Uses
What is Ongentys used for?
Ongentys (opicapone) is commonly used to treat Parkinson’s disease, a condition that affects the part of your brain that controls your movements.
Ongentys may also be used for other conditions as determined by your healthcare provider.
How does Ongentys work (mechanism of action)?
Ongentys belongs to a group of medicines called catechol-O-methyltransferase (COMT) inhibitors. It is believed to slow down the breakdown of levodopa, another medicine used to treat Parkinson’s disease. This helps extend the effect of levodopa.
How is Ongentys supplied (dosage forms)?
Ongentys is available in the following dosage forms that are taken by mouth.
- 25 mg oral capsules
- 50 mg oral capsules
How should I store Ongentys?
Ongentys should be stored at a temperature below 86 F (30 C).
Side Effects
What are the most common side effects of Ongentys?
The most common side effects of Ongentys are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Uncontrollable, involuntary movements (see below)
- Constipation
- Increase in a certain enzyme called blood creatine kinase
- Low blood pressure upon standing (see below)
- Weight loss
There may be other side effects of Ongentys that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Ongentys?
While less common, the most serious side effects of Ongentys are described below, along with what to do if they happen.
Severe Allergic Reactions. Ongentys may cause allergic reactions, which can be serious. Stop taking Ongentys and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Sleepiness. Ongentys can make you sleepy, sometimes very suddenly and without warning signs. Do not drive or do other activities that require alertness or coordination until you know how Ongentys affects you.
Low Blood Pressure Upon Standing (Orthostatic Hypotension). Ongentys may cause a sudden drop in blood pressure when standing up from a seated or lying position. This may also cause fainting. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Tell your healthcare provider right away if you have any of the following symptoms of orthostatic hypotension.
- Dizziness, feeling lightheaded, or fainting upon standing
- Blurred vision
- Confusion
- Feeling weak
Uncontrollable, Involuntary Movements (Dyskinesia). Ongentys may cause or worsen involuntary movement problems, including shakiness, stiffness, or jerkiness. Call your healthcare provider right away if you develop or have worsening or more frequent unusual/uncontrolled movements.
Hallucinations or Psychotic-like Behaviors. Ongentys may cause hallucinations or psychotic-like behaviors. Tell your healthcare provider right away if you experience any of the following (either you have noticed on your own or you have been told by others).
- Hearing, seeing, smelling, tasting, or otherwise perceiving things that have turned out to be false
- Delusional thoughts (such as false belief that you are being controlled)
- Disorganized thoughts (such as jumping between topics or having a hard time focusing)
- Sudden decline in self-care (such as personal hygiene or academic/work performances)
- Aggressive behavior
Unusual or Compulsive Behaviors. Ongentys can cause some people to have strong unusual and uncontrolled urges (compulsions), including gambling, sex, shopping, or eating. Talk to your healthcare provider right away if you or someone you know notices that you have new or worsening strong urges or behaviors.
Warnings & Precautions
Who should not use Ongentys?
Allergies to Ingredients. People who are allergic to any of the following should not take Ongentys.
- Opicapone
- Ongentys
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Ongentys.
Liver Problems. Ongentys should not be taken if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to take this medicine.
Drug Interactions. Ongentys should not be taken while you are using certain other medicines. Before taking Ongentys, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Certain Types of Hormone-Releasing Tumor. Ongentys should not be used if you have a certain type of tumor that secrete hormones known as catecholamines. These include pheochromocytoma, a type of adrenal gland tumor, or another type of tumor known as paraganglioma. People with this type of tumor are more likely to experience dangerous side effects while using Ongentys compared to others.
What should I know about Ongentys before using it?
Do not take Ongentys unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Ongentys with other people, even if they have the same condition as you. It may harm them.
Keep Ongentys out of the reach of children.
Do not stop taking Ongentys without talking to your healthcare provider. Stopping too quickly may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms.
- High fever
- Muscle stiffness or rigidity, where it is hard to move
- Changes in your breathing or heart rate
- Increased sweating
- Confusion
Ongentys may cause you to feel sleepy, especially if you already have conditions or take medicines that can make you drowsy. You may feel sudden drowsiness in the middle of an activity without warning signs. Ongentys may also cause dizziness, especially when you stand up quickly after lying or sitting down. Do not drive or do other activities that require alertness or coordination until you know how Ongentys affects you.
Do not eat for 1 hour before Ongentys, and do not eat for at least 1 hour after taking Ongentys.
What should I tell my healthcare provider before using Ongentys?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ongentys is right for you.
In particular, make sure that you discuss any of the following.
Psychotic Disorder. Tell your healthcare provider if you have any psychotic disorder such as schizophrenia or delusional disorder. Ongentys may increase the risk of psychosis.
Sleepiness. Tell your healthcare provider if you have any conditions such as obstructive sleep apnea or narcolepsy that make you more sleepy than usual or if you feel that you are prone to feeling drowsy during the day. Ongentys may increase the risk of sudden daytime drowsiness.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- High or low blood pressure
- Uncontrollable, involuntary movements (dyskinesia)
- Unusual urges such as gambling, binge eating, compulsive shopping, or increased sex drive
- Liver problems
- Kidney problems
Pregnancy. It is not known if or how Ongentys could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. It is not known if Ongentys passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Ongentys while breastfeeding.
How can I get more information about Ongentys?
For more information about Ongentys, you can visit the manufacturer’s website at www.ongentys.com or call them at 877-835-5472.
Interactions
Does Ongentys interact with foods or drinks?
Food can prevent Ongentys from being properly absorbed into your body. Avoid taking Ongentys within 1 hour before and after food.
It is unknown if drinking alcohol will affect Ongentys. The risk of drowsiness or sleepiness may be increased if you drink alcohol while taking Ongentys.
Does Ongentys interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Ongentys.
- A nonselective monoamine oxidase inhibitor (MAOI), such as phenelzine (Nardil), tranylcypromine (Parnate), or isocarboxazid (Marplan), which is a medicine usually used for depression
- Isoproterenol, which is a medicine used for slow heart rate or heart block
- Epinephrine, such as Epipen, which is a medicine used for severe allergic reactions
- A catecholamine medicine such as norepinephrine, dopamine, and dobutamine, which is a medicine usually used for severely reduced blood pressure or reduced heart function
- Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety
Ongentys may alter the blood levels of some other medicines. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Ongentys. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Ongentys?
If you or someone else has used too much Ongentys, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Ongentys?
If you miss a dose, take the next dose at the scheduled time the next day. Do not take double or extra doses.
Are you currently using Ongentys (opicapone)?
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