![]() ![]() Eosinophilia adverse reactions: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with dimethyl fumarate or placebo PML has occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (2 times the ULN.A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial 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. ![]() Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (which has the same active metabolite as VUMERITY).Progressive Multifocal Leukoencephalopathy Patients should be instructed to discontinue VUMERITY and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema 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. VUMERITY can cause anaphylaxis and angioedema after the first dose or at any time during treatment.WARNINGS AND PRECAUTIONS Anaphylaxis and Angioedema Reactions may include anaphylaxis and angioedema With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY.Important Safety Information CONTRAINDICATIONS VUMERITY is contraindicated in patients 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. You are eligible to enroll in the Biogen Copay Program for as long as it is offered and you are treated with VUMERITY. People covered by Medicare, Medicaid, the VA/DoD, or any other federal plans are not eligible to enroll. Federal and state laws and other factors may prevent or otherwise restrict eligibility. *Effective January 1, 2021, there is an annual cap on the amount of assistance that patients can receive over a one year period. Financial assistance, including the Biogen Copay Program (which may lower medication cost for eligible patients with commercial insurance*) and a free drug program.Insurance counseling that helps the uninsured and underinsured understand government insurance programs.Communicating with insurance companies to clarify and confirm coverage, including assistance with the Prior Authorization process and denied claims.We offer a variety of resources to help your patients navigate insurance and connect them with a variety of financial resources, including: We have tools to help your patients based on their individual needs. Financial & Insurance Assistance is designed to help your patients start and continue on therapy even if cost may be a concern. ![]()
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