
serious flushing
• severe infection
• severe skin reactions
• nerve damage
• increased blood pressure
• lung damage
boxed warnings:* serious liver damage, fetal harm

* Aubagio has boxed warnings from the FDA. These are the strongest warning that the FDA requires. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Both Tecfidera and Aubagio are effective for treating MS and CIS. The effectiveness of these drugs has not been directly compared in clinical studies. However, in one analysis, they were compared indirectly and were found to have similar benefits.

Costs

Tecfidera and Aubagio are brand-name drugs. Tecfidera also comes as the generic drug dimethyl fumarate, but a generic version of Aubagio is not currently available. Generic forms are typically less expensive than brand-name drugs.

Tecfidera generally costs a little bit more than Aubagio. However, the exact price you pay will depend on your insurance plan.

Tecfidera vs. Copaxone

Tecfidera and Copaxone (glatiramer acetate) are both classified as disease-modifying therapies. They both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Copaxone are both FDA-approved to treat relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS).

Drug forms

One advantage of Tecfidera is that you take it by mouth. It comes as a delayed-release oral capsule that you take twice daily.

You must inject Copaxone. It comes as a self-injectable subcutaneous injection. You can inject yourself at home either once daily or three times per week.

Side effects and risks

Tecfidera and Copaxone have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and CopaxoneTecfideraCopaxone
More common side effects• nausea
• vomiting
• rash
• itchy skin
• flushing
• stomach pain
• stomach upset
• diarrhea
palpitations
fast heartbeat
• vision problems
• trouble swallowing
• injection site pain, skin discoloration, and itching
• weakness
fever
chills
fluid retention
• respiratory infections
back pain
anxiety
shortness of breath
Serious side effects(few similar serious side effects)• brain infection (PML)
• low white blood cell levels (lymphopenia)
• serious flushing
• liver damage
• severe allergy
• severe injection reaction
chest pain

Effectiveness

Both Tecfidera and Copaxone are effective for treating MS and CIS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, according to one analysis, Tecfidera may be more effective than Copaxone for preventing relapse and slowing the worsening of disability.

Costs

Tecfidera and Copaxone are brand-name drugs that are also available in generic forms. Tecfidera comes as the generic drug dimethyl fumarate, and Copaxone comes as glatiramer acetate.

Generic forms are typically less expensive than brand-name drugs. The actual amount you pay will depend on your insurance plan.

Tecfidera vs. Ocrevus

Tecfidera and Ocrevus (ocrelizumab) are both classified as disease-modifying therapies. Both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Ocrevus are both FDA-approved to treat relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS). Ocrevus is also used to treat primary progressive MS (PPMS).

Drug forms

An advantage of Tecfidera is that you can take it by mouth. It comes as a delayed-release oral capsule that you take twice daily.

Ocrevus must be injected using an intravenous (IV) infusion. A healthcare professional will administer it in a clinic or hospital. After the first two doses, you will receive an Ocrevus infusion every 6 months.

Side effects and risks

Tecfidera and Ocrevus have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and OcrevusTecfideraOcrevus
More common side effects• diarrhea• flushing
• stomach pain
• nausea
• vomiting
• stomach upset
• itchy skin
• rash
depression
respiratory infections
• back pain
herpes infections (if exposed to the virus)
• pain in arms and legs
• cough
• swelling in legs
• skin infection
Serious side effects• brain infection (PML)• low white blood cell levels (lymphopenia)
• serious flushing
• liver damage
• severe allergy
• severe infusion reaction
cancer
• severe infections
hepatitis B reactivation

Effectiveness

Tecfidera and Ocrevus are both effective for treating MS and CIS, but it’s unclear if one works better than the other. The effectiveness of these drugs has not been directly compared in clinical studies.

Costs

Tecfidera and Ocrevus are brand-name medications. Tecfidera also comes as the generic drug dimethyl fumarate. However, Ocrevus is not available in a generic form.

Generics tend to be less expensive than brand-name drugs. The actual amount you pay will depend on your insurance plan.

Tecfidera vs. Tysabri

Tecfidera and Tysabri (natalizumab) are both classified as disease-modifying therapies. Both drugs decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Tysabri are both FDA-approved to treat relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS). Tysabri is also approved for treating Crohn’s disease.

Drug forms

One advantage of Tecfidera is that you take it by mouth. Tecfidera comes as a delayed-release oral capsule that you take twice daily.

Tysabri must be administered as an intravenous (IV) infusion that you will receive in a clinic or hospital. A healthcare professional will administer the infusion once every month.

