Tecfidera

Multiple Sclerosis

Treatment

1 FDA approval

20 Active Studies for Tecfidera

What is Tecfidera

Dimethyl fumarate

The Generic name of this drug

Treatment Summary

Dimethyl fumarate is a medication used to reduce inflammation and treat multiple sclerosis, as well as psoriasis. It works by triggering a response in the body that helps protect it from oxidative stress. The brand name for this drug is Tecfidera.

Tecfidera

is the brand name

image of different drug pills on a surface

Tecfidera Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Tecfidera

Dimethyl fumarate

2013

54

Approved as Treatment by the FDA

Dimethyl fumarate, otherwise called Tecfidera, is approved by the FDA for 1 uses like Multiple Sclerosis .

Multiple Sclerosis

Helps manage Multiple Sclerosis

Effectiveness

How Tecfidera Affects Patients

The exact way dimethyl fumarate affects the body is not known, but it is thought to reduce inflammation and protect cells. It is usually prescribed to people with multiple sclerosis (MS). Dimethyl fumarate does not usually cause heart problems, but it has been known to cause severe infections, low levels of white blood cells, liver problems, anaphylaxis, and swelling of the face or tongue.

How Tecfidera works in the body

The way dimethyl fumarate works against multiple sclerosis is not fully understood. It is believed to change how the body responds to oxidative stress, which can help reduce inflammation. Dimethyl fumarate also blocks a protein that helps cause inflammation. Additionally, monomethyl fumarate, which is a breakdown product of dimethyl fumarate, interacts with a receptor in our bodies, although it is unclear how this affects the disease. Finally, it is thought that dimethyl fumarate changes the makeup of the cells involved in the immune response, reducing the number of pro-inflammatory cells and increasing the number of anti-inflammatory

When to interrupt dosage

The advised dosage of Tecfidera is contingent upon the identified condition. The amount of dosage fluctuates, in accordance with the delivery approach (e.g. Capsule, delayed release - Oral or Oral) indicated in the table beneath.

Condition

Dosage

Administration

Multiple Sclerosis

, 120.0 mg, 240.0 mg, 360.0 mg, 30.0 mg

, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Capsule, Capsule - Oral, Tablet, delayed release - Oral, Tablet, delayed release

Warnings

There are 20 known major drug interactions with Tecfidera.

Common Tecfidera Drug Interactions

Drug Name

Risk Level

Description

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Acteoside

Major

The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with Acteoside.

Antilymphocyte immunoglobulin (horse)

Major

The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with Antilymphocyte immunoglobulin (horse).

Bacillus calmette-guerin substrain russian BCG-I live antigen

Major

The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Dimethyl fumarate.

Baricitinib

Major

The risk or severity of adverse effects can be increased when Dimethyl fumarate is combined with Baricitinib.

Tecfidera Toxicity & Overdose Risk

There have been reports of people overdosing on dimethyl fumarate. There is no known way to remove the drug from the body, so treatment focuses on dealing with the symptoms. In animal studies, mice given high doses developed tumors in their stomach and kidneys. There is no evidence that dimethyl fumarate causes mutations or chromosome damage in humans.

image of a doctor in a lab doing drug, clinical research

Tecfidera Novel Uses: Which Conditions Have a Clinical Trial Featuring Tecfidera?

Condition

Clinical Trials

Trial Phases

Multiple Sclerosis

118 Actively Recruiting

Phase 3, Not Applicable, Phase 4, Phase 2, Phase 1, Early Phase 1

Tecfidera Reviews: What are patients saying about Tecfidera?

5

Patient Review

4/14/2018

Tecfidera for Relapsing Form of Multiple Sclerosis

I was recently diagnosed with PML after taking this medication for 3 years. I had no issues until now. Has anyone else experienced this?

5

Patient Review

9/21/2016

Tecfidera for Relapsing Form of Multiple Sclerosis

I felt great while taking this medication, both mentally and physically. However, I did experience some GI side effects that eventually led me to stop taking it.

