Ongentys
opicapone · Capsule · Oral
Uses
1 INDICATIONS AND USAGE ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ONGENTYS is a catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ( 1 )
Dosage and administration
The recommended dosage is 50 mg administered orally once daily at bedtime. ( 2.1 ) Patients should not eat food for 1 hour before and for at least 1 hour after intake of ONGENTYS. ( 2.1 ) The recommended dosage in patients with moderate hepatic impairment is 25 mg orally once daily at bedtime; avoid use in patients with severe hepatic impairment. ( 2.2 ) 2.1 Dosing and Administration Information The recommended dosage of ONGENTYS is 50 mg administered orally once daily at bedtime. Patients should not eat food for 1 hour before and for at least 1 hour after intake of ONGENTYS [see Clinical Pharmacology ( 12.3 )]. 2.2 Dosage Recommendations for Patients with Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh B), the recommended dose of ONGENTYS is 25 mg orally once daily at bedtime [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )]. Avoid use of ONGENTYS in patients with severe (Child-Pugh C) hepatic impairment [ see Use in Specific Populations ( 8.7 ) , Clinical Pharmacology ( 12.3 ) ]. 2.3 D iscontinuation and Missed Dose When discontinuing ONGENTYS, monitor patients and consider adjustment of other dopaminergic therapies as needed. If a dose of ONGENTYS is missed, the next dose should be taken at the scheduled time the next day.
Dosage forms and strengths
3 DOSAGE FORMS AND STRENGTHS ONGENTYS capsules are available in the following strengths: 50 mg capsules with a dark blue opaque cap and dark pink opaque body; axially printed with “OPC” over “50” in white ink, on both the cap and body. 25 mg capsules with a light blue opaque cap and light pink opaque body; axially printed with “OPC” over “25” in blue ink, on both the cap and body. Capsules: 25 mg and 50 mg. ( 3 )
Contraindications
4 CONTRAINDICATIONS ONGENTYS is contraindicated in patients with: Concomitant use of non-selective monoamine oxidase (MAO) inhibitors [ see Drug Interactions ( 7.1 ) ] . Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. Concomitant use of non-selective monoamine oxidase (MAO) inhibitors. ( 4 ) History of pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. ( 4 )
Warnings and precautions
Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT): May cause arrhythmias, increased heart rate, and excessive changes in blood pressure. Monitor patients when treated concomitantly with products metabolized by COMT. ( 4 , 5.1 ) Falling Asleep During Activities of Daily Living: Advise patients prior to treatment. ( 5.2 ) Hypotension/Syncope: If occurs, consider discontinuing ONGENTYS or adjusting dosage of other medications that can lower blood pressure. ( 5.3 ) Dyskinesia: May cause or exacerbate dyskinesia; consider levodopa or dopaminergic medication dose reduction. ( 5.4 ) Hallucinations and Psychosis: Consider stopping ONGENTYS if occurs. ( 5.5 ) Impulse Control/Compulsive Disorders: Consider stopping ONGENTYS if occurs. ( 5.6 ) Withdrawal-Emergent Hyperpyrexia and Confusion: When discontinuing ONGENTYS, monitor patients and consider adjustment of other dopaminergic therapies as needed. ( 5.7 ) 5.1 Cardiovascular Effects with Concomitant Use of Drugs Metabol ized by Catechol-O-Methyltransferase (COMT) Possible arrhythmias, increased heart rate, and excessive changes in blood pressure may occur with concomitant use of ONGENTYS and drugs metabolized by COMT (e.g., isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of the route of administration (including inhalation). Monitor patients treated concomitantly with ONGENTYS and drugs metabolized by COMT [see Contraindications ( 4 ), Drug Interactions ( 7.1 , 7.2 )] . 5.2 Falling Asleep During Activities of Daily Living and Somnolence Patients treated with dopaminergic medications and medications that increase levodopa exposure, including ONGENTYS, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. Patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event. Before initiating treatment with ONGENTYS, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with dopaminergic therapy, such as concomitant sedating medications or the presence of a sleep disorder. If a patient develops daytime sleepiness or episodes of falling asleep during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), consider discontinuing ONGENTYS or adjusting other dopaminergic or sedating medications. If a decision is made to continue ONGENTYS, patients should be advised not to drive and to avoid other potentially dangerous activities. 5.3 Hypotension/Syncope In Study 1 and Study 2 [see Clinical Studies ( 14 )] , hypotension (orthostatic and non-orthostatic), syncope, and presyncope occurred in 5% of patients treated with ONGENTYS 50 mg compared to 1% of patients who received placebo. Monitor patients for hypotension (orthostatic and non-orthostatic) and advise patients about the risk for syncope and presyncope. If these adverse reactions occur, consider discontinuing ONGENTYS or adjusting the dosage of other medications that can lower blood pressure. 