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PATIENT PROFILES

IDENTIFYING APPROPRIATE PATIENTS FOR ONGENTYS

DO YOU HAVE PATIENTS LIKE ROBERT OR AMELIA IN YOUR PRACTICE WHO MIGHT BENEFIT FROM ONGENTYS?

INTRODUCING ROBERT, A 65-YEAR-OLD PATIENT WITH PD

Lifestyle considerations

  • Works as a school administrator and wants to continue working until age 70
  • Plays poker with his friends and goes to water aerobics once a week; enjoys dining out with his wife (care partner)

Clinical background

  • Diagnosed with PD 4 years ago

Treatment history

  • Levodopa
    • At diagnosis: treated with IR CD/LD 25mg/100 mg TID
    • 2 years later: increased to 2 tablets of IR CD/LD 25 mg/100 mg TID
  • 6 months ago, added entacapone 200 mg TID

Patient and care partner concerns

  • Seeing only partial improvement with end-of-dose wearing “Off“
  • Feels self-conscious about his care partner finding orange stains on his underwear
  • Worried about increasing his dose and/or frequency of IR CD/LD
  • Care partner also notes he has complained about intestinal cramping occurring most days, along with mild diarrhea
Patient Robert Patient Robert
How might switching from entacapone to ONGENTYS help a patient like Robert meet his goals?

INTRODUCING AMELIA, A 68-YEAR-OLD PATIENT WITH PD

Lifestyle considerations

  • Enjoys hiking and volunteering; helps with a weekly youth craft night at her local library

Clinical background

  • Diagnosed with PD 2.5 years ago
  • Symptoms included difficulty walking and balance problems
  • Current non-PD medications: anticoagulant, beta blocker, and calcium channel blocker for atrial fibrillation 
    and hypertension

Treatment history

  • Started on 1 tablet of IR CD/LD 25 mg/100 mg TID, then increased to 1.5 tablets of IR CD/LD 
    25 mg/100 mg TID to maintain symptom control
  • 2 years after diagnosis, she experienced end-of-dose wearing “Off” 30–45 minutes before each dose of IR CD/LD. She was switched to 3 capsules of RYTARY® (carbidopa and levodopa) extended-release capsules* 23.75 mg/95 mg TID
  • Experienced delayed “On” with RYTARY* and missed “the kick” of IR CD/LD

Patient and care partner concerns

  • At her request, she has switched back to IR CD/LD, with a recommendation to increase the dose frequency to 4 times a day
  • Patient and care partner have expressed concerns about increasing the dose frequency, as she is already having difficulty maintaining adherence with a TID dose regimen

*RYTARY® is a registered trademark of Amneal Pharmaceuticals LLC.

Patient Amelia Patient Amelia
How might adding once-daily ONGENTYS help a patient like Amelia optimize her IR CD/LD regimen?

CD/LD=carbidopa/levodopa; IR=immediate-release; PD=Parkinson’s disease; TID=three times daily.

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.