Zeposia

Before taking this medicine

Do not take Zeposia if you: • Have had a heart attack, unstable angina, stroke, transient ischemic attack (TIA), worsening heart failure requiring hospital care, or Class III or IV heart failure within the last 6 months. • Have certain heart rhythm or electrical conduction disorders, Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino-atrial block, unless you have a functioning pacemaker. • Have severe untreated sleep apnea. • Are taking a monoamine oxidase (MAO) inhibitor. Do not start Zeposia while you have an active infection. It may increase infection risk; a complete blood count is needed before treatment, with monitoring for infections during treatment and for 3 months after stopping. Treatment should be withheld at the first sign or symptom suggesting progressive multifocal leukoencephalopathy (PML). Zeposia may temporarily slow the heart rate. An ECG is needed before treatment, and a cardiology consultation may be needed if you have heart conduction problems or take other medicines that slow the heart rate. Use is not recommended in severe liver impairment. Liver enzymes should be checked before and periodically during treatment. Zeposia should be stopped if liver injury occurs without another cause. Zeposia may harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for 3 months after stopping. Blood pressure should be monitored during treatment. Zeposia may reduce lung function, which should be assessed when clinically needed. It also increases the risk of macular edema, with greater risk in people with diabetes or uveitis. Eye examinations are needed near the start of treatment, periodically during treatment, and whenever vision changes occur. Skin examinations are recommended before or shortly after starting treatment and periodically thereafter; suspicious skin lesions should be evaluated.