Frequently Asked Questions

What is bioequivalence?

According to the US Food and Drug Administration, bioequivalence is the absence of a significant difference in the rate and extent to which the active ingredient in pharmaceutical alternatives becomes available at the site of drug action when administered at the same dose under similar conditions.

VUMERITY and dimethyl fumarate have distinctly different chemical structures. They both are converted to the same active metabolite, monomethyl fumarate (MMF). VUMERITY and dimethyl fumarate generate bioequivalent exposure of MMF.1,2

How do patients take VUMERITY?

VUMERITY offers twice-daily oral dosing. The starting dose, one capsule (231 mg), is taken twice a day for the first 7 days of treatment. After 7 days, patients are increased to maintenance dose, two capsules (462 mg), twice a day.1

  • Temporary dose reductions to 231 mg twice a day may be considered for individuals who cannot tolerate the maintenance dose. Within 4 weeks, the recommended dose of 462 mg twice a day should be resumed
  • VUMERITY should be swallowed whole and intact
  • VUMERITY should not be crushed or chewed, and the capsule contents should not be sprinkled on food
  • If taken with food, a high-fat, high-calorie meal or snack should be avoided; the meal or snack should contain no more than 700 calories and no more than 30 g fat
  • Avoid co-administration of VUMERITY with alcohol
How effective is VUMERITY?

The efficacy of VUMERITY is described in the Supported by DMF Pivotal Trials page of the site. Follow the link below to learn more.

What should I know about the safety of VUMERITY?
  • VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. VUMERITY is also contraindicated in patients taking dimethyl fumarate1
  • VUMERITY 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) for dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea1
  • VUMERITY is not recommended in patients with moderate or severe renal impairment1
  • For more information, please view the full Prescribing Information
Are there monitoring requirements for VUMERITY?
  • Before initiating treatment with VUMERITY1:
    • A CBC, including lymphocyte count, should be obtained as a baseline
    • Obtain liver tests (serum aminotransferase, alkaline phosphatase, and total bilirubin levels)
  • During treatment with VUMERITY1:
    • A CBC, including lymphocyte count, should be obtained after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated
    • Liver tests should be obtained per clinical judgment

CBC=complete blood count.

How can patients get started on VUMERITY?

Biogen is committed to getting your patients on therapy as soon as possible. When your patient is ready to start on VUMERITY, you can complete a VUMERITY Start Form and fax it to Biogen Support Services at 1-855-474-3067. When the 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 VUMERITY as quickly as possible. The prescription can then be shipped directly to your patient's home.

The QuickStart Program benefits your eligible VUMERITY patients. This program helps commercially insured patients (non-Medicare/Medicaid) get on therapy while waiting for insurance coverage. If necessary, a limited number of subsequent supplies of VUMERITY are given at no cost to eligible patients to help ensure that no patient experiences a gap in treatment.

Remind your patients that 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 PM ET.

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

Biogen Support Services offers a variety of resources to help your patients navigate insurance and connect them with a variety of financial resources, such as working with insurance companies to clarify and confirm coverage. The Biogen Copay Program, which may lower medication cost to as low as $0 for eligible patients with commercial insurance,* and a free drug program, are also available for patients.

*Depending on income or, in some cases, if medication is obtained from an out-of-network provider, there may be an annual cap that limits the amount of assistance that patients can receive over one year. 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. Patients may be eligible to enroll in the Biogen Copay Program for as long as it is offered and as long as they are treated with a Biogen relapsing MS medication.

What tools are available to help patients learn more?

Patients can receive a Patient Information Brochure to help them learn more about VUMERITY. Your patients also have access to support services that offer financial assistance, a 24/7 Biogen Nurse Educator hotline, and the latest information on local MS events. For the most information, your patients can visit our patient website at VUMERITY.com.