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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 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 )

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 patient has a functioning pacemaker [ see Warnings and Precautions (5.1) ] a baseline QTc interval ≥ 500 msec cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs had a hypersensitivity reaction to fingolimod or any of the excipients in Fingolimod Capsules. Observed reactions include rash, urticaria and angioedema upon treatment initiation [ see Warnings and Precautions (5.14) ]. Recent myocardial infarction, unstable angina, stroke, transient ischemic attack(TIA), decompensated heart failure with hospitalization, or Class III/IV heart failure. ( 4 ) History of Mobitz …

Infections : Fingolimod Capsules 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 Capsules 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 capsules. 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 capsules if macular edema develops. Diabetes mellitus and uveitis increase the risk. ( 5.4 ) Liver Injury : Obtain liver enzyme results before initiation and periodically during treatment. Closely monitor patients with severe hepatic impairment. Discontinue if there is evidence of liver injury without other cause. ( 5.5 , 8.6 , 12.3 ) Posterior Reversible Encephalopathy Syndrome (PRES) : If suspected, discontinue Fingolimod Capsules. ( 5.6 ) Respiratory Effects : Evaluate when clinically indicated. ( 5.7 ) Fetal Risk : May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 2 months after stopping Fingolimod …

8.1 Pregnancy Risk Summary Available observational pregnancy registry data suggest that use of Fingolimod Capsules are associated with an increased prevalenceof major birth defects in comparison to the general population. However, limitations in the number of exposed pregnant women and inthe study design preclude definitive conclusions (see Data). Data from prospective reports to the pregnancy registry are currently notsufficient to allow for an adequate assessment of the drug-associated risk for miscarriage. Based on findings from animal studies, Fingolimod Capsules may cause fetal harm when administered to a pregnant woman. In oral studies conducted in rats and rabbits, fingolimod …