Ongentys

The active ingredient in Ongentys is opicapone, which is a catechol-O-methyltransferase (COMT) inhibitor. COMT is a protein in your body that breaks down levodopa, a typical Parkinson's medicine. This reduces the effects of levodopa in treating Parkinson's disease symptoms, which are caused by low dopamine levels in the brain.

Ongentys blocks COMT, allowing levodopa to reach and maintain higher levels in the body. This means that more levodopa can be turned into dopamine in the brain, thereby relieving Parkinson's disease symptoms.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-approved product Labeling, Instructions for Use, and Medication Guide before using Ongentys. However, the following is a synopsis of the general guidelines for the use of Ongentys:

Ongentys is typically taken at bedtime. Follow your doctor's dosing recommendations carefully.

Take Ongentys on an empty stomach. Avoid eating for at least 1 hour before or after taking this medication.

Your blood pressure may need to be tested regularly.

Ongentys may cause you to fall asleep while doing routine everyday activities, including working, talking, eating, or driving. Even if you feel aware, you may fall asleep suddenly. Inform your doctor if you have daytime tiredness or drowsiness.

Do not modify your doses or discontinue any of your medications without your doctor's approval. Inform your doctor if any of your medications appear to have stopped working.

The most common side effects of Ongentys seen in clinical trials as compared to placebo include:

• Constipation.
• Weight loss.
• Dry mouth.
• Dizziness or lightheadedness (syncope).
• Increase in a certain enzyme called blood creatine kinase.

Some individuals may experience serious side effects while using Ongentys. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Excessive sleepiness.
• Low blood pressure (hypotension) symptoms like dizziness, lightheadedness, fatigue, and feeling faint (syncope).
• Hallucinations or changes in your behavior. This includes irritability, aggressive behavior, and impulse control or unusual urges like gambling, engaging in sexual activity, binge eating, or spending money.
• An allergic reaction to the medication.
• Withdrawal symptoms such as rigid or stiff muscles, fever, and confusion if Ongentys is stopped suddenly.

These are not all of the possible side effects of Ongentys. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Ongentys, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Pheochromocytoma (adrenal gland tumor).
• Paraganglioma (nerve-cell tumor).
• A sleep problem like narcolepsy that leads to daytime drowsiness.
• Uncontrolled muscular motions or a history of uncontrolled, sudden movements (dyskinesia).
• Unusual and extreme cravings to act on impulse (such as gambling, binge eating, or compulsive shopping).
• Mental disease, hallucinations, and psychosis.
• Liver disease.
• Kidney disease.

• Take Ongentys (opicapone) alongside an MAO inhibitor (eg, phenelzine, isocarboxazid, tranylcypromine).
• People who have a tumor that secretes hormones called catecholamines.

Ongentys (opicapone) appears to act fast, with significant reductions in "off-time" observed as early as one week following treatment. These improvements persisted for the next two weeks before stabilizing.

When Ongentys is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Dobutamine.
• Epinephrine
• Norepinephrine.
• Isoproterenol.
• Dopamine.

The usual dose is 50 mg taken orally once per day at bedtime.

For those with moderate liver issues, the normal dose is 25 mg taken orally once per day.

If you miss a dose, skip the missed dose and take your next dose the following night. Do not use two doses at the same time.

Store at room temperature and keep out of reach of children.

Ongentys is a registered trademark of BIAL - Portela & CA, S.A.

There are no generic versions of Ongentys available.

Do not stop taking Ongentys without consulting your doctor. Stopping too quickly may cause withdrawal symptoms such as fever, confusion, and rigid or stiff muscles.

It is not known if Ongentys is safe to use while pregnant. Based on animal data, however, it may cause harm to your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known if Ongentys passes into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.