Opicapone
ONGENTYS
What it isPeripheral COMT inhibitor prolonging levodopa exposure; off episodes in Parkinson disease.
Why this oneIts long action lowers pill burden versus entacapone without tolcapone's hepatotoxicity signal.
What limits itDyskinesia can worsen as levodopa exposure rises; administration must be separated from food.
FDA-approved for
- Parkinson disease with off episodes (2020)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Parkinson's disease — adjunct to levodopa/carbidopa for off episodes | Adults | 50 mg QHS | 50 mg QHS | 50 mg QHS |
Renal No adjustment for mild-moderate; avoid in end-stage renal disease
Hepatic Moderate (Child-Pugh B): 25 mg QHS; avoid in severe (Child-Pugh C)
Separate from food by ≥1 h before and after intake
Instructions
- Take once daily at bedtime
- Do not eat food for 1 hour before and at least 1 hour after the dose
- When discontinuing, monitor and consider adjusting other dopaminergic therapies
- Missed dose: take the next dose at the scheduled time the next day
Contraindications
- MAOIs
- Pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms
Cautions
- Cardiovascular effects with COMT-metabolized drugs (arrhythmia, tachycardia, BP changes)
- Falling asleep during activities of daily living / somnolence
- Hypotension/syncope
- May cause or worsen dyskinesia
- Hallucinations and psychosis
- Impulse control/compulsive disorders
- Withdrawal-emergent hyperpyrexia and confusion
Adverse reactions
- Dyskinesia
- Constipation
- Blood creatine kinase increased
- Hypotension/syncope
- Weight decreased
Pregnancy No adequate human data; fetal abnormalities in one animal species
Lactation No data on presence in human milk
NO BOXED WARNINGS
Principal riskWorsening dyskinesia; separate from food by an hour
Cost, est. cash$300–$5,000/month
Generic entry2032 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityOrthostasis, hallucinations, dyskinesia and impulse-control symptoms; abrupt withdrawal can be hazardous.
Mechanism of action: Opicapone ballicule
