AUTOIMMUNE DISEASES
NESCLER®
Capsules
Pharmacotherapy
group:
Immunosuppressive agent – multiple sclerosis treatment
INN:
Fingolimod
Dosage:
fingolimod hydrochloride 0.56 mg (based on fingolimod 0.50 mg)
Available on a doctor's prescription
What is the drug NESCLER®
Fingolimod modulates
sphingosine-1-phosphate receptors (S1P receptors). Fingolimod is metabolized by
sphingosine kinase to the active metabolite fingolimod phosphate. In nanomolar
concentrations, fingolimod phosphate binds to SP1 receptors on the surface of
lymphocytes, quickly penetrates the central nervous system (CNS) through the
blood-brain barrier and binds to S1P receptors on the surface of neurons. By
binding to the SP1 receptors of lymphocytes, fingolimod phosphate blocks the
ability of lymphocytes to leave the lymph nodes, which leads to a
redistribution of lymphocytes in the body, while there is no decrease in the
total number of lymphocytes. The redistribution of lymphocytes leads to a
decrease in lymphocytic infiltration of the central nervous system, including
by inflammatory Th17 cells, a decrease in the severity of inflammation and the
degree of damage to the nervous tissue.
Packaging
7 and 28 capsules in a plastic bottle.
Indications for use
The drug is
used to treat relapsing-remitting multiple sclerosis (RRMS) in adults and children over 10 years of age to reduce
the frequency of clinical exacerbations of the disease and reduce the risk of
disability progression.
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.