Once-Daily NUPLAZID® (pimavanserin) 34 mg Capsule

The Safety Story:

See the results of 6-week placebo-controlled studies1

Once-Daily NUPLAZID® (pimavanserin) 34 mg Capsule

In the 6-week studies, 80% of patients were aged 65 years or older1

NUPLAZID 34 mg-Demonstrated Safety Profile Proven in Elderly Patients with PD Psychosis
  • In the 6-week studies, 80% of patients in NUPLAZID clinical studies were aged 65 years or older*
  • No differences in safety were reported based on age, gender, or MMSE score - 27% of patients had mild cognitive impairment (MMSE 21-24)
  • 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%)

Important Safety Information for NUPLAZID (pimavanserin)

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

*The maximum age in the clinical studies was 90 years.2
MMSE=Mini-Mental State Examination.

Safety profile demonstrated in placebo-controlled studies1

NUPLAZID® (pimavanserin) Adverse Reactions, ChartNUPLAZID® (pimavanserin) Adverse Reactions, Chart

*Based on 6-week placebo-controlled studies.

A demonstrated safety profile in elderly patients with Parkinson’s disease (PD) psychosis1

In the 6-week placebo-controlled trials:

No Adverse Events Reported of NMS in 6 week Trials, Icon
  • No events of neuroleptic malignant syndrome, tardive dyskinesia, or serotonin syndrome were reported with NUPLAZID® (pimavanserin) 34 mg2,3
8% of NUPLAZID® (pimavanserin) 34mg Patients Discontinued Due to Adverse Reactions, Icon
  • 8% (n=202) of patients treated with NUPLAZID 34 mg discontinued due to adverse reactions vs 4% (n=231) with placebo1
    - 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)
Fewer Cases of Orthostatic Hypotension Reported Compared with Placebo, Icon
  • Fewer cases of orthostatic hypotension were reported for NUPLAZID 34 mg compared with placebo (1.0% vs 5.2%)2

In September 2018, FDA issued a statement on the benefit-risk profile of NUPLAZID.4 Read the entire statement at FDA.gov

FDA=Food and Drug Administration.

Important Safety Information for NUPLAZID (pimavanserin)

  • 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.
For healthcare professionals