Pimavanserin

What is Pimavanserin?

• Pimavanserin (Nuplazid) is an atypical antipsychotic used for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

What are the uses of this medicine?

• This medicine is used for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

How does this medicine work?

• The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinson's disease psychosis is unclear. However, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of a hypersensitivity reaction to pimavanserin or any of its components.

What drug interactions can this medicine cause?

• Avoid the use of Nuplazid in combination with other drugs known to prolong QT interval (eg: Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; Antibiotics: gatifloxacin, moxifloxacin).
• If Nuplazid is used with a strong CYP3A4 inhibitor (eg: itraconazole, ketoconazole, clarithromycin, indinavir), reduce the dosage of Nuplazid.
• Avoid concomitant use of strong or moderate CYP3A4 inducers (Strong inducers: carbamazepine, St. John's wort, phenytoin, rifampin; Moderate inducers: modafinil, thioridazine, efavirenz, nafcillin) with Nuplazid

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

Recommended Dosage:

• The recommended dose of Nuplazid is 34 mg taken orally once daily, without titration.

Coadministration with Strong CYP3A4 Inhibitors

• The recommended dose of Nuplazid when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole) is 10 mg, taken orally as one tablet once daily.

Administration

• Nuplazid can be taken with or without food.
• Nuplazid capsules can be taken whole, or opened and the entire contents sprinkled over a tablespoon (15 mL) of applesauce, yogurt, pudding, or a liquid nutritional supplement. Consume the drug/food mixture immediately without chewing; do not store for future use.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 34 mg
• Tablets: 10 mg

This medicine is available in fallowing brand namesː

• Nuplazid

What side effects can this medication cause?

The most common side effects of this medicine include:

• peripheral edema
• confusional state

What special precautions should I follow?

• Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis. Nuplazid is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
• Nuplazid prolongs the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval.

What to do in case of emergency/overdose?

• Symptoms related to overdosage are nausea and vomiting .

Management for overdosage:

• There are no known specific antidotes for Nuplazid.
• In managing overdose, cardiovascular monitoring should commence immediately and should include continuous ECG monitoring to detect possible arrhythmias .
• If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine should not be used, as they have the potential for QT-prolonging effects that might be additive to those of Nuplazid.

Can this medicine be used in pregnancy?

• There are no data on Nuplazid use in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness of Nuplazid have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Pimavanserin tartrate capsule

• Active ingredient:

pimavanserin tartrate

• Inactive ingredients:

magnesium stearate MICROCRYSTALLINE CELLULOSE HYPROMELLOSE titanium dioxide FERRIC OXIDE YELLOW FD&C BLUE NO. 1 FERROSOFERRIC OXIDE

pimavanserin tartrate tablet, coated

• Active ingredient:

pimavanserin tartrate

• Inactive ingredients:

starch, corn magnesium stearate MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL 1000 talc titanium dioxide FERRIC OXIDE YELLOW FERRIC OXIDE RED

Who manufactures and distributes this medicine?

• Distributed by:

Acadia Pharmaceuticals Inc. San Diego Nuplazid® is a trademark of Acadia Pharmaceuticals Inc.

What should I know about storage and disposal of this medication?

34 mg Capsule:

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
• To prevent potential capsule color fading, protect from light.

10 mg Tablet:

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

• Dailymed label info on Pimavanserin
• FDA Pimavanserin

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