Fingolimod

eMC §4.2 (Fingolimod 0.5 mg capsules). Treatment should be initiated and supervised by a physician experienced in multiple sclerosis. PAEDIATRIC (UK SPC, 10 years of age and above — weight-band, NOT a per-kg dose): body weight 40 kg or less — one 0.25 mg capsule orally once daily; body weight above 40 kg — one 0.5 mg capsule orally once daily. Paediatric patients who start on 0.25 mg capsules and subsequently reach a stable body weight above 40 kg should be switched to 0.5 mg capsules, and when switching from 0.25 mg to 0.5 mg daily it is recommended to repeat the same first-dose monitoring as for treatment initiation. Safety and efficacy in children below 10 years of age have not been established (no data available), and there are very limited data in children aged 10-12 years — verify any under-18 use against a children's formulary. REPEAT FIRST-DOSE MONITORING is also recommended when treatment is interrupted for: 1 day or more during the first 2 weeks of treatment; more than 7 days during weeks 3 and 4; or more than 2 weeks after one month of treatment. If the interruption is shorter than these, continue with the next dose as planned. ELDERLY: use with caution in patients aged 65 years and over due to insufficient safety and efficacy data. HEPATIC IMPAIRMENT: must not be used in severe hepatic impairment (Child-Pugh class C); no dose adjustment is needed in mild or moderate impairment but caution should be exercised when initiating treatment. US LABELLING — FIRST-DOSE MONITORING DETAIL (cross-check; the UK SPC cross-refers to §4.4 which was not captured in this bundle): observe all patients for bradycardia for at least 6 hours after the first dose with hourly pulse and blood pressure measurement, and obtain an ECG prior to dosing and at the end of the observation period; continue monitoring until resolution if the 6-hour heart rate is below 45 bpm in adults, below 55 bpm in patients aged 12 years and above, or below 60 bpm in children aged 10 or 11 years, if new-onset second-degree or higher AV block appears, or if the lowest post-dose heart rate is at the end of the observation period; monitor symptomatic bradycardia with continuous ECG until resolved, continuing overnight and repeating first-dose monitoring after the second dose if pharmacological intervention is required; observe overnight patients at higher risk of symptomatic bradycardia or heart block, with a prolonged QTc, or taking drugs with a known risk of torsades de pointes. The US label also requires assessments before initiation: cardiac evaluation in certain pre-existing conditions, review of a recent complete blood count, serum transaminases and total bilirubin within the previous 6 months, a baseline fundus/macula evaluation, a baseline skin examination, review of prior antineoplastic/immunosuppressive/immune-modulating therapy, and testing for varicella zoster virus antibodies with VZV vaccination of antibody-negative patients before starting. Patients who reinitiate treatment after discontinuation for longer than 14 days require first-dose monitoring (US labelling).