Diminish the symptoms of Parkinson’s disease psychosis with once‑daily NUPLAZID 34 mg1

Dosing should be initiated at 34 mg without titration1

  • Patients take two 17-mg tablets together at any time of day for the full 34 mg recommended dose
  • Can be taken with or without food
  • The mean plasma half-life is approximately 57 hours, and steady-state concentration is typically achieved with 12 days of continuous therapy1,2
Hallucinations and delusions began to decrease as early as 2 weeks after starting NUPLAZID® (pimavanserin), but it may take 4-6 weeks to see full benefit.1

Use with other medications1

  • No dosage adjustment of carbidopa/levodopa is required when administered concomitantly with NUPLAZID®
  • In patients taking a strong CYP3A4 inhibitor, reduce the dosage of NUPLAZID to 17 mg
  • In patients taking a strong CYP3A4 inducer, monitor for reduced efficacy and consider increasing dosage of NUPLAZID
  • Avoid the use of NUPLAZID in combination with other drugs known to prolong QT interval
Dose adjustments are not needed on the basis of age, sex, ethnicity, or weight1*

* NUPLAZID is not recommended for use in patients with severe renal impairment (CrCL<30mL/min) or hepatic impairment

Meet Henry, an 89-year-old man, diagnosed with Parkinson’s disease 12 years ago. For the last several months, Henry has seen water seeping in from under the door, and is afraid that water will fill the entire room and drown him. His behavior worsens at sundown.

Actor portrayal

CURRENT MEDICATION

  • Carbidopa/levodopa for PD, but still experiencing significant gait disturbances, balance, and freezing issues
  • Atypical antipsychotic (low-dose), anticoagulant, MAO-B

CONSIDERATIONS

  • Recently diagnosed with dementia
  • Was just transferred to a long-term care facility because of his inability to take care of himself
  • Unwilling to leave his room, afraid to bathe, unable to use the toilet or groom himself due to hallucinations
  • Prescribed an atypical antipsychotic for hallucinations, but symptoms have not resolved and medication was discontinued
When you see a patient like Henry, start treatment with NUPLAZID.

illustrative example

NUPLAZIDconnect™ makes it easy to get patients started on treatment.

Drug Interactions

Considerations for use with concomitant medications1

NUPLAZID can interact with drugs that cause QT interval prolongation or with strong CYP3A4 inhibitors and inducers1

QT INTERVAL PROLONGATION1

Clinical impact

  • Concomitant use of drugs that prolong the QT interval may add to the effects of NUPLAZID and increase the risk of cardiac arrhythmia

Intervention

  • Avoid the use of NUPLAZID in combination with other drugs known to prolong QT interval.
    Examples include:
    • Class 1A antiarrhythmics: quinidine, procainamide, disopyramide
    • Class 3 antiarrhythmics: amiodarone, sotalol
    • Antipsychotics: ziprasidone, chlorpromazine, thioridazine
    • Antibiotics: gatifloxacin, moxifloxacin

STRONG CYP3A4 INHIBITORS1,3

Clinical impact1

  • Concomitant use of NUPLAZID with a strong CYP3A4 inhibitor increases pimavanserin exposure

lntervention1,3

  • If NUPLAZID is used with a strong CYP3A4 inhibitor, reduce the dosage of NUPLAZID.
    Examples include:
    • ceritinib, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, posaconazole, ritonavir, telaprevir, telithromycin, voriconazole

STRONG CYP3A4 INDUCERS1,3

Clinical impact1

  • Concomitant use of a strong CYP3A4 inducer may reduce pimavanserin exposure, resulting in a potential decrease in efficacy

Intervention1,3

  • Patients should be monitored for reduced efficacy and an increase in dosage may be needed if NUPLAZID is used concomitantly with strong CYP3A4 inducers.
    Examples include:
    • cabamazepine, enzalutamide, fosphenytoin, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifabutin, rifampin (rifampicin), rifapentine, St. John's wort


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 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.

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

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.

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. Data on file, ACADIA.
  3. Cytochrome P450 3A4 (CYP3A4) inhibitors and inducers. UpToDate website.
    https://www.uptodate.com/contents/image?imageKey=CARD/76992&v. Accessed June 21, 2016.