Drug Detail:Opicapone (Opicapone [ oh-pik-a-pone ])
Drug Class: Dopaminergic antiparkinsonism agents
Usual Adult Dose for Parkinson's Disease
50 mg orally once a day at bedtime
Use: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes
Renal Dose Adjustments
Mild/moderate renal impairment: No adjustment recommended
Severe renal impairment: Monitor for adverse reactions and discontinue if tolerability issues arise
End stage (CrCl less than 15 mL/min) renal impairment: Use should be avoided
Liver Dose Adjustments
Mild hepatic impairment (Child-Pugh A): No adjustment recommended
Moderate hepatic impairment (Child-Pugh B): 25 mg orally once daily at bedtime
Severe hepatic impairment (Child-Pugh C): Use should be avoided
Dose Adjustments
Dyskinesia:
- Because this drug potentiates the effects of levodopa, dose reduction of levodopa or other dopaminergic drugs may mitigate dyskinesia
Drug discontinuation:
- Upon discontinuation, monitor closely and adjust other dopaminergic therapies as needed
Precautions
CONTRAINDICATIONS:
- Concomitant use with non-selective monoamine oxidase (MAO-A and MAO-B) inhibitors
- Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take orally once a day at bedtime
- Patients should not eat food for 1 hour before and for at least 1 hour after intake
MISSED DOSE: If a dose is missed, take the next dose at the scheduled time the next day
Storage requirements:
- Store at a temperature below 30C (86F)
General:
- This drug enhances the effects of levodopa; this drug has no antiparkinsonian effect of its own and must be administered with a levodopa/DOPA decarboxylase inhibitor (DDCI).
Monitoring:
- Cardiovascular: Monitor for signs and symptoms of orthostatic hypotension, particularly during dose escalation
- Nervous System: Question patients about somnolence and drowsiness
- Psychiatric: Question patients about new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
- Patients should understand that drug therapy for Parkinson's disease often causes dizziness, and drowsiness; patients should not drive a car or operate machinery or perform other potentially dangerous activities until it is determined how adding this drug affects their mental and/or motor performance.
- Patients should be instructed to report episodes of new or worsening dyskinesia (tremors and involuntary muscle movements), and new or worsening compulsive behaviors and/or unusual urges.
- Patients should be instructed to contact their healthcare provider before stopping this drug.