Opicapone

What is Opicapone?

Opicapone (ONGENTYS) is a catechol-O-methyltransferase (COMT) inhibitor used with levodopa and carbidopa in people with Parkinson’s disease (PD) who are having “OFF” episodes.

What are the uses of this medicine?

This medicine is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

How does this medicine work?

• Opicapone is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT).
• COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure. Physiological substrates of COMT include DOPA, catecholamines (dopamine, norepinephrine, and epinephrine), and their hydroxylated metabolites.
• When decarboxylation of levodopa is prevented by carbidopa, COMT becomes the major metabolizing enzyme for levodopa, catalyzing its metabolism to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).

Who Should Not Use this medicine ?

• This medicine cannot be used in patient with:
• History of pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.

What drug interactions can this medicine cause?

• Concomitant use of ONGENTYS with non-selective MAO inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine) is contraindicated.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

Recommended Dosage

• The recommended dosage is 50 mg administered orally once daily at bedtime.
• Patients should not eat food for 1 hour before and for at least 1 hour after intake of ONGENTYS.
• The recommended dosage in patients with moderate hepatic impairment is 25 mg orally once daily at bedtime; avoid use in patients with severe hepatic impairment.

Administration Take ONGENTYS exactly as your healthcare provider tells you to. • ONGENTYS should be taken 1 time each day at bedtime. • Do not eat 1 hour before taking ONGENTYS and do not eat for at least 1 hour after taking ONGENTYS. • If you miss a dose, take your usual dose of ONGENTYS on the next day at bedtime. • Do not stop taking ONGENTYS or change your dose before talking to your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 25 mg and 50 mg

This medicine is available in fallowing brand namesː

• ONGENTYS

What side effects can this medication cause?

Common possible side effects and laboratory abnormalities of this medicine include:

• uncontrolled sudden movements (dyskinesia)
• constipation
• increase in a certain enzyme called blood creatine kinase
• low blood pressure
• weight loss

ONGENTYS may cause serious side effects, including:

• Falling asleep during normal activities
• Low blood pressure or dizziness
• Uncontrolled sudden movements (dyskinesia)
• Seeing, hearing, believing, or feeling things that are not real or not true(hallucinations) (delusions)
• Unusual urges (impulse control and compulsive disorders)

What special precautions should I follow?

• Possible arrhythmias, increased heart rate, and excessive changes in blood pressure may occur with concomitant use of ONGENTYS and drugs metabolized by COMT (e.g., isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of the route of administration (including inhalation). Monitor patients treated concomitantly with ONGENTYS and drugs metabolized by COMT.
• Patients treated with dopaminergic medications and medications that increase levodopa exposure, including ONGENTYS, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. Before initiating treatment with ONGENTYS, advise patients of the potential to develop drowsiness.
• Hypotension/Syncope may occur. If occurs, consider discontinuing ONGENTYS or adjusting dosage of other medications that can lower blood pressure.
• This medicine may cause exacerbate dyskinesia; consider levodopa or dopaminergic medication dose reduction.
• This medicine may cause hallucinations and psychosis. Consider stopping ONGENTYS if occurs
• Impulse Control/Compulsive Disorders may occur. Consider stopping ONGENTYS if occurs.
• When discontinuing ONGENTYS, monitor patients and consider adjustment of other dopaminergic therapies as needed.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with use of ONGENTYS in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store at a temperature below 30°C (86°F).

• Dailymed label info on Opicapone
• FDA Opicapone

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