NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

NUPLAZID Safety Data

NUPLAZID has a demonstrated safety profile in patients with PD psychosis1,2

Adverse drug reactions reported in ≥2% and greater than placebo in 6-week
placebo-controlled studies1

Chart shows adverse reactions for patients with NUPLAZID® treatment vs placebo in placebo-controlled 6-week treatment studies
Chart shows adverse reactions for patients with NUPLAZID® treatment vs placebo in placebo-controlled 6-week treatment studies

No differences in safety were reported based on age, gender, or MMSE score
(MMSE 21-24 vs ≥25)1

  • 80% of patients on NUPLAZID were aged 65 years or older (Maximum age on NUPLAZID vs placebo was 85 and 90, respectively)1
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.

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.

Low rates of discontinuation due to adverse reactions

8% (n=16) of patients treated with NUPLAZID discontinued due to adverse reactions vs 4% (n=10) with placebo.1

  • The adverse reactions that occurred in more than one patient and with an incidence of at least twice that of placebo were hallucination (2% NUPLAZID vs <1% placebo), urinary tract infection (1% NUPLAZID vs <1% placebo), and fatigue (1% NUPLAZID vs 0% placebo)

Sedation-related and orthostatic hypotension–related events in 6-week placebo-controlled studies2

Chart shows selected nonmotor adverse events
Chart shows selected nonmotor adverse events
  • There are no warnings or precautions in the Prescribing Information for sedation or orthostatic hypotension1

  • Sedation-related events included sedation, somnolence, fatigue, asthenia, lethargy, and hypersomnia2

  • Orthostatic hypotension–related events included dizziness, hypotension, orthostatic hypotension, orthostatic intolerance, syncope, vertigo positional, postural orthostatic tachycardia syndrome, and vertigo2

Important Safety Information

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.

Long-term safety findings from an open-label safety study

More than half of enrolled patients remained in the open-label safety extension study for 1 year3,4

Kaplan-Meier graph shows percentages of NUPLAZID® patients on treatment over 48 months
Kaplan-Meier graph shows percentages of NUPLAZID® patients on treatment over 48 months

No new or unexpected safety findings were observed in patients receiving NUPLAZID in an OLE study3

Patient discontinuation and treatment-emergent adverse events in open-label extension safety study over 9 years of study follow-up

Termination reason recorded in ≥10% of patients (N=459)3†
Primary reason Overall, n (%)
Voluntary withdrawal of consent 167 (36.4)
Adverse event 88 (19.2)
Sponsor decision 55 (12.0)
Disease progression 46 (10.0)

Other reasons for termination (<10%) included death (n=34), investigator decision, subject non-compliance, and lost to follow-up.

Over 9 years of study follow-up, the total number of all-cause deaths was 59 patients. The deaths occurred during treatment or within 30 days after the last dose of NUPLAZID.

The types of adverse events reported in an OLE study were comparable to the 6-week placebo-controlled studies3

Treatment-emergent adverse events occurring in ≥10% of patients (N=459)3
Adverse event Number (%) of patients
Fall 147 (32.0)
Urinary tract infection 87 (19.0)
Hallucination 63 (13.7)
Weight decreased 57 (12.4)
Confusional state 51 (11.1)
Constipation 47 (10.2)

Important note: The results of this OLE safety study should be interpreted with the following limitations: open-label design, lack of control arm, inability to assess patients long-term after discontinuation, and high discontinuation rate due to various reasons over >4 years of the study duration. This could represent chance findings.

Safety & Tolerability

Adverse drug reactions reported in ≥2% and greater than placebo in 6-week
placebo-controlled studies1

Illustration showing NUPLAZID® safety profile in elderly patients with PD psychosis
Illustration showing NUPLAZID® safety profile in elderly patients with PD psychosis

No differences in safety were reported based on age, gender, or MMSE score
(MMSE 21-24 vs ≥25)1

  • 80% of patients on NUPLAZID were aged 65 years or older (maximum age on NUPLAZID vs placebo was 85 and 90, respectively)1
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.

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.

Low rates of discontinuation due to adverse reactions

8% (n=16) of patients treated with NUPLAZID discontinued due to adverse reactions vs 4% (n=10) with placebo.1

  • The adverse reactions that occurred in more than one patient and with an incidence of at least twice that of placebo were hallucination (2% NUPLAZID vs <1% placebo), urinary tract infection (1% NUPLAZID vs <1% placebo), and fatigue (1% NUPLAZID vs 0% placebo)

Sedation-related and orthostatic hypotension–related events in 6-week placebo-controlled studies2

Chart shows selected nonmotor adverse events
Chart shows selected nonmotor adverse events
  • There are no warnings or precautions in the Prescribing Information for sedation or orthostatic hypotension1

  • Sedation-related events included sedation, somnolence, fatigue, asthenia, lethargy, and hypersomnia2

  • Orthostatic hypotension–related events included dizziness, hypotension, orthostatic hypotension, orthostatic intolerance, syncope, vertigo positional, postural orthostatic tachycardia syndrome, and vertigo2

Important Safety Information

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.

Long-term safety findings from an open-label safety study

More than half of enrolled patients remained in the open-label safety extension study for 1 year3,4

Kaplan-Meier graph shows percentages of NUPLAZID® patients on treatment over 48 months
Kaplan-Meier graph shows percentages of NUPLAZID® patients on treatment over 48 months

No new or unexpected safety findings were observed in patients receiving NUPLAZID in an OLE study3

Patient discontinuation and treatment-emergent adverse events in open-label extension safety study over 9 years of study follow-up

Termination reason recorded in ≥10% of patients (N=459)3†
Primary reason Overall, n (%)
Voluntary withdrawal of consent 167 (36.4)
Adverse event 88 (19.2)
Sponsor decision 55 (12.0)
Disease progression 46 (10.0)

Other reasons for termination (<10%) included death (n=34), investigator decision, subject non-compliance, and lost to follow-up.

Over 9 years of study follow-up, the total number of all-cause deaths was 59 patients. The deaths occurred during treatment or within 30 days after the last dose of NUPLAZID.

The types of adverse events reported in an OLE study were comparable to the 6-week placebo-controlled studies3

Treatment-emergent adverse events occurring in ≥10% of patients (N=459)3
Adverse event Number (%) of patients
Fall 147 (32.0)
Urinary tract infection 87 (19.0)
Hallucination 63 (13.7)
Weight decreased 57 (12.4)
Confusional state 51 (11.1)
Constipation 47 (10.2)

Important note: The results of this OLE safety study should be interpreted with the following limitations: open-label design, lack of control arm, inability to assess patients long-term after discontinuation, and high discontinuation rate due to various reasons over >4 years of the study duration. This could represent chance findings.

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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. Acadia Pharmaceuticals Inc. NUPLAZID® [package insert]. San Diego, CA; 2020.
  2. 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 February 23, 2022.
  3. Ballard CG, Kreitzman DL, Isaacson S, et al. Long-term evaluation of open-label pimavanserin safety and tolerability in Parkinson’s disease psychosis. Parkinsonism Relat Disord. 2020;77:100-106.
  4. Data on File (015), Acadia Pharmaceuticals Inc.