AUTOIMMUNE DISEASES
EUMYLEO®
Enteric-soluble capsules
Pharmacotherapy
group:
Immunosuppressants; other immunosuppressants
INN:
Dimethyl fumarate
Dosages:
120 mg; 240 mg
Available on a doctor's prescription
What is the drug EUMYLEO®:
Dimethyl fumarate has an
anti-inflammatory and immunomodulatory effect.
Dimethyl fumarate and its main
metabolite, monomethylfumarate, have also been shown to significantly reduce
immune cell activity and the subsequent release of pro-inflammatory cytokines
in response to an induced inflammatory response. In patients with psoriasis,
dimethyl fumarate affects the phenotype of lymphocytes by reducing the
formation of pro-inflammatory cytokines (ТН1, Tn17), and
increasing the production of anti-inflammatory cytokines (TН2). The therapeutic activity of dimethyl fumarate was confirmed in the
modeling of inflammation and neuroinflammatory trauma. During the first year,
the use of dimethyl fumarate may be accompanied by a decrease in the total
number of lymphocytes in the blood, on average by 30% from the initial value,
followed by its stabilization.
Dosage form
Dosage 120 mg: Solid gelatin opaque capsules No. 0el with a
white body and a bluish-green lid. The contents of the capsules are 2 round,
biconvex tablets, enteric-soluble, white-coated. On a cross-section, the tablet
core is white or almost white in color.
Dosage 240 mg: Solid gelatin opaque capsules No. 0el with a bluish-green body and lid. The contents of
the capsules are 4 round, biconvex tablets, enteric-soluble, white-coated. On a
cross-section, the tablet core is white or almost white in color.
Indications for use
EUMYLEO® is indicated for the treatment of adult patients with relapsing -
remitting multiple sclerosis.
Efficacy and safety studies
In accordance with current legislation, the drug has
proven its effectiveness, safety and quality during state registration. For
registration purposes, a bioequivalence study was conducted with the original
(reference) medicinal product.