Confidently prescribe NUPLAZID® (pimavanserin), a single once-daily capsule, for appropriate patients with hallucinations and delusions associated with Parkinson’s disease (PD) psychosis.1
NUPLAZID Dosing
Once-daily dose, no titration needed1
- 34 mg taken orally, once daily
- Taken with or without food
- Taken whole or sprinkled
(Not actual size)* *Actual size is 14.4 mm x 5.3 mm
The NUPLAZID 34 mg capsule can be opened, and the entire contents sprinkled over a tablespoon (15 mL) of applesauce, yogurt, pudding, or a liquid nutritional supplement. The drug/food mixture should be consumed immediately without chewing; do not store for future use.
Dosing considerations1,2
- For patients taking strong CYP3A4 inhibitors, the recommended dose of NUPLAZID is one 10 mg tablet once daily
- Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID
- Avoid the use of NUPLAZID in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval†
- NUPLAZID does not require a dosage adjustment in elderly patients, in patients with mild to severe renal impairment or end-stage renal disease (ESRD),‡ or in patients with hepatic impairment
- The steady-state plasma concentration of NUPLAZID was reached in ~12 days with continuous treatment, without titration
- Half-life(t1/2) is 57 hours
- No dosage adjustment of carbidopa/levodopa is required when administered concomitantly with NUPLAZID
†In the 6-week placebo-controlled Parkinson’s disease psychosis studies, NUPLAZID prolonged the QT interval (mean increase ~5-8 ms).
‡Increased exposure (Cmax and AUC) to NUPLAZID occurred in patients with severe renal impairment (CrCl <30 mL/min, Cockcroft-Gault) in a renal impairment study. NUPLAZID should be used with caution in patients with severe renal impairment and ESRD.
Gradual dose reduction may not be necessary in long-term care3
Per Centers for Medicare & Medicaid Services (CMS) guidelines, gradual dose reduction (GDR) may be clinically contraindicated for psychotropic medications used to treat enduring and progressive conditions such as PD psychosis.
F758 in the CMS State Operations Manual for long-term care facilities outlines the requirements for appropriate use of psychotropic medications in nursing facilities, including patient monitoring, documentation of symptoms, and GDR. CMS specifically notes the following:
- Residents with specific progressive and enduring conditions (such as PD psychosis) may need psychotropic medications indefinitely
- GDR of a psychotropic medication may be clinically contraindicated if continued use is in accordance with relevant current standards and the physician has documented that a GDR is not appropriate
Download the Getting Started on NUPLAZID brochure for information on Acadia Connect®, prescribing NUPLAZID, and more.
Order samples of NUPLAZID for your patients.
IMPORTANT SAFETY INFORMATION and INDICATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
- 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.
- Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
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Warnings and Precautions: QT Interval Prolongation
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NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval (e.g., Class 1A antiarrhythmics, Class 3 antiarrhythmics, certain antipsychotics or antibiotics).
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NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
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- Adverse Reactions: The adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
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Drug Interactions:
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Coadministration with strong CYP3A4 inhibitors increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
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Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.
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Indication NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Dosage and Administration Recommended dose: 34 mg capsule taken orally once daily, without titration, with or without food.
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please read the full Prescribing Information, including Boxed WARNING.
References:
- Acadia Pharmaceuticals Inc. NUPLAZID® [package insert]. San Diego, CA; 2023.
- Acadia Pharmaceuticals Inc. NUPLAZID Advisory Committee Briefing Document. San Diego, CA: Sponsor Background Information for a Meeting of the Psychopharmacologic Drugs Advisory Committee; March 29, 2016.
- Centers for Medicare & Medicaid Services. State Operations Manual Pub. 100-07. Appendix PP–Guidance to surveyors for long term care facilities. Baltimore, MD: US Dept of Health and Human Services; 2023.