Ongentys 25mg Capsules
It is used to treat Parkinson's disease.
Drug Class
Antiparkinsonian agent, COMT inhibitor
Pharmacologic Class
Catechol-O-methyltransferase (COMT) inhibitor
Pregnancy Category
Not available
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 helps your levodopa medicine work better and for a longer time, which can reduce the amount of 'off' time (when your Parkinson's symptoms return). It works by blocking an enzyme in your body that breaks down levodopa.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at bedtime, and avoid eating food for at least 1 hour before and 1 hour after taking it. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets, to prevent accidental ingestion.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at bedtime, and avoid eating food for at least 1 hour before and 1 hour after taking it. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets, to prevent accidental ingestion.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one.
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) as this can cause a dangerous increase in blood pressure.
- Be aware of potential side effects like dizziness or lightheadedness, especially when standing up quickly, and report them to your doctor.
- Report any new or worsening uncontrolled movements (dyskinesia) as your levodopa dose may need adjustment.
- Report any new or unusual urges or behaviors (e.g., gambling, shopping, sexual urges) as these can be side effects of Parkinson's medications.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg orally once daily at bedtime, at least one hour after levodopa/carbidopa
Dose Range:
50 - 50 mg
Condition-Specific Dosing:
Parkinson's Disease (adjunctive to levodopa/carbidopa):
50 mg orally once daily at bedtime
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:
Use with caution in patients with end-stage renal disease (ESRD) due to lack of data.
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
Not recommended
Severe:
Not recommended
Pharmacology
Mechanism of Action
Opicapone is a selective and reversible 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 allows more levodopa to reach the brain, where it is converted to dopamine, thereby improving motor fluctuations in Parkinson's disease patients treated with levodopa/carbidopa.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30%
Tmax:
1 to 2 hours
FoodEffect:
Food reduces Cmax by 60% and AUC by 42%. Opicapone should be taken at least one hour after levodopa/carbidopa.
Distribution:
Vd:
Approximately 30 L
ProteinBinding:
>99% (primarily to albumin)
CnssPenetration:
Limited (primarily acts peripherally)
Elimination:
HalfLife:
Approximately 10-12 hours (functional half-life of COMT inhibition is longer, ~24 hours)
Clearance:
Primarily hepatic
ExcretionRoute:
Fecal (approximately 70%), Renal (approximately 20%)
Unchanged:
Less than 1% in urine
Pharmacodynamics
OnsetOfAction:
Within the first dose (COMT inhibition)
PeakEffect:
Sustained COMT inhibition throughout the 24-hour dosing interval
DurationOfAction:
Approximately 24 hours (due to sustained COMT inhibition)
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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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:
- New or worsening uncontrolled movements (dyskinesia)
- Dizziness or lightheadedness, especially when standing up (orthostatic hypotension)
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors (e.g., compulsive gambling, increased sexual urges, compulsive shopping, binge eating)
- Severe or persistent diarrhea
- Nausea
- Excessive sleepiness or sudden onset of sleep
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 that occurred.
Certain health conditions, including:
+ Kidney disease
+ Liver disease
+ Pheochromocytoma, a type of tumor on the adrenal gland
+ Paraganglioma, another type of tumor
If you are currently taking any of the following medications:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products
Vitamins
* Any health problems you have
Your doctor will help you determine whether it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting 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 that occurred.
Certain health conditions, including:
+ Kidney disease
+ Liver disease
+ Pheochromocytoma, a type of tumor on the adrenal gland
+ Paraganglioma, another type of tumor
If you are currently taking any of the following medications:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products
Vitamins
* Any health problems you have
Your doctor will help you determine whether it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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 navigating 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 activities like driving, eating, or conversation. If you experience sudden sleepiness or fall asleep during daily activities, do not operate a vehicle 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 taper off the dosage 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 navigating 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 activities like driving, eating, or conversation. If you experience sudden sleepiness or fall asleep during daily activities, do not operate a vehicle 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 taper off the dosage 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:
- Hypotension (low blood pressure)
- Dyskinesia (uncontrolled movements)
- Nausea
- Vomiting
- Diarrhea
What to Do:
In case of overdose, call your doctor or poison control center immediately. For the US, call 1-800-222-1222. Treatment is supportive and symptomatic. There is no specific antidote. Hemodialysis is unlikely to be effective due to high protein binding.
Drug Interactions
Contraindicated Interactions
- Non-selective monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine, isocarboxazid)
- Patients with pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms
Major Interactions
- Non-selective MAO inhibitors (risk of hypertensive crisis)
- Drugs metabolized by COMT (e.g., isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine) - risk of increased heart rate, arrhythmias, blood pressure changes
Moderate Interactions
Minor Interactions
- Not specifically identified as minor, but general caution with drugs affecting blood pressure or CNS.
