Indications 

Ongentys is a prescribed medication used in combination with levodopa/carbidopa as an adjunctive treatment for patients with Parkinson’s disease (PD) who experience “off” episodes. These “off” episodes refer to the period when the effects of carbidopa/levodopa medication diminish, leading to the reappearance of PD movement symptoms. 

Classified as a catechol-O-methyltransferase (COMT) inhibitor, Ongentys works by obstructing the activity of COMT, a natural substance responsible for metabolizing levodopa in the body. This action enhances the efficacy of levodopa and carbidopa, facilitating increased delivery to the brain, where their therapeutic effects are exerted. 

Uses and Dosage 

Before taking Ongentys and with each prescription refill, carefully review its medication guide and patient information leaflet. Ask your doctor or pharmacist if you have questions or concerns. 

The dosage of Ongentys is based on the patient’s medical condition and response to the treatment. 

Typically, Ongentys is taken once daily at bedtime on an empty stomach, as prescribed by the doctor. Refrain from consuming food for at least one hour before and one hour after taking this medication. 

For optimal results, take this medication around the same times daily, exactly as directed. Do not alter the prescribed dosage and frequency of intake without consulting your doctor. 

Talk to your doctor before discontinuing Ongentys, as sudden cessation may result in adverse reactions (such as fever or severe muscle rigidity) and exacerbate Parkinson’s symptoms. 

Side Effects 

Listed below are the potential adverse effects of Ongentys. If any of them last or worsen, promptly notify your physician. 

Common Side Effects 

• Feeling light-headed 
• Uncontrolled muscle movement 
• Abnormal blood tests 
• Constipation 
• Weight loss 

Serious Side Effects 

• A sensation of lightheadedness, potentially leading to fainting 
• Confusion and hallucinations  
• Aggression, agitation, or abnormal thoughts and behavior 
• Involuntary muscle movements in the face (such as chewing, lip smacking, frowning, tongue movement, blinking, or eye movement) 
• Worsening of tremors, stiffness, or muscle spasms 

Inform your doctor right away if any of the severe side effects listed above are experienced. 

Allergic Reactions 

Although rare, a severe allergic reaction to Ongentys may occur. Seek immediate medical help if you observe any of these symptoms: 

• Hives 
• Difficult breathing 
• Swelling (face, lips, throat, or tongue) 

Not all side effects of Ongentys are included in this list. Inform your physician promptly if any unlisted effects are observed. 

Cautions 

Before starting treatment with Ongentys, inform your doctor and pharmacist of any known allergies, particularly to opicapone, other drugs, or any of the components of Ongentys capsule. 

To ensure Ongentys is safe for you, disclose to your physician your medical background, especially if you have a history of: 

• Kidney problems 
• Liver problems 
• Mental/mood problems (e.g., psychosis, hallucinations) 
• Sleep disorders 
• Uncontrolled sudden movements 
• Certain types of tumors (e.g., pheochromocytoma, paraganglioma) 

Inform your doctor and pharmacist about all prescription and non-prescription medications, vitamins, and herbal supplements you are currently taking or planning to take to prevent drug interaction with Ongentys. 

Taking MAO inhibitors with Ongentys may result in a severe and potentially fatal drug interaction. Avoid using certain MAO inhibitors during treatment, such as: 

• Isocarboxazid 
• Linezolid 
• Metaxalone  
• Methylene blue  
• Moclobemide  
• Phenelzine 
• Procarbazine  
• Tranylcypromine 

Most MAO inhibitors should not be taken two weeks before treatment with Ongentys. However, certain MAO inhibitors like rasagiline, safinamide, and selegiline may be used with careful monitoring by a doctor. 

Inspect the labels of all your medications, including allergy and cough-and-cold products, as they may contain sedative components. To ensure safe usage of such products, consult with your pharmacist. 

Inform your healthcare provider if you are taking any other products that induce drowsiness, including: 

• Opioid pain or cough relievers 
• Alcohol 
• Marijuana  
• Drugs for sleep or anxiety 
• Muscle relaxants 
• Antihistamines 

The use of Ongentys may result in dizziness, lightheadedness, and fainting upon sudden rising from a prone position, particularly during initial medication intake. To prevent this, gradually rise from bed and rest your feet on the floor for a few minutes before standing up. 

Refrain from operating machinery or engaging in risky behavior until you are aware of the impact of this medication. Sudden dizziness or sleepiness may result in slips, mishaps, or grave harm. 

Ongentys may induce daytime sleepiness, causing unexpected episodes of falling asleep while performing routine activities like working, talking, eating, or driving. This sudden onset of sleepiness can occur despite feeling awake and alert. Inform your doctor of any issues with drowsiness or daytime sleepiness. 

The use of Ongentys during pregnancy should be limited to situations where it is deemed necessary. Consult your doctor to assess this medication’s potential risks and benefits. 

The transfer of opicapone into breast milk is uncertain. Prior to breastfeeding, seek advice from your physician.