Pimavanserin is an antipsychotic medicine that works by changing the actions of chemicals in the brain.

Pimavanserin is used to treat hallucinations and delusions caused by psychosis that is related to Parkinson's disease.

Pimavanserin may also be used for purposes not listed in this medication guide.

Pimavanserin is not approved for use in older adults with dementia-related psychosis.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take pimavanserin with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of pudding, applesauce, yogurt, or a nutrition drink. Swallow the mixture right away without chewing. Do not save it for later use.

When you start or stop taking other medicines, your doctor may need to adjust your pimavanserin dose.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Psychosis:

34 mg (as two 17 mg tablets) orally once a day

Comment: This drug does not require titration.

Use: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pimavanserin may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

You should not use pimavanserin if you are allergic to it.

Tell your doctor if you have ever had:

• a heart rhythm disorder;

• long QT syndrome (in you or a family member);

• kidney disease; or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Tell your doctor if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause nausea and vomiting.

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).

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Avoid drinking alcohol. Dangerous side effects could occur.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Pimavanserin may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest;

• shortness of breath; or

• sudden dizziness (like you might pass out).

Common side effects of pimavanserin may include:

• confusion; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Your pimavanserin dose may need to be adjusted if you use certain other medications. It is very important to tell your doctor if you start or stop using any other medications.

Pimavanserin can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect pimavanserin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.