Pimavanserin

Pimavanserin is a medicine for mental health that changes how chemicals in the brain act.

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

Pimavanserin may also be used for other reasons that are not mentioned in this medication guide.

Follow all instructions 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 over a spoonful of applesauce, yogurt, pudding, or a liquid nutritional supplement. 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 change your pimavanserin dose.

Store at room temperature away from moisture, heat, and light.

Pimavanserin is not approved for use in older adults who have psychosis related to dementia.

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 or have ever had:

• a heart rhythm disorder or long QT syndrome (in you or a family member);
• slow heartbeats that have caused you to faint;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• kidney disease.

It is not known if pimavanserin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using pimavanserin.

Not approved for use by anyone younger than 18 years old.

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

Pimavanserin may cause serious side effects. Contact your doctor immediately if you experience:

• fast or pounding heartbeats, fluttering in your chest;
• shortness of breath; or
• sudden dizziness (like you might faint).

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 happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Psychosis:

34 mg (as two 17 mg tablets) orally once a dayComment: This drug does not require titration.Use: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

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

• Overdose may cause nausea and vomiting.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, 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 inform your doctor if you start or stop using any other medications.

Pimavanserin can affect your heart rhythm. Your risk may be higher if you use some medicines for infections, heart problems, high blood pressure, mental illness, or cancer that can also affect your heart rhythm, or if you have certain heart problems, low potassium, or low magnesium in your blood.

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