![]() 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 USE IN SPECIFIC POPULATIONS Renal Impairment Eosinophilia adverse reactions: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.dimethyl fumarate, Generic, Multiple Sclerosis, Multiple Sclerosis Agents (oral). Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with dimethyl fumarate or placebo epinephrine injection, USP autoinjector 0.3mg, 0.15mg (Mylan and Teva). 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).Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Status: Abbreviated New Drug Application Drug Label Information Updated MaIf you are a consumer or patient please visit this version. Progressive Multifocal Leukoencephalopathy NDC Code (s): 0378-0396-14, 0378-0399-91 Packager: Mylan Pharmaceuticals Inc. 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 National Drug Code (NDC) 00378-0399 Drug Uses Add to Drug List Print Get help with Imprint Code FAQs.
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