ONGENTYS

What it is

ONGENTYS contains 50 mg of opicapone as the active substance in hard capsule form. Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor with a long duration of action greater than 24 hours. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— Adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Dosing overview

The recommended dose of opicapone is 50 mg, taken once daily at bedtime, preferably without food, at least one hour before or after levodopa combinations. ONGENTYS should be taken preferably on an empty stomach, that is two hours before or two hours after a meal. It is often necessary to adjust levodopa dose by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating treatment with opicapone according to the clinical condition of the patient. No dose adjustment is necessary in patients with renal impairment. ONGENTYS is not recommended in patients with hepatic impairment or hepatic cirrhosis.

Key safety warnings

Opicapone enhances the effects of levodopa. To reduce levodopa-related dopaminergic adverse reactions such as dyskinesia, hallucinations, nausea, vomiting and orthostatic hypotension, it is often necessary to adjust the daily dose of levodopa by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating treatment with ONGENTYS. Patients and caregivers should be made aware that impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments. Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop. Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol-O-methyltransferase (COMT). For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered. Ischaemic heart diseases were frequently observed in case of use of other substances having the same mechanism of action as opicapone (COMT inhibition). Opicapone in association with levodopa may have major influence on the ability to drive and use machines. Opicapone may, together with levodopa, cause dizziness, symptomatic orthostatism and somnolence. Therefore, caution should be exercised when driving or using machines.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis. Concomitant use with monoamine oxidase (MAO-A and MAO-B) inhibitors other than those for the treatment of Parkinson's disease.

PBS listing

ONGENTYS 50 mg capsule is listed on the PBS with 2 items under a restricted restriction type, with an ex-manufacturer price of A$126.87.

Regulatory history

ONGENTYS opicapone 50 mg hard capsule was first registered on the Australian Register of Therapeutic Goods on 23 September 2020. The Pharmaceutical Benefits Scheme Advisory Committee recommended the medicine in July 2021 for Parkinson Disease.