4.3

Patient Review

4/26/2016

Tecfidera for Relapsing Form of Multiple Sclerosis

After getting used to the medication (which took about 8 weeks), I started feeling better. My symptoms have improved and I'm hopeful for the future.

4

Patient Review

3/1/2017

Tecfidera for Relapsing Form of Multiple Sclerosis

Avonex was great for the first five years, but I eventually couldn't handle the side effects anymore. Tecfidera has been working really well for me so far; after almost two months, I've only experienced occasional flushing. Make sure to eat before taking it, though! Aspirin also seems to help. fingers crossed that my lab results continue looking good so I can stay on this medication. My doctor recommends an MRI six months after starting the treatment.

3.7

Patient Review

4/20/2017

Tecfidera for Relapsing Form of Multiple Sclerosis

I was diagnosed in 2010 and started taking this drug at the end of 2015. I have experienced new inflammations and relapses since then. It is easy to use, but it has not been very effective for me.

2.3

Patient Review

2/16/2016

Tecfidera for Relapsing Form of Multiple Sclerosis

Though this drug stopped the relapse, it caused severe drying of mouth, eyes, and mucous regions. Drying of eyes required drops all day, mouth caused my dentist to prescribe mouth wash and special toothpaste, bleeding from vagina area required moist wipes only. Had to discontinue use.

2.3

Patient Review

10/10/2019

Tecfidera for Relapsing Form of Multiple Sclerosis

I tried this medication for a while, but it didn't work well for me. I was on Coppaxone for years before that.

2.3

Patient Review

10/10/2019

Tecfidera for Relapsing Form of Multiple Sclerosis

I didn't have a good experience with this drug. I was on coppaxone for years

1

Patient Review

10/13/2016

Tecfidera for Relapsing Form of Multiple Sclerosis

I tried this treatment for less than a week, and it was awful. I felt like there were pins sticking me, my eyes burned, and my legs itched for an hour and a half. The needle pain from the Rebif was over in 15 seconds. I'm done with this treatment.

1

Patient Review

10/25/2016

Tecfidera for Relapsing Form of Multiple Sclerosis

I am nervous about starting Tecfidera. I had bad reactions to Rebif, and a nurse told me that this new medicine is like chemotherapy. Has anyone else had experience with this?

1

Patient Review

2/26/2019

Tecfidera for Relapsing Form of Multiple Sclerosis

I didn't get to see the full effects of this drug because I had such a terrible reaction to it. I found out later that it's actually used as a furniture preservative, and after doing more research I discovered that it can cause skin irritation and rashes. Needless to say, I was not eager to continue taking this medication!

1

Patient Review

6/7/2021

Tecfidera for Relapsing Form of Multiple Sclerosis

Unfortunately, this drug didn't help me manage my MS symptoms or the numbness and burning sensations in my extremities. I'll be discontinuing use soon and trying another medication.

1

Patient Review

3/24/2020

Tecfidera for Relapsing Form of Multiple Sclerosis

The company's customer service is unacceptable. I had to return the product just to stop the harassment.

1

Patient Review

12/13/2015

Tecfidera for Relapsing Form of Multiple Sclerosis

1

Patient Review

5/24/2016

Tecfidera for Relapsing Form of Multiple Sclerosis

My first reaction to this drug was so bad that I considered going to the emergency room. All of my MS symptoms were amplified, it was absolutely awful. Thank goodness I switched medications.

1

Patient Review

2/16/2016

Tecfidera for Relapsing Form of Multiple Sclerosis

Not only did this not help with my flare-ups, it actually made me feel worse. I would avoid this if at all possible.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about tecfidera

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Tecfidera an immunosuppressant?

"Tecfidera is a type of medicine that suppresses the immune system."

Answered by AI

What are the major side effects of Tecfidera?

"If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

The following text is about the side effects of taking a certain drug. Flushing, warmth, redness, itching, and burning feeling of the skin may occur. Taking this drug with food may reduce flushing. Stomach/abdominal pain, diarrhea, nausea, and vomiting may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly."

