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Drug overview for ONGENTYS (opicapone):
Generic name: opicapone (oh-PIK-a-pone)
Drug class: Antiparkinsonian COMT Inhibitors
Therapeutic class: Central Nervous System Agents
Opicapone is a selective and reversible catechol-O-methyltransferase (COMT) inhibitor. Concomitant administration of opicapone with levodopa and a decarboxylase inhibitor (e.g., carbidopa) results in increased and more sustained plasma levodopa concentrations compared with administration of levodopa and a decarboxylase inhibitor.
No enhanced Uses information available for this drug.
Generic name: opicapone (oh-PIK-a-pone)
Drug class: Antiparkinsonian COMT Inhibitors
Therapeutic class: Central Nervous System Agents
Opicapone is a selective and reversible catechol-O-methyltransferase (COMT) inhibitor. Concomitant administration of opicapone with levodopa and a decarboxylase inhibitor (e.g., carbidopa) results in increased and more sustained plasma levodopa concentrations compared with administration of levodopa and a decarboxylase inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
ONGENTYS 25 MG CAPSULE
ONGENTYS 50 MG CAPSULE
The following indications for ONGENTYS (opicapone) have been approved by the FDA:
Indications:
Idiopathic parkinsonism
Professional Synonyms:
Paralysis agitans
Primary Parkinson's disease
Indications:
Idiopathic parkinsonism
Professional Synonyms:
Paralysis agitans
Primary Parkinson's disease
The following dosing information is available for ONGENTYS (opicapone):
No enhanced Dosing information available for this drug.
Opicapone is administered orally once daily at bedtime. Because presence of food in the GI tract may decrease exposure of opicapone, patients should not consume any food for 1 hour before and for at least 1 hour after taking the drug. (See Description.) If a dose of opicapone is missed, the next dose should be taken at the usually scheduled time the next day.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ONGENTYS 25 MG CAPSULE | Maintenance | Adults take 1 capsule (25 mg) by oral route once daily at bedtime |
| ONGENTYS 50 MG CAPSULE | Maintenance | Adults take 1 capsule (50 mg) by oral route once daily at bedtime |
No generic dosing information available.
The following drug interaction information is available for ONGENTYS (opicapone):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| COMT Inhibitors/Selected MAOIs SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Since MAOI's and COMT are the two major enzymes responsible for the metabolism of catecholamines, the combination of entacapone, tolcapone, or opicapone and a non-selective MAOI may inhibit the majority of catecholamine metabolism pathways.(1-3) CLINICAL EFFECTS: Concurrent administration of entacapone, tolcapone, or opicapone with a non-selective MAOI may result in elevated levels of catecholamines, which may result in elevated heart rate and blood pressure. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The Canadian(4) and UK(1) manufacturers of entacapone state that concomitant use of either a non-selective MAOI or a selective MAO-A inhibitor with a selective MAO-B inhibitor with entacapone is contraindicated. Nonselective MAOI should be discontinued at least 2 weeks prior to initiating entacapone therapy.(4) The UK manufacturer of tolcapone states that tolcapone should not be coadministered with either a non-selective MAOI or a selective MAO-A inhibitor with a selective MAO-B inhibitor. (5) The US manufacturer of tolcapone states that patients should not ordinarily be treated concomitantly with tolcapone and a non-selective MAOI. Tolcapone may be concurrently administered with a selective MAO-B inhibitor.(2) The Middle East and US manufacturers of opicapone state that concomitant use of opicapone with MAO inhibitors other than those for the treatment of Parkinson's disease is contraindicated.(10,11) DISCUSSION: Monoamine oxidase (MAO) and catechol-O-methyltransferase (COMT) are the two major enzymes systems involved in the metabolism of catecholamines. Therefore, theoretically, the combination of either entacapone, tolcapone, or opicapone with a non-selective MAO inhibitor will result in inhibition of the majority of catecholamine metabolism pathways.(1,2) At daily oral doses of 10 mg, selegiline is primarily a selective MAO-B inhibitor; however, at higher doses, selegiline is capable of inhibiting MAO-A.(6) At dosages administered transdermally for the treatment of depression, selegiline is not selective for MAO-B.(7) Methylene blue, when administered intravenously, has been shown to reach sufficient concentrations to be a potent inhibitor of MAO-A.(8,9) Metaxalone is a weak inhibitor of MAO.(12,13) |
EMSAM, FURAZOLIDONE, LINEZOLID, LINEZOLID-0.9% NACL, LINEZOLID-D5W, MARPLAN, MATULANE, METAXALONE, METHYLENE BLUE, NARDIL, PARNATE, PHENELZINE SULFATE, PROCARBAZINE HCL, PROVAYBLUE, SELEGILINE HCL, TRANYLCYPROMINE SULFATE, ZYVOX |
There are 0 severe interactions.
