Fingolimod

1 INDICATIONS AND USAGE Fingolimod capsules are 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. Fingolimod capsules are a sphingosine 1-phosphate receptor modulator 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. ( 1 )

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Bradyarrhythmia and Atrioventricular Blocks [see Warnings and Precautions ( 5.1 )] • Infections [see Warnings and Precautions ( 5.2 )] • Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.3 )] • Macular Edema [see Warnings and Precautions ( 5.4 )] • Liver Injury [see Warnings and Precautions ( 5.5 )] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ( 5.6 )] • Respiratory Effects [see Warnings and Precautions ( 5.7 )] • Fetal Risk [see Warnings and Precautions ( 5.8 )] • Severe Increase in Disability After Stopping Fingolimod [see Warnings and Precautions ( 5.9 )] • Tumefactive Multiple Sclerosis [see Warnings and Precautions ( 5.10 )] • In...

8.1 Pregnancy Risk Summary Available observational pregnancy registry data suggest that use of fingolimod is associated with an increased prevalence of major birth defects in comparison to the general population. However, limitations in the number of exposed pregnant women and in the study design preclude definitive conclusions (see Data). Data from prospective reports to the pregnancy registry are currently not sufficient to allow for an adequate assessment of the drug- associated risk for miscarriage.

5 WARNINGS AND PRECAUTIONS • Infections: Fingolimod may increase the risk. Obtain a complete blood count (CBC) before initiating treatment. Monitor for infection during treatment and for 2 months after discontinuation. Do not start in patients with active infections. ( 5.2 ) • Progressive Multifocal Leukoencephalopathy (PML): Withhold fingolimod at the first sign or symptom suggestive of PML. ( 5.3 ) • Macular Edema: Increases the risk of macular edema. Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with fingolimod. Conduct an evaluation of the fundus, including the macula, 3 to 4 months after treatment start, periodically while on therapy and any time there is a change in vision. Consider discontinuing fingolimod if macular edema develops. 4 CONTRAINDICATIONS Fingolimod capsules are contraindicated in patients who have: • in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or Class III/IV heart failure • a history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patien...