Transcript
[Slide]
Indication
NUPLAZID® (primavanserin) is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
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 who experience psychosis unless their hallucinations and delusions are related to Parkinson’s disease.
Please see additional Important Safety Information, including Boxed WARNING, at the end of the video.
[Slide]
The doctors and other individuals featured in this video were compensated by Acadia Pharmaceuticals Inc. for their participation.
Dr. Isaacson:
What does it mean to see things or believe things that aren't true? It really…is not a normal situation. It's very important to recognize that there's no such thing as…benign [hallucinations and delusions], that when you begin to believe things or see things that aren't really there, it's not normal.
[Slide]
Acadia presents
The Inflection Point
When to initiate treatment
Dr. Isaacson:
Parkinson's related hallucinations and delusions is…more common than we've thought about in the past.
Dr. Bahroo:
I could say approximately up to 50% of individuals will experience hallucinations or delusions throughout the course of their disease.
Dr. Isaacson:
They can begin much earlier than we recognize. They often begin with milder symptoms, illusions…when you see something but it's interpreted in a different way. The shoe on the floor looks like a mouse or the tie on the floor looks like a snake, a tree out the window looks like a person.
Dr. Chepke:
PD related hallucinations and delusions are usually progressive as well. So…the hallucination or delusion….the patient is able to report….is just the tip of the iceberg.
Dr. Patel:
Let me tell you about a patient I recently saw….I got a consult because the facility was worried about her having…visual hallucinations. So when I interviewed the patient, she told me about these bouquets of flowers she was seeing, and you would think bouquets of flowers, that's so pretty. But she was seeing bouquets of flowers on the face of her son who was visiting her every day. She was seeing bouquets of flowers on her food tray…bouquets of flowers on the puzzle pieces.
We did a medical workup.
Before diagnosing PD-related hallucinations and delusions, I screen out other causes.
It was not related to any delirium or any acute infection. We looked at her medication list. She was not on any anticholinergic, benzodiazepines, any pain medications.
She had insight, so I educated her related to how these visual hallucinations were related to her Parkinson's disease.
Dr. Chepke:
When the diagnosis of PD related hallucinations or delusions is made, we have to figure out if it's time to start treatment or not.
What I tend to look for is what I call the inflection point. When I notice that there's an increase in, could be frequency, could be the intensity or potentially the number of the different symptoms that they're having…I start to anticipate that that inflection point is going to mean that in the near future I expect that there's a good chance that it's going to become something that is very distressing to the patient.
Dr. Isaacson:
Are the symptoms slowly getting worse? Are they increasing in frequency, in severity? Is insight beginning to wane?...are they causing distress to daily life? Are they preventing patients from doing activities or leaving the home? Are they causing stress with family or caregivers?...And if we see that it's increasing, we can probably suppose it's going to continue to increase, and we probably should want to intervene sooner since it's progressing over time.
Dr. Chepke:
I get help from the patient and the family…because inflection points often happen in between office visits. I tell them, if you think that this is about to start getting…problematic, give me a call.
Dr. Patel:
She could not really have a meaningful visit with her son. She could not watch television. It was disrupting her ability to eat, the things she would love to do…She could not do her bingo because she was seeing bouquets of flowers on her bingo card. I mean, it was so distressing that she told me all she could do was put herself to sleep during the day, out of frustration, out of exhaustion.
Dr. Bahroo:
As hallucinations progress, hallucinations become more malignant, individuals become more enrobed in their alternate reality. And it is difficult for them to start treatment.
Dr. Patel:
They may get suspicious…or…refuse to take the medication.
Dr. Isaacson:
The last thing we want is to get that phone call that…our patient…or the family had to call 911 overnight and they had to be hospitalized.
We want to intervene, I think, before that point…we want to catch them early and try to address them sooner.
Dr. Patel:
I was able to initiate treatment by…educating the family that it was related to…Parkinson's disease. The family…was very understanding because they were actually seeing the implications of hallucination and delusion on their loved one.
We…initiated NUPLAZID 34 milligrams [once a day].
Dr. Chepke:
In…the clinical trial data for NUPLAZID, there was demonstration of…efficacy, but without the cost of a worsening in motor function. That's very important to…patients and their families. They don't want to see their loved one struggle and take steps backward with their motor function when introducing any new treatment option.
Dr. Patel:
When I saw her sitting in the courtyard with her daughter, her daughter held my hand and said, I wanted to thank you. My mom is really doing so well. This was a month later, and she rarely now sees the flowers….so she was so happy that her mother had responded so well.
[Slide]
ImportantSafety Information
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
[Voiceover]
- 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 who experience psychosis unless their hallucinations and delusions are related to Parkinson’s disease.
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 (e.g., Class 1A antiarrhythmics, Class 3 antiarrhythmics, certain antipsychotics or 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 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 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.
Dosage and Administration
Recommended dose: 34 mg capsule taken orally once daily, without titration, with or without food.
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please read the full Prescribing Information, including BOXED WARNING, also available at NUPLAZIDhcp.com.
©2023 Acadia Pharmaceuticals Inc. Acadia and NUPLAZID are registered trademarks of Acadia Pharmaceuticals Inc. All other trademarks are property of their respective owners. All rights reserved.
NU-2574 09/23.
