Gilenya

Gilenya is the brand name for fingolimod, an oral disease-modifying therapy used to treat relapsing forms of multiple sclerosis. It modulates immune cell trafficking to reduce inflammatory activity in the central nervous system.

Fingolimod is a sphingosine-1-phosphate receptor modulator. By trapping lymphocytes in lymph nodes, it lowers their numbers in peripheral blood and migratory capacity, reducing autoimmune attack on myelin and decreasing relapse rate.

The drug is taken orally once daily, with a typical dose of 0.5 mg. First-dose observation is recommended for at least six hours to monitor for slow heart rate or conduction abnormalities.

Common adverse effects include headache, flu-like symptoms, back pain, and diarrhea. Serious concerns include bradycardia and AV conduction block after the first dose, increased risk of macular edema, infections due to lymphocyte reduction, and mild liver enzyme elevations.

Contraindications include significant conduction abnormalities (such as second- or third-degree AV block without a pacemaker), sick sinus syndrome, recent myocardial infarction, stroke, or decompensated heart failure. Caution is advised with QT prolongation, other bradycardia-risk drugs, active infection, liver disease, and during pregnancy.

Women who may become pregnant should use effective contraception during treatment and for at least two months after stopping fingolimod. Live vaccines are generally avoided during therapy; inactivated vaccines may be given with consideration to immune status.

Upon stopping, lymphocyte counts gradually return toward baseline over weeks to months, and patients may need monitoring when switching therapies.

Gilenya was developed by Novartis and approved for relapsing MS by regulatory agencies such as the U.S. FDA in 2010. It is available as fingolimod under the brand name Gilenya.