Opicapone

WHY is this medicine prescribed?

Opicapone is used along with levodopa and carbidopa (Sinemet, Rytary) to treat the end-of-dose 'wearing-off' symptoms of Parkinson's disease. Opicapone is an inhibitor of catechol-O-methyltransferase (COMT). Opicapone helps the levodopa and carbidopa work better by allowing more of it to reach the brain, where it has its effects.

HOW should this medicine be used?

Opicapone comes as a capsule to take by mouth. It is usually taken once a day at bedtime and should be taken at least 1 hour before or 1 hour after eating. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take opicapone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Opicapone controls Parkinson's disease but does not cure it. Continue to take opicapone even if you feel well. Do not stop taking opicapone without talking to your doctor. If you suddenly stop taking opicapone, you could develop a serious syndrome that causes fever, rigid muscles, unusual body movements, and confusion. Your doctor will probably need to decrease your dose of opicapone slowly and change the doses of your other medications for Parkinson's disease.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking opicapone,

• tell your doctor and pharmacist if you are allergic to opicapone, any other medications, or any of the ingredients in opicapone capusules. Ask your pharmacist for a list of the ingredients.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil) or tranylcypromine (Parnate)..
• some medications should not be taken with opicapone. Other medications may cause dosing changes or extra monitoring when taken with opicapone. Make sure you have discussed any medications you are currently taking or plan to take before starting opicapone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking opicapone, please get the advice of your doctor or pharmacist.
• tell your doctor if you have pheochromocytoma or paraganglioma (tumors on or around a small gland near the kidneys). Your doctor will probably tell you not to take opicapone.
• tell your doctor if you have or have ever had unexpected daytime sleepiness or a sleep disorder, dyskinesia (uncontrolled sudden movements), a psychotic disorder (mental illness that causes abnormal thinking or perceptions), or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking opicapone, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking opicapone.
• you should know that opicapone may make you drowsy or may cause you to suddenly fall asleep during your regular daily activities. You might not feel drowsy or have any other warning signs before you suddenly fall asleep. Do not drive a car, operate machinery, work at heights, or participate in potentially dangerous activities at the beginning of your treatment until you know how the medication affects you. If you suddenly fall asleep while you are doing something such as watching television, talking, eating, or riding in a car, or if you become very drowsy, especially during the daytime, call your doctor. Do not drive, work in high places, or operate machinery until you talk to your doctor.
• remember that alcohol can add to the drowsiness caused by this medication. Tell your doctor if you regularly drink alcoholic drinks.
• you should know that some people who took medications such as opicapone developed new or increased gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have an urge to gamble that is difficult to control, you have intense urges, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem.
• you should know that opicapone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking opicapone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

You should skip the missed dose. Take your regular dose at your next bedtime. Do not double the next dose to make up for the missed dose.

What SIDE EFFECTS can this medicine cause?

Opicapone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• dry mouth
• difficulty falling asleep or staying asleep
• dizziness
• weight loss
• unusual or uncontrolled body movements

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• hallucinations (seeing things or hearing voices that do not exist)
• delusions (having strange thoughts or beliefs that have no basis in reality)
• aggressive behavior
• fainting

Opicapone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2020.