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Dosing

SIMPLE, ONCE-DAILY DOSING

ONGENTYS: SIMPLE, ONCE-DAILY CAPSULE, TAKEN AT BEDTIME1

  • No food icon

    Do not take with food1

    • Patients should not eat food for 1 hour before and at least 1 hour after taking ONGENTYS® (opicapone) capsules1
    • Food reduces absorption. When ONGENTYS was taken with a moderate-fat/moderate-calorie meal, its mean peak plasma concentration decreased by 62% and its mean overall exposure decreased by 31%1
  • Bedtime dosing icon

    Once-daily, 50-mg standard dose at bedtime1

    • Patients with moderate hepatic impairment should use a 25-mg capsule, as the mean overall plasma exposure of ONGENTYS increased in these patients1,2*
    • Bedtime dosing may enable minimal disruption to patients' daily routines1
  • Pill and Capsule icon

    Works with patients' existing CD/LD dosing regimens2

    • Patients can start ONGENTYS without having to change their current CD/LD regimens2
    • Most patients in clinical studies were able to maintain stable CD/LD dosing through 1 year2
    • If patient experiences dyskinesia, a dose frequency or strength adjustment to the foundational CD/LD therapy may be needed2

*ONGENTYS has not been studied in patients with severe hepatic impairment. Avoid use in these patients.1

CD=carbidopa; LD=levodopa.

Initiating ONGENTYS

CONSIDERATIONS WHEN INITIATING ONGENTYS†

For patients taking entacapone1,3

In a clinical trial, when patients taking entacapone in the double-blind period switched to ONGENTYS in the open-label period:

  1. Patients stopped taking entacapone after the last dose of CD/LD was administered
  2. The same day, patients took ONGENTYS at bedtime (without food)
  3. The next day, patients continued taking CD/LD as scheduled and took ONGENTYS once daily at bedtime (without food)

For patients taking other adjunctive treatments1,2

In clinical trials:

  1. Patients took ONGENTYS once daily at bedtime (without food)
  2. Patients continued taking their selective MAO-B inhibitors and dopamine agonists as prescribed

†The recommended starting dose of ONGENTYS is 50 mg for patients without moderate hepatic impairment. Participants in this clinical trial (BIPARK-1) were initially switched to 25 mg for the first week of the open-label phase.1,2

CD=carbidopa; LD=levodopa; MAO-B=monoamine oxidase-B.

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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:

  1. ONGENTYS [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2023
  2. Data on file. Amneal Pharmaceuticals LLC.
  3. Ferreira J, Lees A, Santos A, Hernandez B, Rocha JF, Soares-da-Silva P. How to switch from entacapone to opicapone based on BIPARK-I study experience. Poster presented at: 2017 International Congress of the International Parkinson and Movement Disorder Society (MDS); June 4-8, 2017; Vancouver, BC.