5.4 Dyskinesia ONGENTYS potentiates the effects of levodopa [see Clinical Pharmacology ( 12.3 )] and may cause dyskinesia or exacerbate pre-existing dyskinesia. In controlled clinical trials (Study 1 and Study 2) [see Clinical Studies ( 14 )], dyskinesia occurred in 20% of patients treated with ONGENTYS 50 mg compared to 6% of patients who received placebo. Dyskinesia was also the most common adverse reaction leading to discontinuation of ONGENTYS [see Adverse Reactions ( 6.1 )]. Reducing the patient’s daily levodopa dosage or the dosage of another dopaminergic drug may mitigate dyskinesia that occurs during treatment with ONGENTYS. 5.5 Hallucinations and Psychosis In Study 1 and Study 2, hallucinations (hallucinations, auditory hallucinations, visual hallucinations, mixed hallucinations) occurred in 3% of patients treated with ONGENTYS 50 mg compared to 1% of patients who received placebo. Delusions, agitation, or aggressive behavior occurred in 1% of patients treated with ONGENTYS 50 mg, and in no patient who received placebo. Consider stopping ONGENTYS if hallucinations or psychotic-like behaviors occur. Patients with a major psychotic disorder should ordinarily not be treated with ONGENTYS because of the risk of exacerbating the psychosis with an increase in central dopaminergic tone. In addition, treatments for psychosis that antagonize the effects of dopaminergic medications may exacerbate the symptoms of PD . 5.6 Impulse Control / Compulsive Disorders Patients treated with ONGENTYS can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more dopaminergic therapies that increase central dopaminergic tone. In some cases, these urges were reported to have stopped when the dose was reduced, or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with ONGENTYS. In Study 1 and Study 2, impulse control disorders occurred in 1% of patients treated with ONGENTYS 50 mg, and in no patient who received placebo. Re-evaluate the patient’s current therapy(ies) for Parkinson’s disease and consider stopping ONGENTYS if a patient develops such urges while taking ONGENTYS. Use with caution in Parkinson’s patients with suspected or diagnosed dopamine dysregulation syndrome.
Side effects
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT) [see Warnings and Precautions ( 5.1 )] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.2 )] Hypotension/Syncope [see Warnings and Precautions ( 5.3 )] Dyskinesia [see Warnings and Precautions ( 5.4 )] Hallucinations and Psychosis [see Warnings and Precautions ( 5.5 )] Impulse Control/Compulsive Disorders [see Warnings and Precautions ( 5.6 )] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥4% and > placebo): dyskinesia, constipation, blood creatine kinase increased, hypotension/syncope, and weight decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ONGENTYS was evaluated in 265 patients with Parkinson’s disease (PD) in two 14-15 week placebo- and active-controlled (Study 1) or placebo-controlled (Study 2) studies [see Clinical Studies ( 14 )] . All patients were taking a stable dose of levodopa and a DOPA decarboxylase inhibitor, alone or in combination with other PD medications. In Study 1 and Study 2, the mean age of patients was 63.6 years, 59% of patients were male, and 89% of patients were Caucasian. At baseline, the mean duration of PD was 7.6 years. Adverse Reactions Leading to Discontinuation of Treatment In Study 1 and Study 2, a total of 8% of ONGENTYS 50 mg-treated patients and 6% of patients who received placebo discontinued due to adverse events. The most common adverse reaction leading to discontinuation was dyskinesia, reported in 3% of ONGENTYS 50 mg-treated patients and 0.4% of patients who received placebo. Common Adverse Reactions Adverse reactions that occurred in the pooled studies at an incidence of at least 2% and greater than placebo are presented in Table 1. The most common adverse reactions (incidence at least 4% and greater than placebo) were dyskinesia, constipation, blood creatine kinase increased, hypotension/syncope, and weight decreased. Table 1 : Adverse Reactions with an Incidence of at Least 2 % in Patients Treated with ONGENTYS and Greater than on Placebo, in Pooled Study 1 and Study 2 Adverse Reactions ONGENTYS 50 mg N=265 % Placebo N=257 % Nervous system disorders Dyskinesia Dizziness 20 3 6 1 Gastrointestinal disorders Constipation Dry mouth 6 3 2 1 Psychiatric disorders Hallucination 1 Insomnia 3 3 1 2 Investigations Blood creatine kinase increased Weight decreased 5 4 2 0 Vascular disorders Hypotension/syncope 2 Hypertension 5 3 1 2 1 Includes hallucinations, hallucinations visual, hallucinations auditory, and hallucinations mixed 2 Includes hypotension, orthostatic hypotension, syncope, and presyncope 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ONGENTYS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Injury, poisoning and procedural complications: Fall Psychiatric disorder : Confusional state
