Pimavanserin (Nuplazid)

Brand Names:

Nuplazid

  • Tablets: 17 mg

Generic name: Pimavanserin

All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.

What Is Pimavanserin™ And What Does It Treat?

Pimavanserin is a medication that works in the brain to treat hallucinations and delusions associated with Parkinson’s disease psychosis. It is also known as aselective serotonin inverse agonist. The exact mechanism in which Pimavanserin works to help with Parkinson’s disease psychosis is unknown but thought to help with psychosis by blocking certain serotonin receptors.

Symptoms of Parkinson’s disease psychosis include:

  • Delusions-beliefs that are not true (e.g. other people are reading your thoughts)
  • Hallucinations- imagined voices or images that seem real

Pimavanserin may help with some or all of these symptoms.

What Is The Most Important Information I Should Know About Pimavanserin?

A person with Parkinson’s disease may begin to have delusions or hallucinations. These symptoms may continue to occur throughout the illness. Do not stop taking pimavanserin, even when you feel better.

Only your healthcare provider can determine the length of pimavanserin treatment that is right for you.

Missing doses of pimavanserin may increase your risk for a relapse in your symptoms.

Do not change your dose of pimavanserin without talking to your healthcare provider.

For pimavanserin to work properly, it should be taken every day as prescribed by your healthcare provider.

Are There Specific Concerns About Pimavanserin And Pregnancy?

Pregnancy is uncommon in people with Parkinson’s disease.  There is no information on pimavanserin’s use in pregnant women that would help predict the risk of serious side effects to an unborn child.  If you are planning on becoming pregnant, notify your healthcare provider to best manage your medications.  It is important to discuss the risks and benefits of treatment with your doctor and caregivers.

There is no information regarding pimavanserin in lactation, therefore, caution should be advised when breast-feeding.

What Should I Discuss With My Healthcare Provider Before Taking Pimavanserin?

  • Symptoms of your condition that bother you the most.
  • If you have thoughts of suicide or harming yourself
  • Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects.
  •  All other medications you are currently taking (including over-the-counter products, herbals, and nutritional supplements) and any medication allergies you may have
  • If you experience side effects from your medications, discuss them with your provider.
  • Some side effects may pass with time, but others may require adjustments in the medication.
  • Any psychiatric or medical problems you have, such as heart rhythm problems, long QT syndrome (irregular heart beat), or heart attacks
  • If you are pregnant, plan to become pregnant, or are breast-feeding
  • If you smoke, drink alcohol, or use illegal drugs.
  • If you have liver disease or kidney disease.

How Should I Take Pimavanserin?

The recommended dose for pimavanserin is 34 mg, usually taken as two 17mg tablets, once daily with or without food.

Use a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member or a friend to remind you or check in with you to be sure you are taking your medication.

What Happens If I Miss A Dose Of Pimavanserin?

If you miss a dose of pimavanserin, take it as soon as you remember, unless it is closer to the time of your next dose.

If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

Do not double your dose (e.g. take more than 34 mg total) or take more than prescribed.

What Should I Avoid While Taking Pimavanserin?

Avoid drinking alcohol or using illegal drugs while you are taking pimavanserin. They may decrease the benefits (worsen your confusion) and increase adverse effects (sedation, nausea) of the medication.

What Happens If I Overdose With Pimavanserin?

If an overdose occurs call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

A specific treatment to reverse the effects of pimavanserin does not exist.

What Are Possible Side Effects Of Pimavanserin?

Common Side Effects

Peripheral edema, confusion, abnormal gait, hallucination, nausea, constipation

Rare Side Effects

Urinary tract infections, Fatigue

Serious Side Effects

Patients who take pimavanserin may be at risk for a certain type of arrhythmia (irregular heart beat). To lower this risk, this medication should be used in the smallest effective dose when the benefits outweigh the risks.  Your doctor may order an EKG to monitor for irregular heart beat.

Allergic reaction is a risk to any component of pimavanserin. The patient should watch for signs of an allergic reaction such as wheezing, chest tightness, itching, swelling of face or lips.

Are There Any Risks For Taking Pimavanserin For Long Periods Of Time?

None have been reported at this time.

What other medications may interact with pimavanserin?

The following medications may increase the risk of an arrhythmia (irregular heart beat) when taken with pimavanserin:

  • Antipsychotics, including chlorpromazine (Thorazine), thioridizine (Mellaril), asenapine (Saphris), iloperidone (Fanapt), paliperidone (Invega), and quetiapine (Seroquel)
  • Antiarrhythmics (heart rhythm medications), including procainamide, quinidine, amiodarone (Cordarone), dronedarone (Multaq), and sotalol (Betapace)
  • Antibiotics, including moxifloxacin

The following medications may increase the levels and the effects of pimavanserin:

  • Itraconazole, Ketoconazole, Clarithromycin, Indinavir

The following medications may decrease the levels and the effects of pimavanserin:

  • Rifampin, Carbamazepine, Phenytoin, St, Johns Wort

How Long Does It Take For Pimavanserin To Work?

It is very important to tell your doctor how you feel things are going during the first few weeks after you start taking pimavanserin. It may take several days to see symptoms improve after you start pimavanserin. It may take up to 2 weeks to see significant changes in symptoms.

  • Hallucinations  and delusions may improve in the first 1-2 weeks
  • Sometimes these symptoms do not completely go away
  • Symptoms will continue to get better the longer you take pimavanserin.
  • It may take a couple of months before feeling the full benefit of pimavanserin.

Provided by

College of Psychiatric and Neurologic Pharmacists

November 2016

Summary of FDA Black Box Warnings

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

  • Similar medications,  first generation (typical) and second generation (atypical) antipsychotics, are associated with an increased risk of mortality in elderly patients when used for dementia related psychosis.
  • Although there were multiple causes of death in studies, most deaths appeared to be due to cardiovascular causes (e.g. sudden cardiac death) or infection (e.g. pneumonia)
  • Nuplazid (pimavanserin) is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.