Frequently Asked Questions

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 flushing
  • TECFIDERA should be swallowed whole and intact
  • TECFIDERA should not be crushed or chewed, and the contents should not be sprinkled on food
  • Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose
    • 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
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How effective is TECFIDERA?

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

  • TECFIDERA reduced risk and frequency of relapses
  • TECFIDERA delayed the progression of disability
  • TECFIDERA reduced all studied 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 of 1417 patients with relapsing-remitting MS1:

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

*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
DEFINE=Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting Multiple Sclerosis2; CONFIRM=Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis3; EDSS=Expanded Disability Status Scale.

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What should I know about the safety 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), Herpes Zoster and Other Serious Opportunistic Infections, 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
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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

CBC=complete blood count.

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How can patients get started on TECFIDERA?

If you determine TECFIDERA is right for your patient, remember to specify your state's required "Dispense as Written" language in the prescriber signature of the Start Form. When the Start Form is complete, fax it to Biogen Support Services at 1-855-474-3067. 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 patients on TECFIDERA as quickly as possible. The prescription can then be shipped directly to your patient's home.

 

Remind your patients that Biogen Case Managers are available to assist with any questions or concerns. Patients can call 1-800-456-2255, Monday through Friday from 8:30 AM until 8:00 PM ET.

Learn about services to support your patients starting TECFIDERA
What financial assistance options are available to help patients pay for TECFIDERA?

Biogen can provide assistance once your patients are prescribed TECFIDERA. Biogen Support Services provides financial and insurance assistance options, including the Biogen Copay Program, which may lower medication cost for eligible patients with commercial insurance.*

 

*Effective January 1, 2021, there is an annual cap on the amount of assistance that patients can receive over a one year period. Federal and state laws and other factors may prevent or otherwise restrict eligibility. People covered by Medicare, Medicaid, the VA/DoD, or any other federal plans are not eligible to enroll. You are eligible to enroll in the Biogen Copay Program for as long as it is offered and you are treated with a Biogen relapsing MS medication. The Biogen Copay Program is no longer available for TECFIDERA patients in the states of Massachusetts and California.

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What tools are available to help patients learn more?

Your patients have full access to Biogen Support Services, including Biogen Case Managers and Nurse Educators. Biogen Case Managers will reach out to your patients after they are prescribed TECFIDERA and help educate them on financial assistance options. Nurse Educators are available to help your patients understand what to expect during treatment and provide additional resources.

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INDICATION

TECFIDERA® (dimethyl fumarate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Important Safety Information

CONTRAINDICATIONS

TECFIDERA® (dimethyl fumarate) is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS

Anaphylaxis and Angioedema

  • TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue TECFIDERA and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema

Progressive Multifocal Leukoencephalopathy (PML)

  • 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 for 4 years while enrolled in a clinical trial
  • PML has occurred in the postmarketing setting in the presence of lymphopenia (<0.9 x 109/L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8 x 109/L persisting for more than 6 months
  • At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. Typical 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
  • Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present

Herpes Zoster and Other Serious Opportunistic Infections

  • Serious cases of herpes zoster have occurred with TECFIDERA, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on TECFIDERA for signs and symptoms of herpes zoster. If herpes zoster occurs, appropriate treatment for herpes zoster should be administered
  • Other serious opportunistic infections have occurred with TECFIDERA, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment
  • Consider withholding TECFIDERA treatment in patients with herpes zoster or other serious infections until the infection has resolved

Lymphopenia

  • TECFIDERA may decrease lymphocyte counts. In the MS placebo-controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. The incidence of infections and serious infections was similar in patients treated with TECFIDERA or placebo. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8 x 109/L or ≤0.5 x 109/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5 x 109/L for 3.5 years)
  • In controlled and uncontrolled clinical trials with TECFIDERA, 2% of patients experienced lymphocyte counts <0.5 x 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy. TECFIDERA has not been studied in patients with preexisting low lymphocyte counts
  • Obtain a CBC, including lymphocyte count, before initiating treatment with TECFIDERA, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of TECFIDERA in patients with lymphocyte counts less than 0.5 x 109/L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if TECFIDERA is discontinued or interrupted due to lymphopenia. Consider withholding treatment from patients with serious infections until resolution

Liver Injury

  • 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

Flushing

  • TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). Forty percent 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 (up to 325mg) 30 minutes prior to dosing may reduce the incidence or severity of flushing

ADVERSE REACTIONS

  • The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea
  • Gastrointestinal adverse reactions: TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with TECFIDERA compared with placebo. Four percent (4%) of patients treated with TECFIDERA and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with TECFIDERA
  • Hepatic transaminases: An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the first six months of treatment, and most patients with elevations had levels < 3 times the upper limit of normal (ULN) during controlled trials. There were no elevations in transaminases ≥ 3 times the ULN with concomitant elevations in total bilirubin > 2 times the ULN. Discontinuations due to elevated hepatic transaminases were < 1% and were similar in patients treated with TECFIDERA or placebo
  • Eosinophilia adverse reactions: A transient increase in mean eosinophil counts was seen during the first two months

PREGNANCY

  • The TECFIDERA pregnancy registry study is now closed

Please see full Prescribing Information.

References: 1. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 2. Gold R, et al. N Engl J Med. 2012;367(12):1098-1107. Erratum in: N Engl J Med. 2012;367(24):2362. 3. Fox RJ, et al. N Engl J Med. 2012;367(12):1087-1097. Erratum in: N Engl J Med. 2012;367(17):1673.

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