Drug interactions
7.1 Non-Selective Monoamine Oxidase (MAO) Inhibitors Both ONGENTYS and non-selective MAO inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine) inhibit catecholamine metabolism, leading to increased levels of catecholamines. Concomitant use may increase the risk of possible arrhythmias, increased heart rate, and excessive changes in blood pressure. Concomitant use of ONGENTYS with non-selective MAO inhibitors is contraindicated [see Contraindications ( 4 )] . Selective MAO-B inhibitors can be used concomitantly with ONGENTYS. 7.2 Effect of ONGENTYS on Other Drugs Drugs Metabolized by Catechol-O-Methyltransferase (COMT) Concomitant use of ONGENTYS with drugs metabolized by COMT may affect the pharmacokinetics of those drugs, which may increase the risk of possible arrhythmias, increased heart rate, and excessive changes in blood pressure [see Warnings and Precautions ( 5.1 )] . Drugs known to be metabolized by COMT should be administered with caution. Monitor for changes in heart rate, rhythm, and blood pressure in patients concomitantly treated with ONGENTYS and drugs metabolized by COMT [see Warnings and Precautions ( 5.1 )] .
Use in specific populations
Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ) Avoid use in patients with end-stage renal disease. ( 8.6 ) 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of ONGENTYS in pregnant women. In animal studies, oral administration of opicapone during pregnancy resulted in adverse effects on embryofetal development (increased incidence of fetal abnormalities) at clinically relevant plasma exposures in one of two species tested. In addition, opicapone is always given concomitantly with levodopa/carbidopa, which is known to cause developmental toxicity in rabbits ( s ee Data ). The background risk of major birth defects and miscarriage in the U.S. general population is 2-4% and 15-20% of clinically recognized pregnancies, respectively. The background risk for major birth defects and miscarriage in patients with Parkinson’s disease is unknown. Data Animal Data Oral administration of opicapone (0, 150, 375, or 1000 mg/kg/day) to pregnant rats throughout gestation resulted in no adverse effects on embryofetal development. Plasma exposure (AUC) at the highest dose tested (1000 mg/kg/day) was approximately 40 times that in humans at the recommended human dose (50 mg/day). In pregnant rabbits, oral administration of opicapone (0, 100, 175, or 225 mg/kg/day) during the period of organogenesis resulted in increased incidence of structural abnormalities at all doses tested; maternal toxicity was observed at all but the lowest dose tested. A no-effect dose for adverse effects on embryofetal development was not identified. Plasma exposure (AUC) at the low-effect dose (100 mg/kg/day) was less than that in humans at the RHD. Oral administration of opicapone (0, 150, 375, or 1000 mg/kg/day) throughout gestation and lactation resulted in no adverse effects on pre- and postnatal development; however, effects on neurobehavioral development in the offspring were not rigorously assessed. Plasma exposure (AUC) at the highest dose tested (1000 mg/kg/day) was approximately 40 times that in humans at the RHD. Opicapone is always given concomitantly with levodopa/carbidopa, which is known to cause visceral and skeletal malformations in rabbits. The developmental toxicity of opicapone in combination with levodopa/carbidopa was not assessed in animals. 8.2 Lactation Risk Summary There are no data on the presence of opicapone in human milk, the effects on the breastfed infant, or the effects on milk production. In lactating rats, oral administration of opicapone resulted in levels of opicapone or metabolites in milk similar to those in maternal plasma . 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. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use No dose adjustment is required for elderly patients. Of the total number of patients who received ONGENTYS 50 mg in Study 1 and Study 2, 52% of patients were 65 years and older. No overall differences in safety and effectiveness were observed between these patients and younger patients, but greater sensitivity to adverse reactions of some older individuals cannot be ruled out. 8.6 Renal Impairment The renal route of elimination plays a minor role in the clearance of opicapone [see Clinical Pharmacology ( 12.3 )]. Avoid use of ONGENTYS in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min). No dosage adjustment is required for patients with mild, moderate, or severe renal impairment. However, because of a potential for increased exposure, monitor patients with severe renal impairment for adverse reactions and discontinue ONGENTYS if tolerability issues arise. 