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NUPLAZID® (pimavanserin) logo - once daily - 34 mg capsules
NUPLAZID® (pimavanserin) logo - once daily - 34 mg capsules NUPLAZID® (pimavanserin) logo - once daily - 34 mg capsules

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From when you first discuss Parkinson’s disease (PD) psychosis, to how you choose to treat it—

EVERY MOVE MATTERS

Choose NUPLAZID as your first-line prescription for hallucinations and delusions associated with PD psychosis.

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Symptoms of PD psychosis can get worse over time1,2

  • Hallucinations with insight can progress to hallucinations without insight and delusions
  • Because patients commonly do not disclose their nonmotor symptoms, screening early for hallucinations and delusions may help identify psychosis earlier

See how symptoms impact daily life

NUPLAZID significantly reduced the frequency and/or severity of hallucinations and delusions associated with PD psychosis without impacting motor function3,4

  • Primary efficacy was evaluated based on change from baseline to Week 6 in SAPS-PD total score (n=95 NUPLAZID; n=90)
  • A key secondary endpoint was motor function change from baseline to Week 6 in UPDRS Parts II+III

SAPS-PD=Scale for the Assessment of Positive Symptoms adapted for Parkinson’s disease; UPDRS Parts II+III=Unified Parkinson’s Disease Rating Scale Parts II and III.

Learn about the proven efficacy of NUPLAZID

NUPLAZID has a demonstrated safety profile in patients with PD psychosis3,5

  • The common 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%)
  • Selected nonmotor adverse reactions included sedation-related events (6.4% NUPLAZID vs 5.2% placebo) and orthostatic hypotension–related events (6.9% NUPLAZID vs 10.4% placebo)
    • Sedation-related events included sedation, somnolence, fatigue, asthenia, lethargy, and hypersomnia
    • Orthostatic hypotension–related events included dizziness, hypotension, orthostatic hypotension, orthostatic intolerance, syncope, vertigo positional, postural orthostatic tachycardia syndrome, and vertigo.

Important Safety Information

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-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.

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.

Warnings and Precautions: QT Interval Prolongation

  • 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 including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.

  • 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.

Drug Interactions:

  • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.

  • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

See the full safety profile
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About PD Psychosis

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-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
  • 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.

  • Warnings and Precautions: QT Interval Prolongation

    • 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 including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.

    • 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.

  • Adverse Reactions: The common 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%).

  • Drug Interactions:

    • Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.

    • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

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.

NUPLAZID is available as 34 mg capsules and 10 mg tablets.

Please read the full Prescribing Information, including Boxed WARNING.

References:
  1. Goetz CG, Fan W, Leurgans S, Bernard B, Stebbins GT. The malignant course of “benign hallucinations” in Parkinson disease. Arch Neurol. 2006;63(5):713-716.
  2. Chaudhuri KR, Prieto-Jurcynska C, Naidu Y, et al. The nondeclaration of nonmotor symptoms of Parkinson’s disease to health care professionals: an international study using the nonmotor symptoms questionnaire. Mov Disord. 2010;25(6):704-709.
  3. Acadia Pharmaceuticals Inc. NUPLAZID® [package insert]. San Diego, CA; 2020.
  4. Cummings J, Isaacson S, Mills R, et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014;383(9916):533-540.
  5. 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. https://www.fda.gov/media/96755/download. Accessed March 7, 2022.

Safety & Tolerability