Ongentys 50mg Capsules
It is used to treat Parkinson's disease.
Drug Class
Antiparkinsonian agent
Pharmacologic Class
Catechol-O-methyltransferase (COMT) inhibitor
Pregnancy Category
Not assigned; refer to special populations section for detailed information.
FDA Approved
Apr 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ongentys is a medication used to help people with Parkinson's disease who are taking levodopa/carbidopa. It works by helping your body use levodopa more effectively, which can reduce the amount of 'off' time (when your symptoms return) you experience throughout the day.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Take your medication at bedtime, as directed. Additionally, do not eat food for at least 1 hour before or 1 hour after taking your medication. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or misuse.
What to Do If You Miss a Dose
If you miss a dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed dose.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Take your medication at bedtime, as directed. Additionally, do not eat food for at least 1 hour before or 1 hour after taking your medication. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or misuse.
What to Do If You Miss a Dose
If you miss a dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed dose.
Lifestyle & Tips
- Take Ongentys once daily at bedtime, at least one hour after your last dose of levodopa/carbidopa.
- Do not take Ongentys with non-selective MAO inhibitors (e.g., phenelzine, tranylcypromine, isocarboxazid) due to serious interaction risk.
- If you take iron supplements, separate the dose of Ongentys by at least one hour.
- Be aware of potential side effects such as dizziness, lightheadedness, or sudden sleepiness, especially when starting the medication. Avoid driving or operating machinery until you know how it affects you.
- Report any new or worsening unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping) to your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg orally once daily at bedtime, at least one hour after the last daily dose of levodopa/carbidopa.
Dose Range:
50 - 50 mg
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
Not studied; use with caution.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Not recommended due to limited clinical experience.
Pharmacology
Mechanism of Action
Opicapone is a reversible, selective, and potent peripheral catechol-O-methyltransferase (COMT) inhibitor. It reduces the peripheral metabolism of levodopa, leading to increased plasma concentrations of levodopa and prolonged levodopa exposure. This results in more sustained dopaminergic stimulation in the brain, which helps to reduce 'off' time in Parkinson's disease patients treated with levodopa/carbidopa.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified, but well absorbed.
Tmax:
Approximately 1.5 to 2 hours.
FoodEffect:
A high-fat meal decreases Cmax by 60% and AUC by 42%. Should be taken at least one hour after levodopa/carbidopa.
Distribution:
Vd:
Approximately 100 L.
ProteinBinding:
Greater than 99% (primarily to albumin).
CnssPenetration:
Limited (primarily acts peripherally).
Elimination:
HalfLife:
Approximately 1-2 hours (terminal half-life of parent drug), but pharmacological effect lasts longer due to irreversible COMT inhibition.
Clearance:
Not available
ExcretionRoute:
Primarily fecal (60-70%), with renal excretion accounting for 20-30%.
Unchanged:
Less than 1% (renal).
Pharmacodynamics
OnsetOfAction:
Clinical effects typically observed within days to weeks of initiation.
PeakEffect:
Steady-state plasma concentrations are reached within 4-5 days.
DurationOfAction:
Approximately 24 hours (supports once-daily dosing).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Hallucinations (seeing or hearing things that are not there)
Changes in behavior
Strong, uncontrollable urges (such as excessive eating, gambling, sex, or spending money)
New or worsening trouble controlling body movements
Neuroleptic malignant syndrome (NMS), a rare but potentially deadly condition that can occur when this medication is stopped suddenly or the dose is lowered. Symptoms of NMS include:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or abnormal heartbeat
+ Excessive sweating
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
* Weight loss
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Hallucinations (seeing or hearing things that are not there)
Changes in behavior
Strong, uncontrollable urges (such as excessive eating, gambling, sex, or spending money)
New or worsening trouble controlling body movements
Neuroleptic malignant syndrome (NMS), a rare but potentially deadly condition that can occur when this medication is stopped suddenly or the dose is lowered. Symptoms of NMS include:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or abnormal heartbeat
+ Excessive sweating
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
* Weight loss
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (orthostatic hypotension)
- New or worsening uncontrolled movements (dyskinesia)
- Hallucinations or confusion
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality, binge eating)
- Excessive daytime sleepiness or sudden onset of sleep
- Severe nausea or vomiting
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms.
Certain health conditions, including kidney disease or liver disease.
The presence of specific tumors, such as pheochromocytoma (a tumor on the adrenal gland) or paraganglioma (another type of tumor).
If you are currently taking any of the following medications: isocarboxazid, phenelzine, or tranylcypromine.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms.
Certain health conditions, including kidney disease or liver disease.
The presence of specific tumors, such as pheochromocytoma (a tumor on the adrenal gland) or paraganglioma (another type of tumor).
If you are currently taking any of the following medications: isocarboxazid, phenelzine, or tranylcypromine.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution when climbing stairs.
Be aware that this medication can cause sudden sleepiness, even if you feel alert beforehand. Some individuals have fallen asleep unexpectedly while engaging in daily activities like driving, eating, or conversing. If you experience sudden sleepiness or fall asleep during activities, do not operate vehicles or engage in tasks that require alertness. Immediately contact your doctor if you experience excessive sleepiness or sudden sleep episodes.
Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of this medication to both you and your baby to make an informed decision.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution when climbing stairs.
Be aware that this medication can cause sudden sleepiness, even if you feel alert beforehand. Some individuals have fallen asleep unexpectedly while engaging in daily activities like driving, eating, or conversing. If you experience sudden sleepiness or fall asleep during activities, do not operate vehicles or engage in tasks that require alertness. Immediately contact your doctor if you experience excessive sleepiness or sudden sleep episodes.
Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Exaggerated adverse effects such as severe dyskinesia, orthostatic hypotension, hallucinations, or excessive sedation.
What to Do:
There is no specific antidote. Treatment should be symptomatic and supportive. Call 911 or Poison Control at 1-800-222-1222 immediately.
Drug Interactions
Contraindicated Interactions
- Non-selective monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine, isocarboxazid) due to risk of hypertensive crisis.
Major Interactions
- Drugs metabolized by COMT (e.g., isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine) - Opicapone may increase their exposure and potential for adverse effects.
- Other COMT inhibitors (e.g., entacapone, tolcapone) - Concomitant use is not recommended.
Moderate Interactions
- Iron salts (e.g., ferrous sulfate, iron gluconate) - May form chelates with opicapone, reducing its absorption. Administer opicapone at least 1 hour before or after iron preparations.
- Dopamine agonists (e.g., pramipexole, ropinirole, rotigotine) - May require dose adjustment of dopamine agonists due to increased dopaminergic stimulation.
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To establish baseline and monitor for orthostatic hypotension.
Timing: Prior to initiation.
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: Although not primarily hepatically metabolized, good clinical practice for new medications.
Timing: Prior to initiation.
Renal Function (eGFR, Creatinine)
Rationale: To assess baseline kidney function.
Timing: Prior to initiation.
Routine Monitoring
Dyskinesia
Frequency: Regularly, especially during dose titration of levodopa.
Target: Minimize severity.
Action Threshold: If severe or bothersome, consider reducing levodopa dose or other symptomatic management.
Orthostatic Hypotension
Frequency: Regularly, especially during initial treatment and dose changes.
Target: Maintain stable blood pressure.
Action Threshold: If symptomatic, advise patient on non-pharmacological measures; consider dose adjustment of other hypotensive agents or opicapone if severe.
Hallucinations/Psychotic Behavior
Frequency: Regularly.
Target: Absence or minimal.
Action Threshold: If present, assess severity and consider dose reduction or discontinuation.
Impulse Control Disorders (ICDs)
Frequency: Regularly, inquire about new or worsening behaviors.
Target: Absence.
Action Threshold: If new or worsening, consider dose reduction or discontinuation.
Sleep Disorders (e.g., somnolence, sudden onset of sleep)
Frequency: Regularly.
Target: Absence or minimal.
Action Threshold: If present, advise caution with driving/operating machinery; consider dose reduction or discontinuation.
Symptom Monitoring
- Changes in motor fluctuations (e.g., 'off' time reduction)
- New or worsening dyskinesia
- Dizziness or lightheadedness (orthostatic hypotension)
- Hallucinations, delusions, or other psychotic symptoms
- Unusual urges or behaviors (e.g., gambling, hypersexuality, binge eating, compulsive shopping)
- Excessive daytime sleepiness or sudden onset of sleep
- Nausea, vomiting, constipation, or other gastrointestinal disturbances
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Ongentys in pregnant women. Animal studies have shown developmental toxicity (e.g., skeletal abnormalities, reduced fetal weight) at doses higher than clinical exposure. Ongentys should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal data.
Second Trimester:
Potential for developmental toxicity based on animal data.
Third Trimester:
Potential for developmental toxicity based on animal data.
Lactation
It is not known whether opicapone is excreted in human milk. Opicapone and its metabolites were excreted in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ONGENTYS and any potential adverse effects on the breastfed infant from ONGENTYS or from the underlying maternal condition.
Infant Risk:
Unknown in humans; potential for adverse effects based on animal data.
Pediatric Use
The safety and effectiveness of Ongentys in pediatric patients have not been established.
Geriatric Use
No dose adjustment is required based on age. Clinical studies included patients 65 years and older, and no overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Clinical Information
Clinical Pearls
- Opicapone is an adjunctive therapy to levodopa/carbidopa for Parkinson's disease patients experiencing 'off' episodes.
- It is crucial to take Ongentys at bedtime, at least one hour after the last levodopa dose, to optimize its effect and minimize food interactions.
- Patients should be monitored for new or worsening dyskinesia, orthostatic hypotension, hallucinations, and impulse control disorders, as these can be exacerbated by increased dopaminergic stimulation.
- Avoid concomitant use with non-selective MAO inhibitors due to the risk of hypertensive crisis.
- No dose adjustment is needed for renal impairment, but caution is advised in severe hepatic impairment.
Alternative Therapies
- Other COMT inhibitors (e.g., entacapone, tolcapone)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- Dopamine agonists (e.g., pramipexole, ropinirole, rotigotine, apomorphine)
- Amantadine
- Istradefylline
Cost & Coverage
Average Cost:
Highly variable, typically >$1000 per 30 capsules
Insurance Coverage:
Tier 3 or 4 (Non-preferred brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.