Side effects and risks

Tecfidera and Tysabri have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and TysabriTecfideraTysabri
More common side effects• rash
• itchy skin
• diarrhea
• stomach upset
• flushing
• stomach pain
• nausea
• vomiting
• headache
• fatigue
• joint pain
• weight loss or gain
urinary tract infection
• vaginal infection
• respiratory infection
flu-like symptoms
• stomach infection
• depression
• pain in arms and legs
vertigo
• irregular menstruation
constipation
Serious side effects• brain infection (PML)*
• liver damage
• severe allergy
• low white blood cell levels (lymphopenia)
• serious flushing
• life threatening herpes infection (if exposed to the virus)
• serious infections

* Both of these drugs have been linked with progressive multifocal leukoencephalopathy (PML), but only Tysabri has a related boxed warning from the FDA. This is the strongest warning the FDA requires. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Both Tecfidera and Tysabri are effective for treating MS and CIS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, according to one analysis, Tysabri may be more effective than Tecfidera in preventing relapse.

It’s important to note that due to its risk of PML, Tysabri is usually not a first-choice medication for MS.

Costs

Tecfidera and Tysabri are brand-name drugs. Tecfidera also comes as the generic drug dimethyl fumarate. However, Tysabri is not available in a generic version.

Generics typically cost less than brand-name medications. The actual amount you pay will depend on your insurance plan.

Tecfidera vs. Gilenya

Tecfidera and Gilenya (fingolimod) are both classified as disease-modifying therapies. Both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Gilenya are both FDA-approved to treat relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS) in adults. Gilenya is also approved for use in certain children.

Drug forms

Tecfidera comes as a delayed-release oral capsule that you take twice daily. Gilenya comes as an oral capsule that you take once daily.

Side effects and risks

Tecfidera and Gilenya have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and GilenyaTecfideraGilenya
More common side effects• diarrhea
• nausea
• stomach pain
• stomach upset
• flushing
• vomiting
• itchy skin
• rash
• respiratory infections
• such as flu or bronchitis
shingles
• headache
• weakness
• pain in the back or arms and legs
• hair loss
• cough
• vision problems
Serious side effects• brain infection (PML)
• liver damage
• severe allergy
• low white blood cell levels (lymphopenia)
• serious flushing• abnormal heartbeat or slow heart rate
• severe herpes infection (if exposed to the virus)
• serious infections
• reduced lung function
• fluid in the eye (macular edema)
• brain disorder (posterior reversible encephalopathy syndrome)
• increased blood pressure
skin cancer
lymphoma
seizures

Effectiveness

Both Tecfidera and Gilenya are effective for treating MS and CIS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, according to one analysis, Tecfidera and Gilenya work equally well in preventing relapse.

Costs

Tecfidera and Gilenya are brand-name drugs. Tecfidera also comes as the generic drug dimethyl fumarate. Gilenya is available as the generic fingolimod in a certain strength.

Generics typically cost less than brand-name medications. The actual amount you pay will depend on your insurance plan.

Tecfidera vs. interferon (Avonex, Rebif)

Tecfidera and interferon (Avonex, Rebif) are classified as disease-modifying therapies. Both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and interferon (Avonex, Rebif) are each FDA-approved to treat relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS) in adults.

Drug forms

One advantage of Tecfidera is that you take it by mouth. Tecfidera comes as a delayed-release oral capsule that you take twice daily.

Avonex and Rebif are two different brand names for interferon beta-1a. Both forms require administration by injection. Rebif comes as a subcutaneous injection that you inject under the skin three times per week. Avonex comes as an intramuscular injection that you inject into a muscle once weekly. You can self-administer these injections at home.

Side effects and risks

Tecfidera and interferon have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and interferonTecfideraInterferon
More common side effects• rash
• nausea
• stomach pain
• flushing
• vomiting
• stomach upset
• itchy skin
• diarrhea
• injection site pain or irritation
• flu-like symptoms
• respiratory infections
• headache
• fatigue
• weakness
• fever
• chest pain
• sleepiness
thyroid disorder
• pain in the back, joints, or muscles
• vision problems
• dizziness
• hair loss
• urinary tract infections
Serious side effects• liver damage
• severe allergy
• serious flushing
• brain infection (PML)
• low white blood cell levels (lymphopenia)
• depression
suicidal thoughts
blood disorders
• seizures
heart failure

Effectiveness

Both Tecfidera and interferon are effective for treating MS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, according to one analysis, Tecfidera may be more effective than interferon for preventing relapse and slowing the worsening of disability.

Costs

Tecfidera and interferon (Rebif, Avonex) are available as brand-name drugs. Tecfidera also comes as the generic drug dimethyl fumarate. However, interferon is not available as a generic.

Generics typically cost less than brand-name medications. The actual amount you pay will depend on your insurance.