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Entacapone; Opicapone/COMT-Metabolized Agents SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Entacapone and opicapone are selective and reversible inhibitors of catechol-O-methyltransferase (COMT) and drugs that are metabolized by COMT can not be fully metabolized when given with entacapone or opicapone.(1) CLINICAL EFFECTS: COMT-metabolized agents can interact with entacapone or opicapone and may result in an increased heart rates, arrhythmias, or an excessive change in blood pressure.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturers of entacapone and opicapone recommend using caution when administering entacapone or opicapone and a COMT-metabolized agent regardless of the route of administration (including inhalation).(1-3) DISCUSSION: In an interaction study, ventricular tachycardia was observed after epinephrine and entacapone administration.(1) Another study on the effect of entacapone given with isoproterenol and epinephrine concluded that entacapone may potentiate the chronotropic and arrhythmogenic effects of isoproterenol and epinephrine.(4) |
ADRENALIN, ARTICADENT DENTAL, ARTICAINE-EPINEPHRINE, ARTICAINE-EPINEPHRINE BIT, BUFFERED LIDOCAINE-EPINEPHRINE, BUPIVACAINE HCL-EPINEPHRINE, BUPIVACAINE-DEXAMETH-EPINEPHRN, CITANEST FORTE DENTAL, DOBUTAMINE HCL, DOBUTAMINE HCL-D5W, DOPAMINE HCL, DOPAMINE HCL IN 5% DEXTROSE, DROXIDOPA, EPINEPHRINE, EPINEPHRINE BITARTR-0.9% NACL, EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE-NACL, EPINEPHRINE CONVENIENCE KIT, EPINEPHRINE HCL-0.9% NACL, EPINEPHRINE HCL-D5W, EPINEPHRINE-0.9% NACL, EPINEPHRINE-D5W, EPINEPHRINE-NACL, ISOPROTERENOL HCL, ISOPROTERENOL HCL-0.9% NACL, ISUPREL, L.E.T. (LIDO-EPINEPH-TETRA), LEVOPHED, LIDOCAINE HCL-EPINEPHRINE, LIDOCAINE HCL-EPINEPHRINE-NACL, LIDOCAINE-EPINEPHRINE, LIGNOSPAN STANDARD, MARCAINE-EPINEPHRINE, METHYLDOPA, METHYLDOPA-HYDROCHLOROTHIAZIDE, METHYLDOPATE HCL, NOREPINEPHRINE BITAR-0.9% NACL, NOREPINEPHRINE BITARTRAT-WATER, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE-D5W, NORTHERA, ORABLOC, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RACEPINEPHRINE HCL, SENSORCAINE-EPINEPHRINE, SENSORCAINE-MPF EPINEPHRINE, SEPTOCAINE, VIVACAINE, XYLOCAINE DENTAL-EPINEPHRINE, XYLOCAINE WITH EPINEPHRINE, XYLOCAINE-MPF WITH EPINEPHRINE |
| COMT Inhibitors/Rasagiline; Oral Selegiline SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Since MAOIs and COMT are the two major enzymes responsible for the metabolism of catecholamines, the combination of entacapone, tolcapone, or opicapone and a non-selective MAOI may inhibit the majority of catecholamine metabolism pathways.(1-3) CLINICAL EFFECTS: Concurrent administration of entacapone, tolcapone, or opicapone with a non-selective MAOI may result in elevated levels of catecholamines, which may result in elevated heart rate and blood pressure. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Entacapone(1,4), tolcapone(5), and opicapone(9,10) should not be used with either a non-selective MAOI or the combination of a selective MAO-A inhibitor and a selective MAO-B inhibitor. Nonselective MAOIs should be discontinued at least 2 weeks prior to initiating COMT inhibitor therapy. Entacapone, tolcapone, or opicapone may be used with oral selegiline, provided that the daily dose of selegiline does not exceed 10 mg, and with rasagiline, provided that the daily dose of rasagiline does not exceed 1 mg, and that patients are not also receiving a selective MAO-A inhibitor. DISCUSSION: Monoamine oxidase (MAO) and catechol-O-methyltransferase (COMT) are the two major enzymes systems involved in the metabolism of catecholamines. Therefore, theoretically, the combination of either entacapone or tolcapone with a non-selective MAO inhibitor will result in inhibition of the majority of catecholamine metabolism pathways.(1,2) Rasagiline is selective for MAO-B in humans at recommended dosages of 1 mg per day or less.(6) Rasagiline has been used with entacapone in clinical trials with no reports of adverse effects.(6) Concurrent administration of rasagiline and entacapone increased rasagiline oral clearance by 28%.(7) At daily doses of 10 mg, selegiline is primarily a selective MAO-B inhibitor; however, at higher doses, selegiline is capable of inhibiting MAO-A.(8) |
AZILECT, RASAGILINE MESYLATE, SELEGILINE HCL, ZELAPAR |
The following contraindication information is available for ONGENTYS (opicapone):
Drug contraindication overview.
