START THE CONVERSATION

Transcription

1 START THE CONVERSATION ABOUT PARKINSON S DISEASE PSYCHOSIS Your patients with Parkinson s disease (PD) psychosis may be hesitant to report their symptoms LEARN MORE about how to identify the symptoms of PD psychosis and ways to initiate a dialogue with patients and caregivers Indication NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson s disease psychosis. 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. See additional Important Safety Information on last page. Please read the accompanying full Prescribing Information including Boxed WARNING.

2 PD psychosis is a common nonmotor symptom of PD 1 PD psychosis is a serious and challenging condition that is often unrecognized and underreported 2 Patients with PD who will develop >50% 10% to psychosis over 20% the course of their disease 1 Patients with PD psychosis who spontaneously report symptoms to their physicians 2,3 Caregivers will often not be aware of and/or not report symptoms of psychosis 4 A review of patient data from the Rush Movement Disorder Parkinson s Disease Registry showed that while patients may initially have hallucinations with insight, they may worsen over time 5* * Clinical worsening was defined as a demonstration of hallucinations with loss of insight, or delusions, as measured by the Unified Parkinson s Disease Rating Scale (UPDRS). Initiating and maintaining a dialogue may help you monitor your patients for signs of progression and help them overcome feelings of stigma. 5,6 Contraindication: NUPLAZID is contraindicated in patients with a history of hypersensitivity reaction to pimavanserin or any of its components. Reactions have included rash, urticaria, tongue swelling, circumoral edema, and throat tightness. 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%). See additional Important Safety Information on last page. Please read the accompanying full Prescribing Information including Boxed WARNING.

3 Identify the symptoms of PD psychosis Open a dialogue about PD psychosis with patients and their caregivers QUESTIONS FOR PATIENTS 1. Have you seen, heard, or smelled things, such as people, animals, or objects, that were, in fact, not there? 2. Have you had any experiences such as the vivid sensation of somebody in the room with you, or a brief vision of movement, when there was nothing there? 3. Have you looked at something and seen it appear as something else for a time? For example, words on a page appearing as insects? 4. Have you had any beliefs or fears such as your loved one abandoning you, being unfaithful, or stealing from you? QUESTIONS FOR CAREGIVERS/FAMILY 1. Has your loved one seen things, heard things, or felt things that weren t actually there? 2. Has your loved one experienced any false beliefs toward you or anyone else, such as believing someone is stealing from them or infidelity? 3. Have these false beliefs or visualizations affected your daily lives? Questions for patients have been adapted from the Queen Square Visual Hallucination Inventory. 1

4 Identify the symptoms of PD psychosis in long-term care Open a dialogue about PD psychosis with residents and their caregivers QUESTIONS FOR RESIDENTS 1. Have you seen, heard, or smelled things, such as people, animals, or objects, that were, in fact, not there? 2. Have you had any experiences such as the vivid sensation of somebody in the room with you, or a brief vision of movement, when there was nothing there? 3. Have you looked at something and seen it change its appearance as you were looking at it? For example, words on a page appearing as insects? 4. Have you had any beliefs or fears such as your loved one abandoning you or stealing from you? QUESTIONS FOR PROFESSIONAL CAREGIVERS 1. Has your resident mentioned (or have you witnessed) speaking or reacting to people or pets in their personal space that aren t actually there? 2. Has your resident accused you, other staff members, or roommates of things that are false, such as believing someone is stealing from them, or refusing to take medications or eat for fear of being poisoned? 3. Has your resident become more withdrawn or unwilling to participate in therapies or attend recreational or social activities? Questions for patients have been adapted from the Queen Square Visual Hallucination Inventory. 1 Reference: 1. Williams DR, Warren JD, Lees AJ. Using the presence of visual hallucinations to differentiate Parkinson s disease from atypical parkinsonism. J Neurol Neurosurg Psychiatry. 2008;79: ACADIA Pharmaceuticals Inc. All rights reserved. NU /17.

5 KEEP THE CONVERSATION GOING AT NUPLAZIDHCP.com Visit NUPLAZIDHCP.com to learn more about the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson s disease psychosis. 7 Indication NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson s disease psychosis. 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 hypersensitivity reaction to pimavanserin or any of its components. Reactions have included rash, urticaria, tongue swelling, circumoral edema, and throat tightness. 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. Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment. Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA You can also call ACADIA Pharmaceuticals Inc. at ACADIA ( ). References: 1. Forsaa EB, Larsen JP, Wentzel-Larsen T, et al. A 12-year population-based study of psychosis in Parkinson disease. Arch Neurol. 2010;67(8): Fénelon G, Mahieux F, Huon R, Ziégler M. Hallucinations in Parkinson s disease: prevalence, phenomenology and risk factors. Brain. 2000;123(4): Fénelon G, Alves G. Epidemiology of psychosis in Parkinson s disease. J Neuro Sci. 2010;289(1-2): Chaudhuri KR, Prieto-Jurcynska C, Naidu Y, et al. The nondeclaration of nonmotor symptoms of Parkinson s disease to health care professionals: an international study using the nonmotor symptoms questionnaire. Mov Disord. 2010;25(6): Goetz CG, Fan W, Leurgans S, Bernard B, Stebbins GT. The malignant course of benign hallucinations in Parkinson disease. Arch Neurol. 2006;63(5): Ravina B, Marder K, Fernandez HH, et al. Diagnostic criteria for psychosis in Parkinson s Disease: report of an NINDS, NIMH Work Group. Mov Disord. 2007;22(8): NUPLAZID (pimavanserin) prescribing information, ACADIA ACADIA Pharmaceuticals Inc. All rights reserved. NU /17.