Tecfidera vs. Protandim

Tecfidera is an FDA-approved drug for treating certain forms of multiple sclerosis (MS) and clinically isolated syndrome (CIS). Several clinical studies have shown that it can prevent MS relapse and slow the worsening of physical disability.

Protandim is a dietary supplement that contains several ingredients, including:

Some claim that Protandim works in a similar way to Tecfidera. Protandim is sometimes called a “natural Tecfidera.”

However, the Food and Drug Administration (FDA) has not approved Protandim to treat MS. Additionally, there are no studies of this drug in people with MS. Therefore, there is no reliable clinical research that it works.

Note: If your doctor has prescribed Tecfidera for you, do not replace it with Protandim. If you would like to explore other treatment options, talk with your doctor.

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 suit your needs.

Further details about Tecfidera’s dosage can be found in this article.

Dosage for multiple sclerosis (MS) and clinically isolated syndrome (CIS)

When you start taking Tecfidera, the dosage is 120 mg twice a day for the first 7 days. After this first week, the dosage is increased to 240 mg twice daily. This is the long-term maintenance dose.

For people who have bothersome side effects from Tecfidera, your doctor can temporarily reduce the maintenance dosage to 120 mg twice daily. You should restart the higher maintenance dosage of 240 mg twice daily within 4 weeks.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, just take that one dose. Don’t try to catch up by taking two doses at once.

Will I need to use this drug long term?

Yes, this medication is intended to be taken long term.

Take Tecfidera exactly according to your doctor’s instructions.

Timing

You will take Tecfidera oral capsules twice daily. It’s usually taken with the morning meal and the evening meal.

Taking Tecfidera with food

You should take Tecfidera with food. This can help reduce the flushing side effect. You can also reduce flushing by taking 325 mg of aspirin 30 minutes before taking Tecfidera if your doctor says this is safe for you.

Can Tecfidera be crushed?

Tecfidera should not be crushed or opened and sprinkled on food. You should swallow Tecfidera capsules whole.

Animal studies show that Tecfidera may be harmful to a fetus and may not be safe to take during pregnancy. However, animal studies do not always predict what will happen in humans.

Studies have not evaluated the effects of Tecfidera use during pregnancy.

If you’re pregnant or planning to become pregnant, talk with your doctor about whether you should take Tecfidera.

If you become pregnant while taking Tecfidera, you can take part in the Tecfidera Pregnancy Registry. A pregnancy registry helps gather information on how certain drugs can affect pregnancy. If you’d like to join the registry, ask your doctor, call 866-810-1462, or visit the registry’s website.

There have not been enough studies to show whether Tecfidera appears in breast milk.

If you’re taking Tecfidera and would like to breastfeed, talk with your doctor about the potential risks and benefits.

Multiple sclerosis (MS) and clinically isolated syndrome (CIS) are autoimmune diseases. With this type of condition, the immune system, which fights disease, mistakes healthy cells for enemy invaders and attacks them. This can cause chronic inflammation.

With MS, this chronic inflammation is thought to cause nerve damage, including the demyelination that causes many MS symptoms. Oxidative stress (OS) is also thought to cause this damage. OS is an imbalance of certain molecules in your body.

Tecfidera is thought to help treat MS and CIS by causing the body to produce a protein called Nrf2. This protein is thought to help regain the body’s molecular balance. This effect, in turn, helps reduce the damage caused by inflammation and OS.

In addition, Tecfidera changes some of the body’s immune cell functions to decrease certain inflammatory responses. It may also prevent the body from activating certain immune cells. These effects could also help reduce MS symptoms.

How long does it take to work?

Tecfidera will begin to work in your body right away, but it can take several weeks to reach its full effect.

While it’s working, you may not notice much improvement in your symptoms. This is because it’s mainly intended to prevent relapses.

Tecfidera doesn’t interact with alcohol. However, alcohol might worsen certain side effects of Tecfidera, such as:

If you drink alcohol, avoid drinking excessive amounts while taking Tecfidera.

Tecfidera may interact with other medications. Below is a list of medications that may interact with Tecfidera. This list may not contain all drugs that may interact with Tecfidera.

Different drug interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Before taking Tecfidera, be sure to tell your doctor and pharmacist 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.

Tecfidera and ocrelizumab (Ocrevus)

Taking Tecfidera with ocrelizumab (Ocrevus) can increase the risk of immunosuppression and resulting serious infections. Immunosuppression is when the immune system is weakened.

Tecfidera and ibuprofen

There are no known interactions between ibuprofen and Tecfidera.

