The mechanism by which VUMERITY exerts its therapeutic effect in multiple sclerosis is unknown. Monomethyl fumarate (MMF), the active metabolite of VUMERITY and dimethyl fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.1
VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults.1
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
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
The efficacy of VUMERITY is described in the Relapses, Disability, and Brain Lesion Activity pages of the site. Follow the link below to learn more.
There is no confirmed causal link between VUMERITY exposure and hair loss. However, some cases of alopecia have been reported in postmarketing experience.1
See section 6.2 of Prescribing Information for postmarketing experience.
In a phase 3, randomized, head-to-head, active-controlled, 5-week study, GI tolerability outcomes were assessed in patients with RRMS taking VUMERITY vs patients taking dimethyl fumarate.4
GI=gastrointestinal; RRMS=relapsing-remitting multiple sclerosis.
Although the mechanism by which VUMERITY exerts its therapeutic effect in multiple sclerosis is unknown, VUMERITY is thought to modulate the immune response to be less inflammatory.5 Please see Important Safety Information for specific risks associated with VUMERITY.
CBC=complete blood count.
Patients may drink alcohol while taking VUMERITY, but they should avoid co-administration with alcohol.1 For other Administration Instructions, please consult section 2.3 of the VUMERITY Prescribing Information.
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.
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 communicating with insurance companies to clarify and confirm coverage. The Biogen Copay Program, which may lower medication cost for eligible patients with commercial insurance,* and a free drug program, are also available for patients.
*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. Patients are eligible to enroll in the Biogen Copay Program for as long as it is offered and they are treated with VUMERITY.
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 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.
Biogen is committed to continuing to provide support for our patients during these unprecedented times. Biogen Support Services is here to help your patients get started on treatment and provide additional support throughout their time on a Biogen therapy. For information about Biogen initiatives in response to the COVID-19 outbreak, please visit the Biogen COVID-19 Information Center.