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Safety

Adverse Reactions

ONGENTYS WAS GENERALLY WELL TOLERATED IN CLINICAL STUDIES1

In the pooled analysis of 2 double-blind studies

Adverse reactions in Study 1 and Study 2 that occurred at an incidence of ≥2% AND GREATER THAN PLACEBO in patients taking ONGENTYS® (opicapone) capsules1:

Adverse ReactionPlacebo
(N=257) %		ONGENTYS 50 mg
(N=265) %
Dyskinesia620
Dizziness13
Constipation26
Dry mouth13
Hallucination*13
Insomnia23
Blood creatine kinase increased25
Weight decreased04
Hypotension/syncope†15
Hypertension23

ONGENTYS can be used with most concomitant PD treatments1‡§

*Includes hallucinations, hallucinations visual, hallucinations auditory, and hallucinations mixed.1

†Includes hypotension, orthostatic hypotension, syncope, and presyncope.1

‡Concomitant use of ONGENTYS with nonselective MAO inhibitors (eg, phenelzine, isocarboxazid, and tranylcypromine) is contraindicated.1

§ONGENTYS can be taken concomitantly with selective MAO-B inhibitors used to treat PD (eg, rasagiline and selegiline).1

MAO=monoamine oxidase; MAO-B=monoamine oxidase-B; PD=Parkinson's disease.

Managing Dyskinesia

In clinical studies, most dyskinesia events were mild to moderate2-4

Discontinuation rates due to adverse events in the double-blind period were 8% for patients taking ONGENTYS and 6% for patients taking placebo. Discontinuation due to dyskinesia was reported in 3% of patients taking ONGENTYS and 0.4% of patients taking placebo1

  • After the initial 2- to 3-week CD/LD adjustment period, dyskinesia rates were 8.3% for ONGENTYS and 1.6% for placebo5

Because ONGENTYS optimizes levodopa, it may mean that you need to adjust your patient's dose and/or frequency of levodopa if they're experiencing dyskinesia1

CD=carbidopa; LD=levodopa.

Other Adverse Events

OTHER ADVERSE EVENTS OF SPECIAL INTEREST5

In the pooled analysis of 2 double-blind studies

Adverse ReactionPlacebo
(N=257) % (n)		ONGENTYS 50 mg
(N=265) % (n)
Urine discoloration0.0 (0)0.0 (0)
Diarrhea1.9 (5)2.3 (6)
Sleep attacks and somnolence3.5 (9)1.9 (5)
Impulse control disorders0.0 (0)1.1 (3)
Depression1.2 (3)1.1 (3)
Depressed mood0.4 (1)0.4 (1)
Depressive symptom0.0 (0)0.0 (0)

Safety Considerations

Safety Considerations

Drug Interactions
  • Concomitant use of ONGENTYS with nonselective MAO inhibitors (eg, phenelzine, isocarboxazid, and tranylcypromine) is contraindicated1
  • ONGENTYS can be taken concomitantly with selective MAO-B inhibitors used to treat PD (eg, rasagiline and selegiline)1
  • ONGENTYS may affect the pharmacokinetics of co-administered drugs metabolized by COMT1
  • ONGENTYS did not affect the pharmacokinetics of co-administered rasagiline, selegiline, pramipexole, ropinirole, or amantadine1
  • ONGENTYS did not affect the pharmacokinetics of co-administered S-warfarin, R-warfarin, or repaglinide1

COMT=catechol-O-methyltransferase; MAO=monoamine oxidase; MAO-B=monoamine oxidase-B; PD=Parkinson's disease.

Hepatotoxicity

Overall, the incidence of hepatotoxicity adverse events of special interest was low (1.1% [n=3] for patients taking ONGENTYS and 3.1% [n=8] for patients taking placebo)5

  • Most events were mild or moderate in severity and 1 event (hepatic enzyme increased in a placebo patient) was severe5
  • For patients with moderate hepatic impairment,* the recommended dose of ONGENTYS is 25 mg, as the mean overall plasma exposure of ONGENTYS increased in those patients1
    • No dose change for mild hepatic impairment1†
    • ONGENTYS has not been studied in patients with severe hepatic impairment. Avoid use in these patients1‡

*Child-Pugh B.1

†Child-Pugh A.1

‡Child-Pugh C.1

Simple, once-daily dosing

EXPLORE DOSING

Important Information

INDICATION & USAGE

ONGENTYS® (opicapone) capsules is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ONGENTYS is contraindicated in patients with:

  • Concomitant use of non-selective monoamine oxidase (MAO) inhibitors.
  • Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.

WARNINGS & PRECAUTIONS

Cardiovascular Effects with Concomitant Use of Drugs Metabolized 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, regardless of the route of administration (including inhalation). Monitor patients treated concomitantly with ONGENTYS and drugs metabolized by COMT.

Falling Asleep During Activities of Daily Living and Somnolence - Patients have reported falling asleep while engaged in activities of daily living, including driving, which may result in accidents. Consider discontinuing ONGENTYS or adjusting other dopaminergic/sedating medications. Advise patients to avoid driving and other potentially dangerous activities.

Hypotension/Syncope - Monitor patients for hypotension and advise patients about the risk for syncope. If necessary, consider discontinuing ONGENTYS or adjusting the dosage of other medications that can lower blood pressure.

Dyskinesia - ONGENTYS may cause or exacerbate dyskinesia. Consider levodopa or dopaminergic medication dose reduction.

Hallucinations and Psychosis - Consider stopping ONGENTYS if these occur. Patients with a major psychotic disorder should ordinarily not be treated with ONGENTYS.

Impulse Control/Compulsive Disorders - Patients may experience intense urges (eg, gambling, sexual, spending money, binge eating) and the inability to control them. It is important for prescribers to ask about the development of new or increased urges. Monitor for occurrence of intense urges and consider discontinuing ONGENTYS if they occur.

Withdrawal-Emergent Hyperpyrexia and Confusion - A symptom complex resembling neuroleptic malignant syndrome can develop with rapid dose reduction or withdrawal of drugs that increase central dopaminergic tone. When discontinuing ONGENTYS, monitor patients and consider adjustment of dopaminergic therapies as needed.

ADVERSE REACTIONS

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see ONGENTYS full Prescribing Information.

References:

  1. ONGENTYS [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2023.
  2. Lees A, Ferreira JJ, Rocha JF, et al. Safety profile of opicapone in the management of Parkinsons disease. J Parkinsons Dis. 2019;9(4):733-740.
  3. Ferreira JJ, Lees A, Rocha JF, et al. Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. Published December 22, 2015. doi:10.1016/S1474-4422(15)00336-1
  4. Lees AJ, Ferreira J, Rascol O, et al; BIPARK-2 Study Investigators. Opicapone as adjunct to levodopa therapy in patients with Parkinson's disease and motor fluctuations: a randomized clinical trial. JAMA Neurol. 2017;74(2):197-206.
  5. Data on file. Amneal Pharmaceuticals LLC.