Monitoring
Baseline Monitoring
Blood pressure (sitting and standing)
Rationale: To assess for baseline orthostatic hypotension risk and guide monitoring during treatment.
Timing: Prior to initiation
Liver function tests (ALT, AST, bilirubin)
Rationale: Although not a primary concern like with tolcapone, it's good practice, especially if there's a history of hepatic impairment.
Timing: Prior to initiation (if clinically indicated)
Routine Monitoring
Motor symptoms (e.g., dyskinesia, 'off' time)
Frequency: Regularly, at each follow-up visit
Target: Improvement in 'off' time, manageable dyskinesia
Action Threshold: Significant increase in dyskinesia may require levodopa dose reduction; inadequate 'off' time improvement may require re-evaluation of therapy.
Blood pressure (orthostatic)
Frequency: Periodically, especially during initial titration or if symptoms of dizziness/fainting occur
Target: Stable blood pressure, no significant orthostatic drop
Action Threshold: Symptomatic orthostatic hypotension or significant drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) may require dose adjustment of antihypertensives or re-evaluation of opicapone.
Psychiatric symptoms (e.g., hallucinations, delusions, impulse control disorders)
Frequency: Regularly, at each follow-up visit
Target: Absence or control of symptoms
Action Threshold: New onset or worsening of psychiatric symptoms may require dose reduction or discontinuation of opicapone or other dopaminergic agents.
Gastrointestinal symptoms (e.g., nausea, diarrhea)
Frequency: As needed, if reported by patient
Target: Absence or manageable symptoms
Action Threshold: Persistent or severe symptoms may require symptomatic treatment or re-evaluation of therapy.
Symptom Monitoring
- Dyskinesia (new onset or worsening)
- Orthostatic hypotension (dizziness, lightheadedness, fainting)
- Hallucinations
- Delusions
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Nausea
- Diarrhea
- Sleepiness/somnolence
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Opicapone in pregnant women. Animal studies have shown adverse developmental effects (e.g., skeletal malformations, reduced fetal weight) at exposures higher than those achieved clinically. 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 abnormalities based on animal data.
Second Trimester:
Potential for developmental abnormalities based on animal data.
Third Trimester:
Potential for developmental abnormalities based on animal data.
Lactation
There are no data on the presence of opicapone in human milk, the effects on the breastfed infant, or the effects on milk production. Opicapone and its metabolites are excreted in the milk of lactating rats. Because of the potential for serious adverse reactions in breastfed infants, including effects on growth and development, advise women not to breastfeed during treatment with Ongentys.
Infant Risk:
Potential for serious adverse reactions, including effects on growth and development. Advise against breastfeeding.
Pediatric Use
The safety and effectiveness of Ongentys in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (âĨ65 years) and younger subjects. No specific dose adjustment is required based on age, but elderly patients may be more susceptible to adverse reactions such as orthostatic hypotension and hallucinations.
Clinical Information
Clinical Pearls
- Opicapone is a once-daily COMT inhibitor, offering convenience compared to multi-dose entacapone.
- Always take Ongentys at bedtime, at least one hour after the last levodopa/carbidopa dose, to optimize absorption and minimize food interaction.
- Monitor for dyskinesia, as opicapone enhances levodopa effects; levodopa dose reduction may be necessary.
- Be vigilant for orthostatic hypotension, especially in patients on antihypertensives or with pre-existing cardiovascular conditions.
- Counsel patients on the potential for impulse control disorders and psychiatric symptoms, which are common with dopaminergic therapies.
- Unlike tolcapone, opicapone does not require routine liver function monitoring, but caution is advised in moderate to severe hepatic impairment.
Alternative Therapies
- Entacapone (another COMT inhibitor, taken with each levodopa dose)
- Tolcapone (another COMT inhibitor, requires liver monitoring)
- Safinamide (MAO-B inhibitor, adjunctive therapy)
- Rasagiline (MAO-B inhibitor, adjunctive therapy)
- Selegiline (MAO-B inhibitor, adjunctive therapy)
- Dopamine agonists (e.g., pramipexole, ropinirole, rotigotine)
- Amantadine (for dyskinesia and 'off' time)
- Istradefylline (adenosine A2A receptor antagonist, adjunctive therapy)
Cost & Coverage
Average Cost:
$1000 - $1500+ per 30 capsules (50mg)
Insurance Coverage:
Tier 3 or Tier 4 (Specialty/Non-Preferred Brand)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take medication prescribed to someone else. It's also important to note that some medications may have additional patient information leaflets, so be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. 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 information about the medication taken, the amount, and the time it occurred, as this will help healthcare professionals provide the best possible care.