Ongentys

Ongentys (opicapone) is a prescription medicine used to treat Parkinson's disease "off" episodes in adults. "Off" episodes are periods when Parkinson's symptoms return, such as stiffness, tremors, muscle spasms, and poor muscle control. Ongentys helps levodopa last longer in the body, so Parkinson's symptoms are better controlled throughout the day. It is always taken together with carbidopa and levodopa, and is not used on its own.

Ongentys belongs to the drug class called COMT inhibitors (catechol-O-methyltransferase inhibitors). It may also be called a dopaminergic antiparkinsonian agent.

Ongentys capsule is taken once daily at bedtime on an empty stomach. Do not eat one hour before or 1 hour after taking this medicine.

There is no generic or biosimilar for Ongentys

Ongentys works by blocking an enzyme called COMT (catechol-O-methyltransferase). In Parkinson's disease, the main treatment is levodopa, which the brain converts into dopamine. However, the body breaks down levodopa quickly before much of it can reach the brain. COMT is one of the enzymes responsible for this breakdown.

By inhibiting COMT, Ongentys slows the breakdown of levodopa, increasing and prolonging the amount of levodopa available to the brain, allowing it to work more consistently throughout the day. The result is a reduction in "off" periods, the times when Parkinson's symptoms such as stiffness and tremors return.

Ongentys is always taken alongside levodopa/carbidopa, not on its own. The two medicines complement each other by blocking different enzymes that break down levodopa. Carbidopa blocks the enzyme (DDC) while Ongentys blocks the next enzyme (COMT), keeping more levodopa available to reach the brain.

• Ongentys is taken by mouth once daily at bedtime.
• It should be taken on an empty stomach. Do not eat for at least 1 hour before or 1 hour after taking Ongentys, as food can reduce how well it is absorbed.
• Your healthcare provider will prescribe the right dose for you. Follow all directions on your prescription label.
• Do not stop or change your dose without talking to your doctor first.
• Your doctor may need to adjust your other Parkinson's medicines when you stop Ongentys.

Do not take Ongentys if you:

• Take a non-selective monoamine oxidase (MAO) inhibitor, such as isocarboxazid, phenelzine, or tranylcypromine. Do not take Ongentys within 14 days of stopping one of these medicines.
• Have a tumor that secretes catecholamine hormones, such as a pheochromocytoma (adrenal gland tumor) or paraganglioma.

To make sure Ongentys is safe for you, tell your doctor if you have:

• Daytime sleepiness or a sleep disorder, including narcolepsy or other conditions that cause sudden sleepiness
• Unusual or intense urges, such as gambling, binge eating, or compulsive shopping
• Uncontrolled muscle movements (dyskinesia)
• A history of hallucinations, psychosis, or other mental illness
• Liver disease
• Kidney disease

Also, tell your doctor if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Pregnancy

Based on animal data, Ongentys may cause harm to an unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Ongentys.

Breastfeeding

It is not known whether Ongentys passes into breast milk. You and your healthcare provider should discuss the best way to feed your baby if you need to take Ongentys.

Common side effects

The most common Ongentys side effects are:

• Uncontrolled sudden movements (dyskinesia )
• Constipation
• Elevated blood creatine kinase levels
• Low blood pressure or fainting (hypotension/syncope)
• Weight loss

Other less common side effects included dizziness, dry mouth, hallucinations, insomnia, and high blood pressure.

Falling asleep during normal activities

Ongentys may cause you to fall asleep during normal daytime activities, such as driving, working, talking, or eating, sometimes without warning or prior drowsiness. Tell your doctor right away if this happens. Avoid driving or operating machinery until you know how Ongentys affects you.

Low blood pressure (hypotension) and fainting (syncope)

Ongentys can cause low blood pressure, dizziness, lightheadedness, or fainting. This occurred in 5% of patients taking Ongentys compared to 1% on placebo in clinical trials. Tell your doctor if you feel dizzy or faint. Your doctor may need to stop Ongentys or adjust other medicines that lower blood pressure.

Uncontrolled movements (dyskinesia)

Ongentys may cause uncontrolled sudden movements or make existing movements worse. This is because Ongentys increases the effects of levodopa. Dyskinesia occurred in 20% of patients taking Ongentys compared to 6% on placebo. Your doctor may lower your levodopa dose if this occurs.

Hallucinations and psychosis

Ongentys may cause hallucinations (seeing or hearing things that are not there), delusions, or aggressive behavior. Tell your healthcare provider if you experience any of these changes. Your doctor may stop Ongentys if hallucinations or psychosis occur.

Unusual urges (impulse control and compulsive behaviors)

Some people taking Ongentys experience intense and hard-to-control urges, such as gambling, increased sexual urges, binge eating, or compulsive spending. Tell your doctor if you or a family member notices these changes.

Withdrawal symptoms

Do not stop taking Ongentys without talking to your doctor first. Stopping Ongentys suddenly may cause symptoms similar to neuroleptic malignant syndrome, including high fever, muscle stiffness, confusion, rapid heartbeat, and sweating. Your doctor may need to adjust your other Parkinson's medicines when you stop Ongentys.

These are not all possible side effects of Ongentys. Contact your doctor for medical advice, or report side effects to the FDA at 1-800-FDA-1088.

• The standard dose is 50 mg once daily at bedtime.
• If you have moderate liver problems (Child-Pugh B), your dose will be reduced to 25 mg once daily. Ongentys should not be used if you have severe liver impairment.
• Avoid using this medicine if you have end-stage renal disease (ESRD). For patients with severe renal impairment monitor for adverse reactions and discontinue Ongentys if tolerability issues arise.
• Your healthcare provider will decide how long you need to take Ongentys and will monitor you for side effects.

Stopping Ongentys: Do not stop taking Ongentys without talking to your doctor first. When stopping Ongentys, your doctor may need to adjust your other Parkinson's medicines.

Skip the missed dose and take your next dose at bedtime the following night. Do not take two doses at the same time to make up for a missed dose.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Non-selective MAO inhibitors (such as isocarboxazid, phenelzine, or tranylcypromine): Do not take Ongentys with these medicines. Using them together is contraindicated and can cause dangerous increases in catecholamine levels, including arrhythmias, rapid heart rate, and large swings in blood pressure.
• Catecholamine medicines (such as dobutamine, dopamine, epinephrine, norepinephrine, or isoproterenol): Use with caution. Ongentys can affect how these medicines are broken down and may increase the risk of heart rhythm problems and blood pressure changes.
• Medicines that make you drowsy, such as opioids, sleeping pills, muscle relaxers, or anti-anxiety medicines: Using these with Ongentys may worsen drowsiness.

Note: Selective MAO-B inhibitors (such as rasagiline and selegiline) can be used alongside Ongentys.

This list is not complete. Other drugs may interact with opicapone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed.

• Store capsules at a temperature below 86°F (30°C).
• Keep this medicine and all medicines out of the reach of children.

Ongentys (opicapone) is distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Manufactured under license from BIAL-Portela & Ca, S.A. ONGENTYS is a registered trademark of BIAL-Portela & Ca, S.A.

Active ingredient: opicapone

Inactive ingredients: lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. Capsule shells contain: FD&C Blue #2, FD&C Red #3, gelatin, and titanium dioxide.

Available as hard gelatin capsules in the following strengths:

• 25 mg: light blue opaque cap and light pink opaque body; printed with "OPC 25" in blue ink
• 50 mg: dark blue opaque cap and dark pink opaque body; printed with "OPC 50" in white ink