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 capsule 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
How effective is TECFIDERA?

In the DEFINE trial, a 2-year, randomized, double-blind, placebo-controlled study of 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 of 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

*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 Sclerosis.3

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), 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
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.

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 MSTM 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.

 

Remind your patients that Above MS Support Coordinators 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 PM ET.

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:
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 MSTM. 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.

 

What tools are available to help patients learn more?

Patients can receive a Patient Information Brochure 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 website at TECFIDERA.com.

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.