NUPLAZID safety & tolerability

Improve PD psychosis without slowing down your patients1

NUPLAZID did not affect motor function or motoric activities of daily living1,2

  • Unified Parkinson’s Disease Rating Scale (UPDRS) II+III is a clinical rating scale that assesses motor function and its impact on activities of daily living1

*Difference (drug minus placebo) in least-squares mean (LSM).

Noninferiority criteria required that the upper bound of the 95% CI not exceed 5.

CI=confidence interval.

Keep patients with PD psychosis living on their own terms1*

NUPLAZID® (pimavanserin) did not impact motor function or inhibit motoric activities of daily living compared to placebo per UPDRS II+III1,3,4
  • Speech
  • Salivation
  • Swallowing
  • Handwriting
  • Cutting food and handling utensils
  • Dressing
  • Hygiene
  • Turning in bed and adjusting bed clothes
  • Falling (unrelated to freezing)
  • Freezing when walking
  • Walking
  • Tremor
  • Sensory complaints related to Parkinsonism
  • Speech
  • Facial expression
  • Tremor at rest
  • Action or postural tremor of hands
  • Rigidity
  • Finger taps
  • Hand movements
  • Rapid alternating movements of hands
  • Foot agility
  • Arising from chair
  • Posture
  • Gait
  • Postural stability
  • Body bradykinesia and hypokinesia

*As measured by UPDRS II+III.

Incidence of adverse events (AEs) was consistent in patients >75 years old vs ≤75 years old1

Adverse reactions reported in ≥2% and greater than placebo*

  • Discontinuation rates due to adverse reactions were low1*
    • 8% with NUPLAZID vs 4% with placebo
  • No events of neuroleptic malignant syndrome or tardive dyskinesia were reported with NUPLAZID in placebo-controlled clinical trials3
  • Fewer cases of orthostatic hypotension were reported for NUPLAZID 34 mg compared with placebo (1.0% vs 5.2%) in controlled clinical trials3

*Based on 6-week placebo-controlled studies.

NUPLAZID 34 mg has a proven safety profile in elderly patients1

In the 6-week studies, 49% of patients on NUPLAZID were 65 to 75 years old and 31% were >75 years old1

  • 27% had mild cognitive impairment (MMSE 21-24)1
  • The maximum age in the clinical trials was 90 years old3

MMSE=Mini-Mental Status Examination.

Important Safety Information for NUPLAZID (pimavanserin) 17-mg Tablets

Important Safety Information for NUPLAZID (pimavanserin) 17-mg Tablets

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.

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 most 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: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration

Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.

Indication

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

To report SUSPECTED ADVERSE REACTIONS, contact ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342) or FDA at www.fda.gov/medwatch , or call 1-800-FDA-1088.

Please read the full Prescribing Information including Boxed WARNING.

This website is intended for use by US residents.

Important Safety Information for NUPLAZID (pimavanserin) 17-mg Tablets

Important Safety Information for NUPLAZID (pimavanserin) 17-mg Tablets

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.

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 most 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: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration

Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.

Indication

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

To report SUSPECTED ADVERSE REACTIONS, contact ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342) or FDA at www.fda.gov/medwatch , or call 1-800-FDA-1088.

Please read the full Prescribing Information including Boxed WARNING.

This website is intended for use by US residents.

References:

  1. NUPLAZID® (pimavanserin) prescribing information, ACADIA.
  2. 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.
  3. Data on file, ACADIA.
  4. Fahn S, Elton R, Members of the UPDRS Development Committee. Unified Parkinson’s Disease Rating Scale. In: Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent Developments in Parkinson’s Disease, vol 2. Florham Park, NJ: Macmillan Health Care Information; 1987:153-163, 293-304.