Ongentys (Opicapone)
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Description
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Fact Table
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| Formula | C15H10Cl2N4O6 |
| License | FDA approved (NDA 212489; initial U.S. approval 2020); EMA/UK approved 2016 |
| Bioavailability | Absolute bioavailability not stated in U.S. label; moderate-fat/moderate-calorie meal decreases AUC by 31% and Cmax by 62% |
| Legal status | Prescription only (Rx-only) |
| Chemical Name | 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide |
| Elimination half-life | Mean elimination half-life ~1–2 hours |
| Dosage (Strength) | 25 mg and 50 mg oral capsules; recommended dose 50 mg once daily at bedtime, at least 1 hour before or after food |
| Pregnancy | Based on animal data, may cause fetal harm; no adequate data in pregnant women |
| Brands | Ongentys (Amneal Pharmaceuticals LLC; originally Neurocrine/BIAL) |
| Protein binding | >99% plasma protein bound |
| PubChem CID | 135565903 |
| MedlinePlus | a620059 |
| ChEBI | 134699 |
| ATC code | N04BX04 |
| DrugBank | DB11632 |
| KEGG | D10825 |
| Routes of administration | By mouth (oral capsules) |
Ongentys (opicapone) is an oral capsule used as an add-on treatment for adults with Parkinson's disease who experience off episodes, which are periods when their medication wears off and symptoms return. It works by blocking an enzyme that breaks down levodopa to help levodopa stay active longer throughout the day. It is available by prescription alongside, not as a replacement for, treatment with levodopa/carbidopa.
Directions
Take one 50 mg capsule by mouth once daily at bedtime. Do not eat food for at least 1 hour before and at least 1 hour after taking Ongentys. Swallow the capsule whole. Do not crush or chew it. For patients with moderate liver problems, the dose may be reduced to 25 mg. Ongentys should not be used in patients with severe liver problems or end-stage kidney disease.
Ingredients
The active ingredient in Ongentys is opicapone. Inactive ingredients include lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The capsule shell may contain gelatin, titanium dioxide.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Ongentys may cause patients to fall asleep without warning, even during activities like driving or eating. Avoid driving or operating heavy machinery if unusual drowsiness occurs.
Dizziness or fainting upon standing can occur, particularly when starting treatment; rise slowly from sitting or lying positions.
Ongentys may cause or worsen uncontrolled body movements. The levodopa dose may need to be lowered.
Hallucinations and psychotic symptoms, such as confusion, hallucinations, or delusional thinking, may occur.
Impulse control disorders, with symptoms such as unusual gambling urges, increased sexual urges, and compulsive spending or eating, may develop.
Suddenly stopping this drug may cause a rapid return of Parkinson’s symptoms or a condition resembling neuroleptic malignant syndrome, including fever and muscle stiffness.
Contraindications
Avoid taking or using this medication if any of the following apply:
- Currently taking non-selective MAO inhibitors, such as phenelzine or tranylcypromine
- Personal history of pheochromocytoma, paraganglioma, or other tumors that produce catecholamines, such as adrenaline
Side Effects
Common side effects of Ongentys include:
- Involuntary movements, also known as dyskinesia
- Constipation
- Increased blood levels of creatine kinase
- Low blood pressure or fainting
- Weight loss
Serious side effects can include sudden uncontrollable sleepiness that may occur without warning, even while driving, and severe episodes of low blood pressure.
Hallucinations, confusion, and impulse control problems, such as compulsive gambling or unusual sexual urges, have also been reported.
Stopping Ongentys suddenly may cause a rapid return of Parkinson’s symptoms or, in rare cases, a serious reaction with high fever, muscle rigidity, and confusion.
Contact a healthcare provider immediately if any unusual or serious symptoms develop.
Frequently Asked Questions about Ongentys
What is Ongentys used for?
Ongentys is a prescription medicine used as an add-on to levodopa/carbidopa in people with Parkinson’s disease who are having “off” episodes, meaning times when symptoms return as the levodopa effect wears off.
How does Ongentys work?
Ongentys is a selective, reversible COMT inhibitor. By blocking COMT, it helps reduce the breakdown of levodopa, which can help levodopa last longer and reduce fluctuations in symptom control.
How do you take Ongentys?
The usual dose is 50 mg by mouth once daily at bedtime. It should be taken without food, with no eating for 1 hour before and at least 1 hour after the dose.
What should you do if you miss a dose?
If you miss a dose, do not double up. Take your next usual dose the following day at bedtime. Patients are also advised not to stop or change the dose without speaking with their healthcare provider first.
How well does Ongentys work?
In two 14- to 15-week clinical studies, Ongentys 50 mg reduced daily “off” time significantly more than placebo, by about 0.9 to 1 hour at study endpoint. In one study it also significantly increased “on” time without troublesome dyskinesia.
What are the most common side effects?
The most common side effects reported with Ongentys include dyskinesia, constipation, increased blood creatine kinase, low blood pressure or fainting, and weight loss. Dyskinesia was also the most common side effect leading some patients to stop treatment.
What are the most important serious warnings?
Ongentys can cause sudden sleep episodes or marked drowsiness, low blood pressure or fainting, worsening dyskinesia, hallucinations or psychotic-like behavior, impulse-control problems such as gambling or compulsive spending, and fever, confusion, or severe muscle stiffness after stopping the medicine.
Who should not take Ongentys?
Ongentys is contraindicated in people taking non-selective MAO inhibitors and in people with pheochromocytoma, paraganglioma, or other catecholamine-secreting tumors. It should also be avoided in severe liver impairment, and the dose is reduced to 25 mg once daily in moderate liver impairment.
Are there important drug interactions or kidney-related precautions?
Yes. Ongentys can interact with drugs metabolized by COMT, including epinephrine, norepinephrine, dopamine, dobutamine, and isoproterenol, which may raise the risk of heart-rate or blood-pressure problems. It should be avoided in end-stage renal disease with creatinine clearance below 15 mL/min, while no dose adjustment is required for mild, moderate, or severe renal impairment.
Can children, older adults, pregnant or breastfeeding patients use Ongentys, and how should it be stored?
Safety and effectiveness in children have not been established. Older adults generally do not need a dose adjustment. In pregnancy, there are no adequate human data and animal data suggest possible fetal harm. In breastfeeding, there are no human milk data. Ongentys should be stored below 30°C (86°F).
