Tecfidera is a brand-name delayed-release oral capsule prescribed for certain forms of multiple sclerosis and clinically isolated syndrome. Tecfidera contains the active ingredient dimethyl fumarate.
The Food and Drug Administration (FDA) has approved Tecfidera to treat the following conditions in adults:
- Clinically isolated syndrome (CIS): CIS refers to an episode of symptoms similar to those caused by multiple sclerosis (MS) that lasts at least 24 hours. People with CIS do not 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 worsen) and periods of remission (when you do not 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 worsen over time.
Drug details
You’ll find key information about Tecfidera here:
- Drug class: Nrf2 activator
- Generic available? yes
- Prescription required? yes
- Controlled substance? no
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 does not include all possible side effects.
For more information on the possible side effects of Tecfidera or tips on how to manage a bothersome side effect, talk with your doctor or pharmacist.
More common side effects
The more common side effects of Tecfidera include:
- flushing
- indigestion
- abdominal pain
- diarrhea
- nausea
- vomiting
- itchy skin
- rash
These side effects may decrease or go away within a few weeks. If they become more severe or do not 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:
- severe flushing
- serious infections, including progressive multifocal leukoencephalopathy (PML)
- lymphopenia (decreased white blood cell levels)
- liver damage
- serious digestive system side effects, including blockage, tears or ulcers (sores), or bleeding in the digestive tract
- severe allergic reaction
Note that serious digestive system side effects were reported after Tecfidera became available for prescription.
See the next section for information about PML, lymphopenia, and allergic reaction.
Side effect details
Here are some details on a few of the side effects Tecfidera may cause.
PML
PML is a life threatening brain infection caused by the John Cunningham virus, often referred to as the JC virus. It usually only develops 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, contact your doctor right away. Your doctor will likely do tests to check whether you have PML, and they may stop your treatment with Tecfidera.
Lymphopenia
Tecfidera can cause lymphopenia, which is a decreased level of white blood cells called lymphocytes. Lymphopenia can increase your risk of infections. Symptoms of lymphopenia can include:
- fever
- enlarged lymph nodes
- painful joints
Your doctor will do blood tests before and during your treatment with Tecfidera. If your lymphocyte level becomes too low, your doctor may suggest that you stop taking Tecfidera for a period of time or permanently.
Severe allergic reaction
Serious allergic reactions, including anaphylaxis, can occur in some people who take Tecfidera. This can happen at any time during treatment. Symptoms of an allergic reaction can include:
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 had a reaction to this medication before, talk with your doctor before taking it again.
Studies evaluating the effects of Tecfidera have lasted up to 13 years. In research that looked at Tecfidera for this length of time, the most common side effects were:
- multiple sclerosis relapse
- sore throat or runny nose
- flushing
- respiratory infection
- headache
- diarrhea
- urinary tract infection
- abdominal pain
- pain in the back, arms, or legs
- increased risk of falls
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 ingredient dimethyl fumarate. This active ingredient is also available as a generic medication. A generic drug is an exact copy of the active ingredient 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 taking the generic form of Tecfidera, talk with your doctor. They can tell you whether 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 for CIS
Tecfidera is FDA approved to treat the following conditions in adults:
- CIS: CIS is an episode of symptoms similar to those caused by MS that lasts at least 24 hours. People with CIS do not 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 (worsens) and then goes into remission (a period when you do not 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
In clinical trials, Tecfidera has been shown to be safe and effective for treating MS and CIS in adults.
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 prescribed 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 Food and Drug Administration (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:
- fingolimod (Gilenya)
- teriflunomide (Aubagio)
- ocrelizumab (Ocrevus)
You might like to know how Tecfidera compares with the drug Vumerity. Here is an overview of the similarities and differences between the two drugs.
| Tecfidera | Vumerity | |
| Active ingredient | dimethyl fumarate | diroximel fumarate |
| Form | delayed-release oral capsule | delayed-release oral capsule |
| Uses | treatment 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 with other medications that are prescribed for similar uses. The following text outlines how Tecfidera compares with Aubagio and Ocrevus.
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
The Food and Drug Administration (FDA) has approved Tecfidera and Aubagio to treat relapsing-remitting multiple sclerosis (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. (“Delayed release” means the drug is released into your body slowly over time.) 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. Here are examples of these side effects.
| Both Tecfidera and Aubagio | Tecfidera | Aubagio | |
| More common side effects | • diarrhea • nausea | • flushing • abdominal pain • vomiting • indigestion • itchy skin • rash | • headache • hair loss • joint pain |
| Serious side effects | • liver damage • severe allergy | • progressive multifocal leukoencephalopathy • 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 warnings 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 trials.
Costs
Tecfidera and Aubagio are brand-name drugs. Tecfidera also comes as the generic drug dimethyl fumarate, and Aubagio also comes as the generic drug teriflunomide. Generic forms are typically less expensive than brand-name drugs.
The exact price you pay for either Tecfidera or Aubagio will depend on your insurance plan (if any), your location, and the pharmacy you use.
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 for treating RRMS, active SPMS, and CIS. Ocrevus is also used to treat primary progressive MS (PPMS).
Drug forms
Tecfidera comes as a delayed-release oral capsule that you swallow twice daily.
