Ozanimod

eMC §4.2 (Zeposia hard capsules). Treatment should be initiated under the supervision of a physician experienced in the management of multiple sclerosis (MS) or ulcerative colitis (UC). The initial 7-day dose escalation regimen is REQUIRED. RE-INITIATION AFTER INTERRUPTION: repeat the same dose escalation regimen if treatment is interrupted for 1 day or more during the first 14 days of treatment; for more than 7 consecutive days between Day 15 and Day 28; or for more than 14 consecutive days after Day 28. If the interruption is shorter than these, continue with the next dose as planned. BEFORE THE FIRST DOSE (eMC §4.4): obtain an ECG in all patients to determine whether pre-existing cardiac abnormalities are present. First-dose 6-hour monitoring for signs and symptoms of symptomatic bradycardia is recommended in patients with a resting heart rate below 55 bpm, second-degree Mobitz type I AV block, or a history of myocardial infarction or heart failure - monitor hourly pulse and blood pressure with an ECG before and at the end of the 6-hour period. Extend monitoring if at hour 6 the heart rate is below 45 bpm, the heart rate is the lowest post-dose value, there is new-onset second-degree or higher AV block, or QTc is 500 msec or more; if medical treatment is required, continue monitoring overnight and repeat the 6-hour monitoring after the second dose. Cardiologist advice should be obtained before initiation in patients with a history of cardiac arrest or cerebrovascular disease (list truncated in the fetched SPC text). Caution when initiating in patients on a beta-blocker or calcium-channel blocker (e.g. diltiazem, verapamil) because of additive heart-rate lowering; these can be started in patients already on stable doses of ozanimod. Ozanimod-induced heart rate decrease can be reversed if necessary by parenteral atropine or isoprenaline. AGE: no dose adjustment is needed over 55 years, but caution is advised in MS patients over 55 and UC patients over 65 given limited data and potential increased risk of adverse reactions, especially with long-term treatment. HEPATIC IMPAIRMENT: patients with mild or moderate chronic hepatic impairment (Child-Pugh A or B) should complete the 7-day dose escalation and then take 0.92 mg once EVERY OTHER DAY; ozanimod must not be used in severe hepatic impairment (Child-Pugh C). PAEDIATRIC: safety and efficacy in children and adolescents below 18 years have not yet been established and no data are available - verify any under-18 use against a children's formulary. The US label adds pre-treatment assessments: complete blood count including lymphocyte count, transaminase and bilirubin levels, baseline fundus (including macula) evaluation, baseline skin examination, and varicella zoster virus antibody testing with vaccination of antibody-negative patients (live attenuated vaccines at least 1 month before initiation). US missed-dose advice: reinitiate with the titration regimen if a dose is missed within the first 2 weeks of treatment; after the first 2 weeks, continue treatment as planned.