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Optimize Levodopa with ONGENTYS1,2

ONGENTYS® (opicapone) capsules is the early levodopa/carbidopa partner that may allow patients to stay on their current levodopa dose

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Impact of COMT

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Increased Levodopa Exposure

ONGENTYS increased levodopa trough concentrations and overall levodopa exposure.1-3

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Earlier Use Subgroups

In the earlier stages of levodopa treatment and disease state, ONGENTYS reduced off time.4,5

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Patient Support

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ONGENTYS NEWS

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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:

footnotes

  1. ONGENTYS [package insert]. San Diego, CA: Neurocrine Biosciences, Inc; 2020.
  2. Data on file. Neurocrine Biosciences, Inc.
  3. Brooks DJ. Optimizing levodopa therapy for Parkinson’s disease with levodopa/carbidopa/entacapone: implications from a clinical and patient perspective. Neuropsychiatr Dis Treat. 2008;4(1):39-47.
  4. Rocha J-F, Ebersbach G, Lees A, et al. The added benefit of opicapone when used early in Parkinson’s disease patients with levodopa-induced motor fluctuations: a post-hoc analysis of BIPARK-1 and -11. Front Neurol. 2021;12:754016. doi: 10.3389/fneur.2021.754016
  5. Ferreira JJ, Poewe W, Antonini A, et al. Opicapone as first-line adjunctive levodopa treatment in Parkinson’s disease patients with motor fluctuations: findings from BIPARK-I and II combined post-hoc analysis. Poster presented at the 2020 International Congress of Parkinson’s Disease and Movement Disorders (MDS Virtual Congress); September 12-16, 2020; Virtual Congress.