Ozanimod

Treatment should be initiated under the supervision of a physician experienced in the management of multiple sclerosis or ulcerative colitis. Re-initiation after interruption: the same 7-day dose escalation regimen is recommended when treatment is interrupted for 1 day or more during the first 14 days of treatment, more than 7 consecutive days between Day 15 and Day 28, or more than 14 consecutive days after Day 28; for shorter interruptions, continue with the next dose as planned. Hepatic impairment: patients with mild or moderate chronic hepatic impairment (Child-Pugh class A or B) should complete the 7-day dose escalation regimen and then take 0.92 mg once every other day; patients with severe hepatic impairment (Child-Pugh class C) must not be treated. Adults over 55 years and elderly: no dose adjustment needed, but use caution in MS patients over 55 years and UC patients over 65 years given limited data and the potential for increased adverse reactions, especially with long-term treatment. Paediatric population: safety and efficacy in children and adolescents below 18 years have not yet been established, no data available. Before initiation, obtain an ECG in all patients to determine whether pre-existing cardiac abnormalities are present; first-dose 6-hour monitoring for symptomatic bradycardia is recommended in patients with resting heart rate below 55 bpm, second-degree Mobitz type I AV block, or a history of myocardial infarction or heart failure (§4.4).