Pimavanserin

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and may cause changes in mood and personality) who take antipsychotics (medications for mental illness) have an increased risk of death during treatment. Pimavanserin is not approved for the treatment of people with dementia-related psychosis that are not related to the hallucinations and delusions from Parkinson's disease.

Pimavanserin is used to treat hallucinations and delusions in people with psychosis from Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Pimavanserin is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Pimavanserin comes as a tablet and capsule to take by mouth. It is usually taken once daily with or without food. Take pimavanserin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pimavanserin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole, or open the capsule and sprinkle the contents on a small amount (one tablespoon) of applesauce, yogurt, pudding, or a liquid nutritional supplement. Eat or drink the entire mixture immediately without chewing. Do not store the mixture for future use.

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

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

Before taking pimavanserin,

• tell your doctor and pharmacist if you are allergic to pimavanserin, any other medications, or any of the ingredients in pimavanserin tablets and capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with pimavanserin: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking pimavanserin. Do not start any of these medications while taking pimavanserin without discussing with your healthcare provider
• tell your doctor if you or anyone in your family has or has ever had QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death); a slow or irregular heartbeat; low levels of potassium or magnesium in your blood; or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking pimavanserin, call your doctor.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• nausea
• constipation
• swelling of hands, ankles, or feet
• sleepiness

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)
• confusion
• difficulty walking normally
• rash
• hives
• swelling of the face, eyes, eyelids, lips, or tongue
• throat tightness
• shortness of breath

Pimavanserin 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).

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 excess heat and moisture (not in the bathroom). Protect the capsules from light.

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.

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.

Symptoms of overdose may include:

• nausea
• vomiting
• irregular heartbeat

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.

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