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On this page, you can:

  • Get quick answers to common questions you and your patients may have about TECFIDERA
  • Find a list of websites with more information about MS for you and your patients

How is TECFIDERA thought to work?


TECFIDERA is thought to offer a different approach in relapsing MS by activating the Nrf2 pathway. The Nrf2 (nuclear factor [erythroid-derived 2]-like 2) pathway is involved in the cellular response to oxidative stress. The mechanism by which TECFIDERA exerts therapeutic effects in MS is unknown.1

How do patients take TECFIDERA?

TECFIDERA offers twice-daily oral dosing—1 pill in the morning and 1 pill at night. The starting dose (120 mg capsule) is taken twice a day for the first 7 days of treatment.  After 7 days, patients are increased to the maintenance dose (240 mg capsule) twice a day.1

  • TECFIDERA can be taken with or without food, but taking TECFIDERA with food may help with flushing1
  • TECFIDERA should be swallowed whole and intact1
  • TECFIDERA should not be crushed or chewed, and the capsule contents should not be sprinkled on food1
  • Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose1
    • Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed
    • Discontinuation of TECFIDERA should be considered for patients unable to tolerate return to the maintenance dose

Learn about the oral dosing of TECFIDERA

How effective is TECFIDERA?

In the DEFINE* trial, a 2-year, randomized, double-blind, placebo-controlled study in 1234 patients with relapsing remitting MS1:

  • TECFIDERA significantly reduced risk and frequency of relapses
  • TECFIDERA delayed the progression of disability
  • TECFIDERA significantly reduced all measures of MRI activity

In the CONFIRM trial, a 2-year, multicenter, randomized, double-blind, placebo-controlled study that also included an open-label comparator arm in 1417 patients with relapsing remitting MS1:

  • TECFIDERA significantly reduced risk and frequency of relapses
  • TECFIDERA significantly reduced all measures of MRI activity
  • The reduction in the proportion with disability progression was not statistically significant

*Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting Multiple Sclerosis.2
Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis.3
Disability progression was defined as at least a 1-point increase from EDSS of ≥1, OR at least a 1.5-point increase for patients with baseline EDSS of 0 sustained for 12 weeks.1

Learn about the efficacy of TECFIDERA

What should I know about the safety and tolerability of TECFIDERA?

  • TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of its excipients1
  • TECFIDERA carries the following warnings and precautions: anaphylaxis and angioedema, PML (Progressive multifocal leukoencephalopathy), lymphopenia, liver injury, and flushing1
  • The most common adverse reactions (incidence ≥10%, and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea1
  • For more information, please view the full Prescribing Information

See additional safety information for TECFIDERA

Are there monitoring requirements for TECFIDERA?

  • Before initiating treatment with TECFIDERA:
    • A CBC including lymphocyte count should be obtained as a baseline1
    • Obtain liver tests (serum aminotransferase, alkaline phosphatase, and total bilirubin levels)1
  • During treatment with TECFIDERA:
    • A CBC including lymphocyte count should be obtained after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated1
    • Liver tests should be obtained per clinical judgment1

Learn more about monitoring with TECFIDERA

How can patients get started on TECFIDERA?

Biogen is committed to getting your patients on therapy as soon as possible. When your patient is ready to start on TECFIDERA, you can complete a TECFIDERA Start Form and fax it to Above MS™ at 1-855-474-3067. When the TECFIDERA Start Form is received, it will be sent to a specialty pharmacy that is compatible with your patient's insurance coverage. The specialty pharmacy will work with your patient's insurance company or, if necessary, find alternative funding sources to get your patient on TECFIDERA as quickly as possible. The prescription can then be shipped directly to your patient's home.

The QuickStart Program benefits your eligible TECFIDERA patients. This program is designed to get commercially insured patients (non-Medicare/Medicaid) on therapy as soon as possible by providing a limited, no-cost supply to eligible patients who have not yet received access to TECFIDERA from their insurance provider promptly upon submission of the prescription. If necessary, a limited number of subsequent supplies of TECFIDERA are given at no cost to eligible patients to help ensure that no patient experiences a gap in treatment.

What financial assistance options are available to help patients pay for TECFIDERA?

The TECFIDERA Above MS™ program can allow your patients to focus on TECFIDERA treatment and not its cost. Above MS™ offers insurance counseling—with help sorting through benefits, including Medicare—and financial assistance programs. A $0 Copay Program is available for eligible patients.* Above MS™ can also provide TECFIDERA for free to those who are truly in need. You or your patients can learn more about Above MS™ by calling 1-800-456-2255.

