Frequently Asked Questions

What is VUMERITY used for?

VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults.1

Learn more about VUMERITY
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

Learn more about bioequivalent exposure
Is VUMERITY generic Tecfidera® (dimethyl fumarate)?
  • VUMERITY has a distinct chemical structure from that of TECFIDERA (dimethyl fumarate [DMF]) but is converted to the same active metabolite, monomethyl fumarate.1,3
  • GI tolerability for VUMERITY and DMF was evaluated head to head in the EVOLVE-MS-2 study.4
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
Learn more about dosing
How effective is VUMERITY?

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.

Explore efficacy
What should I know about the safety of VUMERITY?
  • VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, to 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
Explore safety
Does VUMERITY cause hair loss?

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.

What is the tolerability profile of VUMERITY?

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

See results on GI tolerability of VUMERITY vs dimethyl fumarate

GI=gastrointestinal; RRMS=relapsing-remitting multiple sclerosis.

Does VUMERITY suppress the immune system?

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.

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.

Learn more about monitoring with VUMERITY
Can patients drink alcohol while taking VUMERITY?

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.

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.

Learn about services to support your patients starting VUMERITY
How much does VUMERITY cost and 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 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.

Learn more about VUMERITY coverage
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 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.

Start your patients on VUMERITY
How does COVID-19 impact patient access to VUMERITY?

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.

Indication

VUMERITY® (diroximel 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

VUMERITY is contraindicated in patients

  • With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Reactions may include anaphylaxis and angioedema
  • Taking dimethyl fumarate

WARNINGS AND PRECAUTIONS

Anaphylaxis and Angioedema

  • VUMERITY can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (which has the same active metabolite as VUMERITY) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue VUMERITY and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema

Progressive Multifocal Leukoencephalopathy

  • Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (which has the same active metabolite as VUMERITY). 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 dimethyl fumarate for 4 years while enrolled in a clinical trial
  • PML has occurred in patients taking dimethyl fumarate 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 <0.8×109/L persisting for more than 6 months
  • At the first sign or symptom suggestive of PML, withhold VUMERITY 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 in patients treated with dimethyl fumarate (which has the same active metabolite as VUMERITY), 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 VUMERITY 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 dimethyl fumarate, 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 VUMERITY treatment in patients with herpes zoster or other serious infections until the infection has resolved

Lymphopenia

  • VUMERITY may decrease lymphocyte counts. In the MS placebo-controlled trials with dimethyl fumarate (which has the same active metabolite as VUMERITY), mean lymphocyte counts decreased by approximately 30% during the first year of treatment with dimethyl fumarate and then remained stable. Four weeks after stopping dimethyl fumarate, mean lymphocyte counts increased but did not return to baseline. The incidence of infections and serious infections was similar in patients treated with dimethyl fumarate 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 dimethyl fumarate, 2% of patients experienced prolonged, severe lymphopenia (defined as lymphocyte counts <0.5 x 109/L for at least six months); in this group of patients, the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy. In these patients with prolonged, severe lymphopenia, the median time for lymphocyte counts to return to normal after discontinuing dimethyl fumarate was 96.0 weeks
  • In these controlled and uncontrolled clinical studies, among patients who did not experience prolonged, severe lymphopenia during treatment, the median times for lymphocyte counts to return to normal after discontinuing dimethyl fumarate were as follows:
    • 4.3 weeks in patients with mild lymphopenia (lymphocyte count ≥0.8 x 109/L) at discontinuation,
    • 10.0 weeks in patients with moderate lymphopenia (lymphocyte count 0.5 to <0.8 x 109/L) at discontinuation, and
    • 16.7 weeks in patients with severe lymphopenia (lymphocyte count <0.5 x 109/L) at discontinuation.
  • Neither VUMERITY nor dimethyl fumarate have been studied in patients with preexisting low lymphocyte counts
  • Obtain a complete blood count (CBC), including lymphocyte count, before initiating treatment with VUMERITY, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of VUMERITY 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 VUMERITY is discontinued or interrupted because of 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 dimethyl fumarate (which has the same active metabolite as VUMERITY) in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with dimethyl fumarate. 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 with dimethyl fumarate
  • Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with VUMERITY and during treatment as clinically indicated. Discontinue VUMERITY if clinically significant liver injury induced by VUMERITY is suspected

Flushing

  • VUMERITY may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials of dimethyl fumarate (which has the same active metabolite as VUMERITY), 40% of dimethyl fumarate-treated patients experienced flushing. Flushing symptoms generally began soon after initiating dimethyl fumarate and usually improved or resolved over time. In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued dimethyl fumarate for flushing and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization

Serious Gastrointestinal Reactions

  • Serious gastrointestinal (GI) reactions, including perforation, ulceration, hemorrhage, and obstruction, some with fatal outcomes, have been reported in the postmarketing setting with the use of fumaric acid esters, including VUMERITY, with or without concomitant aspirin use. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation. In controlled clinical trials, the incidence of serious gastrointestinal adverse reactions was 1% in patients treated with dimethyl fumarate; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%)
  • Monitor patients, promptly evaluate, and discontinue VUMERITY for new or worsening severe gastrointestinal signs and symptoms

ADVERSE REACTIONS

  • The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate (which has the same active metabolite as VUMERITY) were flushing, abdominal pain, diarrhea, and nausea
  • Gastrointestinal adverse reactions: Dimethyl fumarate 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 dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with dimethyl fumarate
  • Hepatic transaminases: An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate 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 dimethyl fumarate or placebo
  • Eosinophilia adverse reactions: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy

USE IN SPECIFIC POPULATIONS

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VUMERITY during pregnancy. Encourage patients to enroll by calling
    1-833-569-2635 or visiting www.blossomspregnancyregistry.com

Renal Impairment

  • No dosage adjustment is necessary in patients with mild renal impairment. Because of an increase in the exposure of a major metabolite, use of VUMERITY is not recommended in patients with moderate or severe renal impairment

Please see full Prescribing Information.

References: 1. VUMERITY Prescribing Information, Biogen, Cambridge, MA. 2. Code of Federal Regulations Title 21. US Food and Drug Administration. https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.3. Accessed January 30, 2020. 3. TECFIDERA Prescribing Information, Biogen, Cambridge, MA. 4. Naismith RT, et al. CNS Drugs. 2020;34(2):185-196. 5. VUMERITY. National Multiple Sclerosis Society. https://www.nationalmssociety.org/Treating-MS/Medications/ Vumerity. Accessed April 20, 2022.

Start VUMERITY Getting Started Dosing Support Program Treatment Considerations
Bioequivalence and MOA Bioequivalent Exposure Proposed MOA
Efficacy DMF Pivotal Trial Designs Relapses Disability Brain Lesion Activity
Safety and Tolerability Well-Understood Safety Adverse Events GI Tolerability Study Managing Common Side Effects
Additional Studies GA-to-VUMERITY Switch Outcomes Persistence, Discontinuations, and Refill Adherence 13-Year Efficacy and Safety Results Real-World Data From Black and Hispanic Patients
Coverage
and Access
Sign Up FAQs Vermont Pricing Disclosure
Terms of Use Cookie Policy Privacy Policy Notice to CA Residents Contact Us Unsubscribe

© 2024 Biogen. All rights reserved.

© 2024 Biogen. All rights reserved.

All trademarks are the property of their respective owners.

For US Healthcare Professionals Only.