Tecfidera and aspirin

There are no known interactions between aspirin and Tecfidera. Aspirin is commonly used 30 minutes before taking Tecfidera to prevent flushing.

Here are answers to some frequently asked questions about Tecfidera.

Why does Tecfidera cause flushing?

It’s not exactly clear why Tecfidera causes flushing. However, it likely has to do with the dilation (widening) of blood vessels in the face where the flushing occurs.

How can you prevent flushing from Tecfidera?

You may not be able to entirely prevent flushing caused by Tecfidera, but there are two things you can do to help reduce it:

  • Take Tecfidera with a meal.
  • Take 325 mg of aspirin 30 minutes before taking Tecfidera if your doctor says this is safe for you.

If these steps don’t help and you still have bothersome flushing, talk with your doctor.

Does Tecfidera make you tired?

Some people who take Tecfidera say they feel fatigued. However, feelings of tiredness or sleepiness are not side effects that have been found in clinical studies of Tecfidera.

Is Tecfidera an immunosuppressant?

Tecfidera does affect the immune system. It reduces some immune system functions to decrease inflammatory responses. It may also reduce the activation of certain immune cells.

However, Tecfidera is not usually categorized as an immunosuppressant. It’s sometimes called an immunomodulator, which means that it affects some functions of the immune system.

Do I need to worry about sun exposure while taking Tecfidera?

Tecfidera doesn’t make your skin more sensitive to the sun as some drugs do. However, if you experience flushing from Tecfidera, sun exposure could worsen the flushing feeling.

How effective is Tecfidera?

Tecfidera has been found to reduce MS relapse by up to 49% over 2 years. It’s also been found to reduce the risk of worsening physical disability by about 38%.

Why do I have different dosing directions after the first week?

It’s common for medications to be started at a lower dosage and then increased later. This allows your body to process a lower dosage as it adjusts to the medication.

For Tecfidera, you start with a lower dosage of 120 mg twice daily during the first 7 days. After that, the dosage is increased to 240 mg twice daily, and this is the dosage you would keep taking. However, if you have too many side effects with the higher dosage, your doctor may lower your dosage for a time.

Do I need to get blood tests while I’m on Tecfidera?

Yes. Before you start taking Tecfidera, your doctor will do blood tests to check your blood cell counts and liver function. They will likely repeat the tests during your Tecfidera. For the first year of treatment, you will probably have these tests at least every 6 months.

Taking too much of this medication can increase your risk of serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor or seek guidance from America’s Poison Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Before taking Tecfidera, talk with your doctor about any medical conditions you have. Tecfidera may not be right for you if you have certain medical conditions. These conditions include:

  • Immune system suppression: If you have a suppressed immune system, Tecfidera may worsen this condition. This effect can increase your risk of serious infections.
  • Liver disease: Tecfidera can cause liver damage. If you already have liver disease, it may worsen your condition.

When the pharmacist dispenses Tecfidera, they will add an expiration date to the label on the bottle. This date is typically 1 year from the date the medication was dispensed.

The purpose of such expiration dates is to guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has passed the expiration date, ask your pharmacist how to properly dispose of it.

How long a medication remains good can depend on many factors, including how and where the medication is stored. You should store Tecfidera at room temperature in the original container and protected from light.

The following information is provided for doctors and other healthcare professionals.

Mechanism of action

The mechanism of action of Tecfidera is complex and not fully understood. It works for multiple sclerosis (MS) and clinically isolated syndrome (CIS) through anti-inflammatory and antioxidant effects. Inflammation and oxidative stress are thought to be important pathological processes in people with MS.

Tecfidera induces the nuclear 1 factor (erythroid-derived 2)-like 2 (Nrf2) antioxidant pathway, which protects against oxidative damage in the central nervous system and reduces nerve demyelination.

Tecfidera also inhibits multiple immune pathways related to toll-like receptors, which reduces inflammatory cytokine production. Tecfidera also reduces the activation of immune T cells.

Pharmacokinetics and metabolism

After oral administration of Tecfidera, it’s rapidly metabolized by esterases to its active metabolite, monomethyl fumarate (MMF). Therefore, dimethyl fumarate isn’t quantifiable in the plasma.

The time to MMF maximum concentration (Tmax) is 2–2.5 hours.

Exhalation of carbon dioxide is responsible for eliminating 60% of the drug. Renal and fecal elimination are minor routes.

The half-life of MMF is about 1 hour.

Contraindications

Tecfidera is contraindicated in people with a known hypersensitivity to dimethyl fumarate or any excipients.

Storage

You should store Tecfidera at room temperature, 59°F to 86°F (15°C to 30°C). It should be stored in the original container and protected from light.

Prescribing information

The full Tecfidera prescribing information can be found here.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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