Opicapone

eMC §4.2 (Ongentys hard capsules). Opicapone is given as an adjunct to levodopa treatment and enhances the effects of levodopa. DOSE ADJUSTMENT OF ANTIPARKINSONIAN THERAPY: it is often necessary to adjust the levodopa dose by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after starting opicapone, according to the clinical condition of the patient, to reduce levodopa-related dopaminergic adverse reactions (dyskinesia, hallucinations, nausea, vomiting, orthostatic hypotension). If opicapone is discontinued, the dosing of other antiparkinsonian treatments, especially levodopa, must be adjusted to maintain sufficient symptom control. MISSED DOSE: if one dose is missed, take the next dose as scheduled - do not take an extra dose to make up for it. ELDERLY: no dose adjustment needed, but caution must be exercised in patients 85 years of age and over as there is limited experience in this age group. HEPATIC IMPAIRMENT: no dose adjustment in mild impairment (Child-Pugh A); limited clinical experience in moderate impairment (Child-Pugh B) - caution must be exercised and dose adjustment may be necessary; no clinical experience in severe impairment (Child-Pugh C) - not recommended. The US label instead specifies 25 mg once daily at bedtime in moderate hepatic impairment (Child-Pugh B) and avoidance in severe (Child-Pugh C). PAEDIATRIC: there is no relevant use of opicapone in the paediatric population with Parkinson's disease and motor fluctuations (eMC §4.2); the US label states safety and effectiveness in paediatric patients have not been established. MONITORING: increases in liver enzymes have been reported with nitrocatechol COMT inhibitors - for patients with progressive anorexia, asthenia and weight decrease over a relatively short period, a general medical evaluation including liver function should be considered. Patients and carers should be told that impulse control disorders (pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating, compulsive eating) can occur with dopaminergic treatment; monitor regularly. EXCIPIENTS: contains lactose - not to be taken by patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. The US label also notes food should be avoided for 1 hour before and at least 1 hour after intake.