Answered by AI

How long can you stay on Tecfidera?

"You can take Tecfidera for as long as it is clinically beneficial to you and you can tolerate any side effects. A clinical benefit means that: your disease is not progressing significantly. you are not developing any new TD2 or Gd lesions, or existing lesions are not enlarging."

Answered by AI

What does Tecfidera do for MS?

"Tecfidera is a pill taken twice daily to help reduce the number and severity of relapses in people with relapsing remitting MS. It's been shown to reduce the number of relapses by about 50%. Common side effects include flushing and gastric upset (feeling sick, diarrhoea and stomach pains)."

Answered by AI

What are the side effects of the drug Tecfidera?

"If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

The following effects may occur when taking this drug: flushing/warmth, redness, itching, and burning feeling of the skin; taking this drug with food may reduce flushing; stomach/abdominal pain, diarrhea, nausea, and vomiting may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly."

Answered by AI

Is Tecfidera good for MS?

"Tecfidera is approved for treating relapsing forms of MS, which are the most common forms of MS. In these forms, attacks of worsening or new symptoms occur (relapse), followed by periods of partial or complete recovery (remission). Tecfidera reduces the risk of MS relapse by up to 49 percent over two years."

Answered by AI

What is the drug Tecfidera used for?

"A disease modifying therapy called dimethyl fumerate, which is sold under the brand name Tecfidera, is recommended for treating people with active relapsing multiple sclerosis. This is defined in medical guidelines as having had two or more relapses within the last two years."

Answered by AI

How long can you take Tecfidera?

"You can take Tecfidera for as long as it is clinically beneficial and you can tolerate the side effects. Clinical benefits include: little to no disease progression, no new or enlarging lesions, and tolerable side effects."

Answered by AI

Clinical Trials for Tecfidera

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Functional Balance Intervention for Multiple Sclerosis

40 - 90
All Sexes
Chicago, IL

The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.

Recruiting
Has No Placebo

University of Illinois at Chicago

Image of Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo in Buffalo, United States.

Mindset Training for MS

18 - 65
All Sexes
Buffalo, NY

People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation. Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account. In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved. This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).

Recruiting
1 Prior Treatment

Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo

Hanneke E Hulst, Prof

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Electromagnetic Resonance Therapy for Autoimmune Diseases

Any Age
All Sexes
New York, NY

The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. The goal is to see if this "quantum-synaptic" signaling effect can help stabilize immune activity and reduce the number of autoimmune flare-ups in people living with conditions such as lupus, rheumatoid arthritis, or multiple sclerosis. Participants will receive either an active or a sham (placebo) LF-EMR session three times per week for twelve weeks. Each session is completely non-invasive. Blood samples will be collected to study cytokines (immune-system messenger molecules), gene-expression patterns, and electrical field coherence among immune cells. A machine-learning system will analyze these data to predict inflammation patterns and guide individualized treatment settings. All participant data will be securely recorded and time-stamped to ensure transparency and privacy. The expected outcome of the study is a measurable reduction in autoimmune flare frequency and symptom severity, along with improved understanding of how electromagnetic signaling might safely regulate immune function.

Phase 1 & 2
Waitlist Available

Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)

Gavin Solomon, President & CEO

Truway Health, Inc.

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Ocrelizumab for Multiple Sclerosis

18 - 75
All Sexes
Detroit, MI

This study seeks to assess the effects of long-term ocrelizumab therapy on fatigue (extreme tiredness) as well as cognition (thinking and reasoning skills, such as memory, learning and attention), in veterans with multiple sclerosis. The evaluation will involve cognitive assessment scales (to assess memory, attention and learning abilities), clinical evaluations (to assess nerve function and ability to move), and patient-reported outcome measures (in which you will answer questions about your tiredness, sleep and how you function in daily life). These assessments will occur at baseline (visit 1), 6 month (Visit-2) and 12 months (visit 3) to track changes over time.

Waitlist Available
Has No Placebo

John D. Dingell VA Medical Center

Genentech, Inc.