Ocrevus must be given by intravenous (IV) infusion. A healthcare professional will administer this drug in a clinic or hospital. After the first two doses, you’ll receive an Ocrevus infusion every 6 months.
Side effects and risks
Tecfidera and Ocrevus have some similar side effects and some that differ. Here are examples of these side effects.
| Both Tecfidera and Ocrevus | Tecfidera | Ocrevus | |
| More common side effects | • diarrhea • respiratory infections • herpes infections (if exposed to the virus) | • flushing • abdominal pain • nausea • vomiting • indigestion • itchy skin • rash | • depression • back pain • pain in arms and legs • cough • swelling in legs • skin infection |
| Serious side effects | • brain infection • severe infections | • low white blood cell levels • serious flushing • liver damage • severe allergy | • severe infusion reaction • cancer • hepatitis B reactivation |
Effectiveness
Tecfidera and Ocrevus are both effective for treating MS and CIS, but it’s unclear whether one works better than the other. The effectiveness of these drugs has not been directly compared in clinical trials.
Costs
Tecfidera and Ocrevus are brand-name medications. Tecfidera also comes as the generic drug dimethyl fumarate. 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.
The following information describes Tecfidera 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.
Drug forms and strengths
Tecfidera comes as a delayed-release oral capsule. (“Delayed release” means the drug is released into your body slowly over time.) It’s available in two strengths: 120 milligrams (mg) and 240 mg.
Dosage for multiple sclerosis (MS) and clinically isolated syndrome (CIS)
When you start taking Tecfidera, the dosage is 120 mg twice per day for the first 7 days. After this first week, your doctor will increase the dosage to 240 mg twice per day. This is the long-term maintenance dose.
If you experience bothersome side effects from Tecfidera, your doctor can temporarily reduce the maintenance dosage to 120 mg twice per day. They’ll have you restart the higher dosage of 240 mg twice per day 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 dose at the usual time. Do not 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’ll take Tecfidera oral capsules twice per day, usually with the morning meal and the evening meal.
Taking Tecfidera with food
You should take Tecfidera with food. This can help reduce flushing, which is a side effect of the drug. You can also help reduce flushing by taking 325 mg of aspirin 30 minutes before taking Tecfidera. Before trying this remedy, ask your doctor whether it’s safe for you to take aspirin during Tecfidera treatment.
Can Tecfidera be crushed?
Tecfidera should not be crushed or opened and sprinkled on food. You should swallow Tecfidera capsules whole.
If you can become pregnant or are breastfeeding, it’s important to consider whether Tecfidera is a safe choice for you.
Animal studies suggest that Tecfidera may not be safe to take during pregnancy.
And there have not been enough studies to show whether Tecfidera appears in breast milk.
For more information, refer to this Tecfidera reproductive health article. If you have additional questions, talk with your doctor.
Multiple sclerosis (MS) and clinically isolated syndrome (CIS) are autoimmune diseases. With autoimmune diseases, the immune system mistakes healthy cells for enemy invaders and attacks them. This can cause chronic (long-term) inflammation.
With MS and CIS, chronic inflammation is thought to cause nerve damage, including the myelin damage that results in many MS symptoms. Oxidative stress (OS) is also thought to cause this damage. OS is an imbalance of certain molecules in your body.
For helping treat MS and CIS, Tecfidera’s mechanism of action is not exactly known. (“Mechanism of action” refers to how a drug works.) It may involve stabilizing and activating a protein called Nrf2. This protein may 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 Tecfidera is working, you may not notice much reduction in your symptoms. This is because the drug is mainly intended to prevent relapses.
Tecfidera does not interact with alcohol. However, alcohol might worsen certain side effects of Tecfidera, such as diarrhea, nausea, and flushing.
If you drink alcohol, talk with your doctor about how much is safe to consume while taking Tecfidera.
Tecfidera may interact with other medications. Here you’ll find an example of a medication that may interact with Tecfidera. However, it’s possible that other drugs 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 Ocrevus can increase the risk of immunosuppression (decreased immune system activity), which, in turn, increases the risk of serious infections.
Here are answers to some frequently asked questions about 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.
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 per day during the first 7 days. After that, the dosage is increased to 240 mg twice per day, and this is the dosage you’re likely to 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 taking Tecfidera?
Yes. Before you start taking Tecfidera, your doctor will order blood tests to check your blood cell counts and liver function. They will likely repeat the tests while you’re taking 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 its 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. Your doctor will monitor you for infections while you’re taking Tecfidera.
Liver disease: Tecfidera can cause liver damage. If you already have liver disease, taking Tecfidera may worsen your condition. Your doctor can recommend treatment options other than Tecfidera for multiple sclerosis (MS) or clinically isolated syndrome (CIS).
Active infection: If you have an active infection, let your doctor know. They’ll likely recommend treating the infection before you start taking Tecfidera.
Low white blood cell level: Tecfidera may decrease the level of white blood cells called lymphocytes. However, studies of the drug have not looked at the effects of the drug on people with low levels of lymphocytes.
If you have a history of a low level of lymphocytes, tell your doctor. They may suggest a treatment option other than Tecfidera for MS or CIS.
When a 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
How long a medication remains safe to use 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.
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.