Opicapone

Opicapone may interfere with the metabolism of medicinal products containing a catechol group that are metabolised by COMT, e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamine, leading to potentiated effects of these medicinal products. Careful monitoring of patients being treated with these medicinal products is advised when opicapone is used.

There is limited experience with opicapone when used concomitantly with tricyclic antidepressants and noradrenaline re-uptake inhibitors (e.g. venlafaxine, maprotiline and desipramine). Thus, their concomitant use should be considered with appropriate caution.

There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B). Caution must be exercised in these patients and dose adjustment may be necessary.

There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Ongentys is not recommended in these patients.

A study conducted in healthy volunteers showed that when a single dose of 50 mg opicapone was coadministered (within 1 hour) with a single dose of quinidine (600 mg), systemic exposure of opicapone decreased by 37% (AUC_0-tlast). Thus, particular consideration should be given to cases where quinidine needs to be administered together with opicapone as their co-administration should be avoided.

There are no or limited amount of data from the use of opicapone in pregnant women. Opicapone crossed the placenta in rats. Animal studies are insufficient with respect to reproductive toxicity. Opicapone is not recommended during pregnancy and in women of childbearing potential not using contraception.

Opicapone levels in the milk of lactating rats were equivalent to those in plasma. It is unknown whether opicapone or its metabolites are excreted into human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with opicapone.

Fertility

The effects of opicapone on fertility in humans have not been studied. Animal studies with opicapone do not indicate harmful effects with respect to fertility.

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.

Summary of the safety profile

The most common adverse reactions reported were nervous system disorders. Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).

Tabulated list of adverse reactions

In the table below all adverse reactions are presented by System Organ Class and frequency. Frequency categories are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies: