Mayzent

Before taking this medicine

Do not take Mayzent if you: • Have the CYP2C9*3/*3 genotype. • Have had a heart attack, unstable angina, stroke, transient ischaemic attack (TIA), worsening heart failure requiring hospitalisation, or Class III or IV heart failure within the past 6 months. • Have Mobitz type II second-degree or third-degree atrioventricular (AV) block, or sick sinus syndrome, unless you have a functioning pacemaker. • Are allergic to siponimod or any other ingredient in Mayzent. Allergic reactions have included angioedema (swelling). Do not start Mayzent while you have an active infection. It may increase the risk of infections. A complete blood count is needed before treatment, and you should be monitored for infection during treatment. Mayzent must be withheld at the first sign or symptom of progressive multifocal leukoencephalopathy (PML). Mayzent requires caution if you have diabetes or uveitis, which increase the risk of macular oedema (swelling in part of the retina). Eye examinations are needed near the start of treatment, periodically during treatment and whenever vision changes. Mayzent may temporarily slow the heart rate. Tell your prescriber if you take beta-blockers or other medicines that lower heart rate; some combinations require cardiologist advice. It may also reduce lung function, and lung testing may be needed. Liver enzyme tests are needed before treatment. Severe liver impairment requires close monitoring, and treatment must be stopped if significant liver injury occurs. Skin examinations are recommended before or shortly after starting treatment and periodically afterwards because of the risk of skin cancers. Suspicious skin changes should be assessed. Blood pressure should also be monitored. Mayzent may harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for 10 days after stopping.