Image of Toronto Rehabilitation Institute in Toronto, Canada.

Balance Training with Electrical Stimulation for Multiple Sclerosis

18 - 65
All Sexes
Toronto, Canada

This study will evaluate the effects of combining balance training with electrical stimulation techniques in individuals with Multiple Sclerosis (MS). MS commonly impairs leg strength, coordination, and balance, increasing the risk of falls and reducing independence. The interventions include:Balance training only, Balance training with Functional Electrical Stimulation (FES), and Balance training with FES and Transcutaneous Spinal Cord Stimulation (TSCS). FES delivers small electrical pulses to leg muscles, while TSCS delivers electrical signals through the skin to stimulate the spinal cord and enhance motor control. The study will enroll up to 24 participants over a 3-year period. This trial is funded by MS Canada. Participants will be randomly assigned to one of three groups: (1) balance training only, (2) balance training with FES, or (3) balance training with FES and TSCS. All participants will complete 12 supervised training sessions over 6 weeks. During each session, participants will engage in interactive balance games while standing in a safety harness.Outcome assessments will be conducted at three time points: baseline (prior to training), post-intervention (after 6 weeks), and follow-up (8 weeks after training). Assessments will include: * Clinical tests of mobility and balance (Timed Up and Go:TUG, 10-Meter Walk Test:10MWT, Berg Balance Scale:BBS) * Computerized balance testing using a force plate * Questionnaires on walking ability, fear of falling, and balance confidence * Neurophysiological measures of brain-spinal cord-muscle communication before and after training

Waitlist Available
Senior-friendly

Toronto Rehabilitation Institute

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Fall Prevention Program for Multiple Sclerosis

18+
All Sexes
Urbana, IL

The research team is conducting a study to determine if a fall prevention program designed specifically for people who use wheelchairs and scooters can help people better prevent and manage falls compared to the standard of care. This study will compare two groups of participants: 1. One group will use the iROLL-O+ app, which offers personalized fall prevention tools and strategies. 2. The other group will receive fall prevention information from a well-known program developed by the Centers for Disease Control and Prevention (CDC), called STEADI, which stands for Stopping Elderly Accidents, Deaths, and Injuries. This study includes adults living with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) who use a wheelchair or scooter every day. The research team aims to determine which approach is more effective in reducing falls and improving confidence in performing daily activities.

Waitlist Available
Has No Placebo

Disability Participation and Quality of Life (DPQOL) Laboratory

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[F-18]FDG-PET for MS

18 - 70
All Sexes
Boston, MA

Given the need for better diagnostic imaging techniques in multiple sclerosis (MS), the study aims to investigate the utility of \[F-18\]FDG positron emission tomography (PET) in MS. The study will be assessing glucose consumption patterns in subjects with progressive MS (PMS) and relapsing-remitting MS (RRMS), as well as healthy controls. PET will be compared to magnetic resonance imaging (MRI) lesion load and brain atrophy, and serum and blood biomarkers, as well as clinical measures of physical disability, cognitive impairment, fatigue, and depression. This study's findings may pave a path for integrating \[F-18\]FDG-PET in routine clinical practice for MS, improving patient experiences and outcomes. The specific aims of the study are: Aim 1: To compare glucose consumption in the brain in subjects with PMS, relapsing-remitting MS (RRMS), and healthy controls, using the radiolabeled glucose analogue 18-fluorodeoxyglucose, also known as \[F-18\]FDG. Aim 2: To compare the relationship between FDG-PET and standard 3T MRI measures including global and regional brain atrophy and lesion load, and to compare FDG-PET with MRI in terms of their relationship with clinical measures of physical disability, cognitive impairment, fatigue and depression in MS subjects. Aim 3: To assess the relationship of FDG-PET with serum and blood biomarkers, including but not limited to sNfL, GFAP, IL-6, and TNFα in MS.

Phase 4
Recruiting

Brigham & Women's Hospital

Tarun Singhal, MD, MBBS

Genzyme, a Sanofi Company

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