Gilenya

Before taking this medicine

Do not take fingolimod if you: • Have had a heart attack, unstable angina, stroke, transient ischemic attack (TIA or “mini-stroke”), worsening heart failure requiring hospital admission, or Class III or IV heart failure within the past 6 months. • Have or have previously had certain heart conduction disorders, Mobitz type II second-degree or third-degree AV block, or sick sinus syndrome, unless you have a functioning pacemaker. • Have a baseline QTc interval of 500 milliseconds or longer, as measured on an ECG. • Have a heart rhythm disorder requiring treatment with Class Ia or Class III anti-arrhythmic medicines. • Have had an allergic reaction to fingolimod or any of its ingredients. Reactions may include rash, hives or angioedema (swelling). Do not start treatment while you have an active infection. Fingolimod may increase infection risk. A complete blood count is needed before treatment, and monitoring for infection should continue during treatment and for 2 months after stopping. Treatment should be withheld at the first sign or symptom suggesting progressive multifocal leukoencephalopathy (PML). Fingolimod increases the risk of macular edema, a swelling in part of the retina. Diabetes or a history of uveitis increases this risk. Eye examinations are needed near the start of treatment, after 3 to 4 months, periodically during treatment and whenever vision changes. Liver tests are needed before and periodically during treatment, with close monitoring for people with severe liver impairment. Treatment should be stopped if liver injury develops without another cause. Breathing problems require assessment when clinically indicated. Blood pressure should be monitored, and skin examinations are recommended before or shortly after starting treatment and periodically thereafter. Suspicious skin lesions should be evaluated. Fingolimod may harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for 2 months after stopping. Treatment should be stopped if posterior reversible encephalopathy syndrome (PRES) is suspected. Severe worsening of disability can occur after stopping fingolimod and requires monitoring. A severe MS relapse during or after treatment may require imaging to assess for tumefactive MS.