NUPLAZID may not be right for everyone. If you have any questions about this medication or this safety information, be sure to discuss with your healthcare provider.

What is the most important information I should know about NUPLAZID?

• Medicines like NUPLAZID can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
• NUPLAZID is not approved for the treatment of patients with dementia who experience psychosis unless their hallucinations and delusions are related to Parkinson's disease.

Who should not take NUPLAZID?

Do not take NUPLAZID if you are allergic to pimavanserin or any of the other ingredients in NUPLAZID. Get emergency medical help if you are having an allergic reaction. Symptoms may include:

• rash
• hives
• throat tightness
• shortness of breath
• swelling of your tongue, mouth, lips, or face

NUPLAZID may increase the risk of certain changes to your heart rhythm. Therefore, do not take NUPLAZID if:

• You have certain heart conditions that change your heart rhythm, or
  • known QT prolongation as measured on an ECG (a device that traces electrical activity of the heart)
  • a history of certain irregularities of heart rhythm (discuss the specifics with your doctor)
• You are currently taking medicines that are known to prolong the QT interval. Ask your healthcare provider if you are not sure if you are taking any of these medicines. Examples include:
  • some medicines used to treat abnormal heart rhythms (for example, quinidine, procainamide, amiodarone, sotalol)
  • some antipsychotic medications (for example, ziprasidone, chlorpromazine, thioridazine)
  • some antibiotics (for example, gatifloxacin, moxifloxacin)

Call your healthcare provider if you feel any symptoms of heart arrhythmia (for example, fluttering in chest, racing or slow heartbeat, chest pain, shortness of breath, lightheadedness or dizziness, or fainting).

What should I tell my healthcare provider before taking NUPLAZID?

Before taking NUPLAZID, tell your healthcare provider if you:

• have heart problems
• take medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
• are pregnant or plan to become pregnant. It is not known if NUPLAZID may harm your unborn baby.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take NUPLAZID?

• Take NUPLAZID exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking NUPLAZID without talking to your healthcare provider first.
• The recommended dose is one 34 mg capsule, once per day, taken by mouth.
• NUPLAZID can be taken with or without food.

What are the possible side effects of NUPLAZID?

Common side effects include:

• swelling in the legs or arms
• nausea
• feeling confused
• hallucinations
• constipation
• changes to normal walking

These are not all the possible side effects of NUPLAZID.

General Information about NUPLAZID

This is a brief summary of risk and safety information for patients about NUPLAZID. This information is not comprehensive and does not take the place of talking to your doctor about your treatment. To learn more, talk about NUPLAZID with your healthcare provider.