Velsipity

Before taking this medicine

Do not take Velsipity if you: • Have had a heart attack, unstable angina, stroke, transient ischemic attack (TIA or “mini-stroke”), worsening heart failure requiring hospital care, or Class III or IV heart failure within the past 6 months. • Have or have previously had certain heart rhythm or electrical conduction problems, Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless you have a functioning pacemaker. Velsipity is not recommended for people with severe liver impairment. Velsipity requires caution because it may increase infection risk, temporarily slow the heart rate, delay electrical conduction in the heart, cause liver injury, raise blood pressure, cause swelling in the macula of the eye, or reduce lung function. Before treatment, checks include a complete blood count, an ECG and liver blood tests. An eye examination is needed near the start of treatment and periodically during treatment, or whenever vision changes. Blood pressure should be monitored during treatment. Skin examinations are needed before or shortly after starting treatment and periodically during treatment because of the risk of skin cancer. Suspicious skin changes should be assessed promptly. Symptoms of posterior reversible encephalopathy syndrome (PRES), a neurological condition, require medical assessment. Tell your prescriber about medicines that slow your heart rate and any current or previous medicines that suppress or alter the immune system. Their effects may overlap with Velsipity. Monitor for infection during treatment and for 5 weeks after stopping. A serious infection may require treatment to be interrupted. Avoid live attenuated vaccines during treatment and for up to 5 weeks afterwards. Velsipity may harm an unborn baby. People who can become pregnant should use effective contraception during treatment and for one week after stopping.