8. 7 Hepatic Impairment Opicapone exposure is increased in patients with hepatic impairment [see Clinical Pharmacology ( 12.3 )] . Avoid use of ONGENTYS in patients with severe (Child-Pugh C) hepatic impairment. Dosage adjustment is recommended for patients with moderate (Child-Pugh B) hepatic impairment [see Dosage and Administration ( 2.2 )] . No dosage adjustment is required in patients with mild (Child-Pugh A) hepatic impairment.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of ONGENTYS in pregnant women. In animal studies, oral administration of opicapone during pregnancy resulted in adverse effects on embryofetal development (increased incidence of fetal abnormalities) at clinically relevant plasma exposures in one of two species tested. In addition, opicapone is always given concomitantly with levodopa/carbidopa, which is known to cause developmental toxicity in rabbits ( s ee Data ). The background risk of major birth defects and miscarriage in the U.S. general population is 2-4% and 15-20% of clinically recognized pregnancies, respectively. The background risk for major birth defects and miscarriage in patients with Parkinson’s disease is unknown. Data Animal Data Oral administration of opicapone (0, 150, 375, or 1000 mg/kg/day) to pregnant rats throughout gestation resulted in no adverse effects on embryofetal development. Plasma exposure (AUC) at the highest dose tested (1000 mg/kg/day) was approximately 40 times that in humans at the recommended human dose (50 mg/day). In pregnant rabbits, oral administration of opicapone (0, 100, 175, or 225 mg/kg/day) during the period of organogenesis resulted in increased incidence of structural abnormalities at all doses tested; maternal toxicity was observed at all but the lowest dose tested. A no-effect dose for adverse effects on embryofetal development was not identified. Plasma exposure (AUC) at the low-effect dose (100 mg/kg/day) was less than that in humans at the RHD. Oral administration of opicapone (0, 150, 375, or 1000 mg/kg/day) throughout gestation and lactation resulted in no adverse effects on pre- and postnatal development; however, effects on neurobehavioral development in the offspring were not rigorously assessed. Plasma exposure (AUC) at the highest dose tested (1000 mg/kg/day) was approximately 40 times that in humans at the RHD. Opicapone is always given concomitantly with levodopa/carbidopa, which is known to cause visceral and skeletal malformations in rabbits. The developmental toxicity of opicapone in combination with levodopa/carbidopa was not assessed in animals.
Pediatric use
8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric use
8.5 Geriatric Use No dose adjustment is required for elderly patients. Of the total number of patients who received ONGENTYS 50 mg in Study 1 and Study 2, 52% of patients were 65 years and older. No overall differences in safety and effectiveness were observed between these patients and younger patients, but greater sensitivity to adverse reactions of some older individuals cannot be ruled out.
Overdosage
No specific antidotes for ONGENTYS are known. As a general measure, removal of ONGENTYS by gastric lavage and/or inactivation by administering activated charcoal should be considered. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. If an over-exposure occurs, call your poison control center at 1-800-222-1222 or www.poison.org.
Description
11 DESCRIPTION ONGENTYS contains opicapone, a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. The chemical name of opicapone is 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide with the following structure: The opicapone molecular formula is C15H10Cl2N4O6; and its molecular weight is 413.17. Opicapone is a yellow powder/crystalline solid with limited aqueous solubility. ONGENTYS capsules are intended for oral administration. Each capsule contains 25 mg or 50 mg of opicapone. ONGENTYS also contains the following inactive ingredients: lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The capsule shells contain: FD&C Blue#2, FD&C Red#3, gelatin, and titanium dioxide. ONGENTYS contains opicapone, a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. The chemical name of opicapone is 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide with the following structure:
Mechanism of action
12.1 Mechanism of Action Opicapone is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT). COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure. Physiological substrates of COMT include DOPA, catecholamines (dopamine, norepinephrine, and epinephrine), and their hydroxylated metabolites. When decarboxylation of levodopa is prevented by carbidopa, COMT becomes the major metabolizing enzyme for levodopa, catalyzing its metabolism to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).
