PIMAVANSERIN TAB
Clinical Criteria Summary
Exclusion Criteria
- Diagnosis of dementia-related psychosis due to Alzheimer’s disease, Lewy Body Dementia or other dementia not secondary to Parkinson disease
- Known QTc prolongation, history of cardiac arrhythmias, or circumstances increasing risk of torsade de pointes and/or sudden death (including symptomatic bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval)
- Taking other medications known to prolong the QT interval
- Taking another antipsychotic
- Taking a moderate or strong CYP3A4 inducer
Inclusion Criteria
- Meets diagnostic criteria for Parkinson Disease Psychosis (PDP):
- Presence of at least one PDP symptom: illusions, false sense of presence, hallucinations or delusions
- Primary diagnosis of Parkinson disease (PD)
- PDP symptoms occur after the onset of PD
- Duration of PDP symptoms is recurrent or continuous for 1 month
- Symptoms are not better accounted for by another cause (e.g., dementia with Lewy bodies, psychiatric disorders such as schizophrenia/schizoaffective disorder/delusional disorder/mood disorder with psychotic features, or a general medical condition including delirium)
- Prescriber is a psychiatrist, neurologist or geriatric medicine specialist
Renewal Criteria
- Assess effectiveness within 3 months after initiation via in-person or telephone interview with the patient and/or caregiver
- Discontinue if ineffective
Dosage & Administration
- Recommended dose: 34 mg, taken orally once daily, without titration
- Can be taken with or without food
- When coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole), recommended dose is 10 mg, taken orally as one tablet once daily
Clinical Considerations & Warnings
- Indicated for treatment of hallucinations and delusions associated with Parkinson disease psychosis
- Box Warning: Increased mortality in elderly patients with dementia-related psychosis; not approved for dementia-related psychosis unrelated to PD psychosis
- Avoid combination with another antipsychotic due to increased mortality rate and serious adverse events; discontinue current antipsychotics before starting pimavanserin
- Prolongs the QT interval; avoid in patients with known QT prolongation, history of cardiac arrhythmias, or those taking drugs that prolong QT (including Class 1A/3A antiarrhythmics, certain antipsychotics, and certain antibiotics)
- Failed to demonstrate efficacy as an augmentation treatment for schizophrenia