*Concomitant use of nonselective monoamine oxidase (MAO) inhibitors. (See MAO Inhibitors under Drug Interactions.) *History of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms.
*Concomitant use of nonselective monoamine oxidase (MAO) inhibitors. (See MAO Inhibitors under Drug Interactions.) *History of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Paraganglioma |
| Pheochromocytoma |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Child-pugh class B hepatic impairment |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypotension |
The following adverse reaction information is available for ONGENTYS (opicapone):
Adverse reaction overview.
Adverse effects reported in 4% or more of patients receiving opicapone in clinical studies and at a frequency greater than placebo include dyskinesia, constipation, increased blood creatine kinase, hypotension/syncope, and weight loss.
Adverse effects reported in 4% or more of patients receiving opicapone in clinical studies and at a frequency greater than placebo include dyskinesia, constipation, increased blood creatine kinase, hypotension/syncope, and weight loss.
There are 4 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypotension |
Hallucinations Hypertension Orthostatic hypotension |
| Rare/Very Rare |
|---|
| None. |
There are 14 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Constipation Dyskinesia Syncope Weight loss |
Aggressive behavior Agitation Delusional disorder Impulse control disorder Increased creatine kinase level Insomnia Xerostomia |
| Rare/Very Rare |
|---|
|
Accidental fall Dizziness Sudden onset of sleep |
The following precautions are available for ONGENTYS (opicapone):
The safety and efficacy of opicapone have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate data on the developmental risk associated with use of opicapone in pregnant women. However, there is a possibility of fetal risk based on animal studies. Animal data showed some evidence of adverse embryofetal development at clinically relevant plasma concentrations. Structural abnormalities were seen when opicapone was administered to pregnant rabbits during organogenesis.
It is not known whether opicapone distributes into human milk or whether the drug has any effects on the breast-fed infant or on milk production. Opicapone distributes into milk in rats at concentrations similar to those in maternal plasma. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for opicapone, and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition .
Among patients who received opicapone 50 mg daily in the principal efficacy studies, 52% were 65 years of age and older. No overall differences in safety or efficacy were identified between these geriatric patients and younger patients, but increased sensitivity in some older individuals cannot be ruled out. A subgroup analysis of these studies found that rates of hallucinations and weight loss were more common in patients 70 years of age and older compared with younger patients.
The following prioritized warning is available for ONGENTYS (opicapone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ONGENTYS (opicapone)'s list of indications:
| Idiopathic parkinsonism | |
| G20 | Parkinson's disease |
| G20.A | Parkinson's disease without dyskinesia |
| G20.A1 | Parkinson's disease without dyskinesia, without mention of fluctuations |
| G20.A2 | Parkinson's disease without dyskinesia, with fluctuations |
| G20.B | Parkinson's disease with dyskinesia |
| G20.B1 | Parkinson's disease with dyskinesia, without mention of fluctuations |
| G20.B2 | Parkinson's disease with dyskinesia, with fluctuations |
| G20.C | Parkinsonism, unspecified |
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