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Frequently Asked Questions

Remember to talk to your doctor about any questions you may have about ONGENTYS

ONGENTYS is a prescription medicine used with carbidopa/levodopa (CD/LD) in people with Parkinson's disease (PD) who are having "off" episodes. It is not known if ONGENTYS is safe and effective in children.

Do not take ONGENTYS if you:

  • Take a type of medicine called a nonselective monoamine-oxidase (MAO) inhibitor, such as phenelzine, isocarboxazid, or tranylcypromine. Ask your healthcare provider or pharmacist if you are taking a nonselective MAO inhibitor
  • Have a tumor that secretes hormones known as catecholamines. These tumors include pheochromocytoma (a type of adrenal gland tumor) and paraganglioma

In Parkinson's disease, there are two major enzymes that break down levodopa, DDC=DOPA decarboxylase.  and COMT=catechol-O-methyltransferase. .

The DDC enzyme is blocked by carbidopa, a DDC inhibitor, when paired with levodopa. However, COMT may still be breaking down some of your levodopa before it reaches the brain.

By blocking the COMT enzyme from breaking down levodopa, once-daily ONGENTYS allows for more of the levodopa you're already taking to be available to reach the brain.

Before taking ONGENTYS, tell your healthcare provider about all of your medical conditions, including if you:

  • Have daytime sleepiness from a sleep disorder, have unexpected or unpredictable periods of sleep or sleepiness, take a medicine to help you sleep, or take any medicine that makes you feel sleepy
  • Have or have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping
  • Have a history of uncontrolled sudden movements (dyskinesia)
  • Have or have had hallucinations or psychosis
  • Have liver problems
  • Have kidney problems
  • Are pregnant or plan to become pregnant. It is not known if ONGENTYS will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if ONGENTYS passes into breast milk. You and your healthcare provider should decide the best way to feed your baby if you take ONGENTYS

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take nonselective monoamine-oxidase (MAO) inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection).

ONGENTYS and other medicines may affect each other, causing side effects. ONGENTYS may affect the way other medicines work, and other medicines may affect how ONGENTYS works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS affects you.

Your individual results may vary. In clinical studies, adding ONGENTYS reduced daily "Off" time is when symptoms, such as stiffness or tremors, return between regular doses of medication. "Off" time can happen when your carbidopa/levodopa is wearing off.  by an average of about 2 hours compared to about 1 hour for people taking CD/LD without ONGENTYS at 14–15 weeks.

Not only did ONGENTYS reduce daily "off" time during the first 14–15 weeks of clinical studies, but the majority of people taking ONGENTYS had no changes to their CD/LD dosing through 1 year.

ONGENTYS may cause serious side effects, including:

  • Falling asleep during normal activities, such as driving a car, talking, or eating while taking ONGENTYS or other medicines used to treat Parkinson's disease, without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while taking ONGENTYS are higher if you take other medicines that cause drowsiness
  • Low blood pressure or dizziness, lightheadedness, or fainting
  • Uncontrolled sudden movements (dyskinesia). ONGENTYS may cause uncontrolled sudden movements or make such movements worse or happen more often
  • Seeing, hearing, or feeling things that are not real (hallucinations), believing things that are not real (delusions), or aggressive behavior
  • Unusual urges (impulse control and compulsive disorders), such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges

Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior.

The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.

These are not all of the possible side effects of ONGENTYS. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1‑800‑FDA‑1088.

Take ONGENTYS exactly as your healthcare provider tells you to. ONGENTYS should be taken 1 time each day at bedtime. Do not eat for 1 hour before taking ONGENTYS, and do not eat for at least 1 hour after taking ONGENTYS.

If you miss a dose, take your usual dose of ONGENTYS on the next day at bedtime. Do not stop taking ONGENTYS or change your dose before talking to your healthcare provider.

Your dose of other Parkinson's disease medicines may change when stopping ONGENTYS. Tell your healthcare provider if you have symptoms of withdrawal such as fever, confusion, or severe muscle stiffness.

If you take too much ONGENTYS, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest emergency room right away.

ONGENTYS works with your existing CD/LD routine. In clinical studies, the majority of people taking ONGENTYS did not have to change their CD/LD dosing regimen through 1 year. Your individual results may vary.

If you experience dyskinesia while taking ONGENTYS, tell your healthcare provider, as they may need to adjust your CD/LD dosage or other medications.

With the ONGENTYS Savings Program, you may be eligible for a $25 copay on your ONGENTYS prescription.* If you do not have prescription coverage for ONGENTYS, you may be able to receive your prescription at no cost through the Amneal Patient Assistance Program.†‡

For more information about either of these programs, call 1‑877‑764‑9021, 9 AM–6 PM ET, Monday through Friday.

*Maximum benefit of $100.

This card is not valid for prescriptions submitted for reimbursement to Medicare, Medicaid, other federal or state programs (including any state pharmaceutical assistance programs), or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. This card is good for use only with an ONGENTYS prescription at the time the prescription is filled by the pharmacist and dispensed to the patient. Offer good only in the USA at participating retail pharmacies. Void if prohibited by law, taxed, or restricted. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. This card is good for up to 3 prescription fills per month.

Subject to eligibility requirements.

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