INDICATIONS AND USAGE

GILENYA 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 patients 10 years of age and older.

DOSAGE

Important Administration Instructions

Patients who initiate GILENYA, and those who reinitiate treatment after discontinuation for longer than 14 days, require first-dose monitoring. This monitoring is also recommended when the dose is increased in pediatric patients [see Dosage and Administration (2.4, 2.5)].

GILENYA can be taken with or without food.

Recommended Dosage

In adults and pediatric patients 10 years of age and older weighing more than 40 kg, the recommended dosage of GILENYA is 0.5 mg orally once-daily.

In pediatric patients 10 years of age and older weighing less than or equal to 40 kg, the recommended dosage of GILENYA is 0.25 mg orally once daily.

Fingolimod doses higher than 0.5 mg are associated with a greater incidence of adverse reactions without additional benefit.

ADVERSE REACTIONS

Bradyarrhythmia and Atrioventricular Blocks

Infections

Progressive Multifocal Leukoencephalopathy

Macular Edema

Liver Injury

Posterior Reversible Encephalopathy Syndrome

Respiratory Effects

Fetal Risk

Severe Increase in Disability After Stopping GILENYA

Tumefactive Multiple Sclerosis

Increased Blood Pressure

Malignancies

Immune System Effects Following GILENYA Discontinuation

Hypersensitivity Reactions

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/cc9e1c8c-0e2b-44e2-878b-27057f786be9/spl-doc?hl=fingolimod

fingolimodinformation