*Copay details and eligibility include:
Please note that the $0 Copay Program provides a monthly supply of TECFIDERA. Patients are eligible to enroll in the $0 Copay Program for as long as they are treated with TECFIDERA.
Federal and state laws may prevent eligibility. People covered by Medicare, Medicaid, the VA/DoD, or any other federal plans are not eligible to enroll. In addition, some insurance providers may prevent eligibility or restrict eligibility to people with demonstrated financial need. If patients are not eligible or not sure of their eligibility, they can call Above MS™. There are charitable programs and even a free drug program sponsored by Biogen that may be able to help with the cost.
Depending on patients' income or, in some cases, if their medication is obtained from an out-of-network provider, there may be an annual cap that limits the amount of assistance they can receive over one year.

Learn more about TECFIDERA coverage

What tools are available to help patients learn more?

Each patient can receive a patient information kit to help them learn more about TECFIDERA, as well as a welcome kit to help them get started on TECFIDERA. Your patients also have access to support services that offer financial assistance, a 24/7 nurse educator hotline, and the latest information on local MS events. For the most information, your patients can visit our patient-friendly website—TECFIDERA.com.

TECFIDERA
If your patients ask for more information about TECFIDERA, you can direct them to our patient-friendly website.
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The links below will take you to websites that are outside the control of Biogen. We provide links as a public service and for informational purposes only. We do not make or imply any endorsement of external websites and do not control any of the content.

MS Foundation—for Healthcare Professionals
On this website, you'll find free patient materials and more.
Visit Now

National Multiple Sclerosis Society
Here, you can find information about MS that is tailored for those who are newly diagnosed and those who have had MS for years. Plus, see how you or your patients can contribute time, skills, or ideas to help make a difference in MS.
Visit Now

The Multiple Sclerosis Association of America
Get information about attending special events or other ways you can help with MS research. Plus, check out the blog for timely, interactive discussions of topics that are important to the entire MS community.
Visit Now

National Institute of Neurological Disorders and Stroke
See what MS research is currently being done.
Visit Now

Indication

Tecfidera® (dimethyl fumarate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

 

Important Safety Information

TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Patients experiencing signs and symptoms of anaphylaxis and angioedema (which have included difficulty breathing, urticaria, and swelling of the throat and tongue) should discontinue TECFIDERA and seek immediate medical care.

Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received TECFIDERA in a clinical trial. PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x109/L. The symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms.

TECFIDERA may decrease lymphocyte counts; in clinical trials there was a mean decrease of ~30% in lymphocyte counts during the first year which then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but not to baseline. Six percent of TECFIDERA patients and <1% of placebo patients had lymphocyte counts <0.5x109/L. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.

There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or ≤0.5x109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years). In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months. In these patients, the majority of lymphocyte counts remained <0.5x109/L with continued therapy. A complete blood count including lymphocyte count should be obtained before initiating treatment, 6 months after starting, every 6 to 12 months thereafter and as clinically indicated. Consider treatment interruption if lymphocyte counts <0.5x109/L persist for more than six months and follow lymphocyte counts until lymphopenia is resolved. Consider withholding treatment in patients with serious infections until resolved. Decisions about whether or not to restart TECFIDERA should be based on clinical circumstances.

Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients.

Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials.

Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.

TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). 40% of patients taking TECFIDERA reported flushing, which was mostly mild to moderate in severity. Three percent of patients discontinued TECFIDERA for flushing and <1% had serious flushing events that led to hospitalization. Taking TECFIDERA with food may reduce flushing. Alternatively, administration of non-enteric coated aspirin prior to dosing may reduce the incidence or severity of flushing.

TECFIDERA may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Four percent of TECFIDERA patients and <1% of placebo patients discontinued due to GI events. The incidence of serious GI events was 1%. The most common adverse reactions associated with TECFIDERA versus placebo are flushing (40% vs 6%) and GI events: abdominal pain (18% vs 10%), diarrhea (14% vs 11%), nausea (12% vs 9%).

A transient increase in mean eosinophil counts was seen during the first two months. TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage patients who become pregnant while taking TECFIDERA to enroll in the TECFIDERA pregnancy registry by calling 1-866-810-1462 or visiting www.TECFIDERApregnancyregistry.com.

Please see full Prescribing Information and Patient Information for additional important safety information.

 

References: 1. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 2. Gold R, Kappos L, Arnold DL, et al. N Engl J Med. 2012;367:1098-1107. Erratum in: N Engl J Med. 2012;367:2362. 3. Fox RJ, Miller DH, Phillips JT, et al. N Engl J Med. 2012;367:1087-1097. Erratum in: N Engl J Med. 2012;367:1673