How supplied
16.1 How Supplied ONGENTYS (opicapone) capsules are available as:
• 50 mg hard gelatin capsules, Size 1; dark blue opaque cap and dark pink opaque body; axially printed with “OPC” over “50” in white ink, on both the cap and body - Bottle of 30 with child-resistant closure: NDC 64896-403-01
• 25 mg hard gelatin capsules, Size 1; light blue opaque cap and light pink opaque body; axially printed with “OPC” over “25” in blue ink, on both the cap and body - Bottle of 30 with child-resistant closure: NDC 64896-402-01 16.2 Storage and Handling Store at a temperature below 30°C (86°F). 16.1 How Supplied ONGENTYS (opicapone) capsules are available as:
• 50 mg hard gelatin capsules, Size 1; dark blue opaque cap and dark pink opaque body; axially printed with “OPC” over “50” in white ink, on both the cap and body - Bottle of 30 with child-resistant closure: NDC 64896-403-01
• 25 mg hard gelatin capsules, Size 1; light blue opaque cap and light pink opaque body; axially printed with “OPC” over “25” in blue ink, on both the cap and body - Bottle of 30 with child-resistant closure: NDC 64896-402-01
Storage
16.2 Storage and Handling Store at a temperature below 30°C (86°F).
Patient information
Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Administration Instruct patients and/or caregivers that ONGENTYS capsules should be taken at bedtime. Inform patients to not eat food for 1 hour before and for at least 1 hour after intake of ONGENTYS [see Dosage and Administration ( 2.1 )] . Concomitant Medications Certain medications can cause an interaction with ONGENTYS. Advise patients and/or caregivers to inform their healthcare provider of all the medicines the patient is taking, including over-the-counter medicines, dietary supplements, and herbal products [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7 )] . Falling Asleep During Activities of Daily Living Advise patients and/or caregivers that somnolence has been reported with ONGENTYS. Patients treated with dopaminergic medications have reported falling asleep while engaged in activities of daily living. These adverse reactions may affect some patients’ ability to drive and operate machinery safely [see Warnings and Precautions ( 5.2 )] . Hypotension/Syncope Advise patients that ONGENTYS may cause hypotension or syncope [see Warnings and Precautions ( 5.3 )]. Dyskinesia Advise patients that ONGENTYS may cause dyskinesia or exacerbate pre-existing dyskinesia [see Warnings and Precautions ( 5.4 )]. Hallucinations and Psychosis Advise patients that ONGENTYS may cause hallucinations, delusions, or aggressive behavior and they should report any of these adverse reactions to their healthcare provider [see Warnings and Precautions ( 5.5 )]. Impulse Control /Compulsive Disorders Inform patients of the potential for experiencing intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and other intense urges and the inability to control these urges while taking ONGENTYS and one or more medications that increase central dopaminergic tone that are generally used for the treatment of PD. Advise patients that they should report any of these adverse reactions to their healthcare provider [see Warnings and Precautions ( 5.6 )] . Withdrawal-Emergent Hyperpyrexia and Confusion Advise patients to contact their healthcare provider before stopping ONGENTYS. Tell patients to inform their healthcare provider if they develop symptoms such as fever, confusion, or severe muscle stiffness after stopping ONGENTYS [see Warnings and Precautions ( 5.7 )] . For further information on ONGENTYS, call 1-877-835-5472 or visit www.ongentys.com Distributed by: Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2025-02 Under license from BIAL-Portela & C a , S.A. ONGENTYS is a registered trademark of BIAL-Portela & C a , S.A.
Label text from the FDA structured product label by Amneal Pharmaceuticals LLC (revised Oct 15, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Opicapone in 2 products
Ongentys NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 64896-402 | Opicapone 25 mg/1 Capsule | Amneal Pharmaceuticals LLC | NDA |
| 64896-403 | Opicapone 50 mg/1 Capsule | Amneal Pharmaceuticals LLC | NDA |
Frequently asked questions
What is Ongentys used for?
1 INDICATIONS AND USAGE ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ONGENTYS is a catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ( 1 )
What are the side effects of Ongentys?
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT) [see Warnings and Precautions ( 5.1 )] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.2 )] Hypotension/Syncope [see Warnings… See the full label for the complete list.
Who makes Ongentys?
Ongentys is listed by 1 labeler in the FDA NDC directory, including Amneal Pharmaceuticals LLC.