NUPLAZID dosing

Start with NUPLAZID® (pimavanserin) 34 mg—the full therapeutic dose proven in clinical trials1

NUPLAZID 34 mg was the starting and maintaining dose used in the
Phase 3 pivotal trial (N=199)1

  • Hallucinations and delusions may begin to decrease as early as 2 weeks from baseline after starting NUPLAZID, with statistical significance seen at 4 and 6 weeks1,2
  • NUPLAZID can be taken with or without food1
  • No dose adjustment is required for elderly patients/residents or when used in combination with carbidopa/levodopa1
  • A dose adjustment may be required for patients taking strong CYP3A4 inhibitors or inducers1
  • Avoid the use of NUPLAZID in combination with other drugs known to prolong QT interval1

Per CMS guidelines, gradual dose reduction may be contraindicated for chronic psychological conditions such as PD psychosis.3-5

NUPLAZID 34 mg is self-titrating1

Full therapeutic-level steady-state plasma concentration was reached in 12 days with continuous treatment, without titration1,6*

  • Half-life (t½) is 57 hours1

Achieve the proven efficacy of NUPLAZID by starting patients on once-daily 34 mg without titration.1†

*Simulation of a typical concentration profile of NUPLAZID.

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

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 or inducers

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 INHIBITORS1,7

Clinical impact1

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

Intervention1,7

  • 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 INDUCERS1,7

Clinical impact1

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

Intervention1,7

  • 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:
    • carbamazepine, enzalutamide, fosphenytoin, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifabutin, rifampin (rifampicin), rifapentine, St. John's wort

Help your patients access NUPLAZID with NUPLAZIDconnect

Your patients can receive access and reimbursement support, benefits investigation, financial assistance options, and more.

LEARN MORE ABOUT NUPLAZIDCONNECT

Important Safety Information for NUPLAZID (pimavanserin) 17-mg Tablets

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 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.

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.

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

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 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.

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.

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. Cummings J, Isaacson S, Mills R, et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014;383(9916):533-540.
  3. US Centers for Medicare & Medicaid Services. State Operations Manual Pub 100-07. Appendix PP - Guidance to Surveyors for Long Term Care Facilities. Baltimore, MD: US Dept of Health and Human Services; 2017.
  4. 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):1061-1068.
  5. Goetz CG, Fan W, Leurgans S, Bernard B, Stebbins GT. The malignant course of “benign hallucinations” in Parkinson disease. Arch Neurol . 2006;63(5):713-716.
  6. Data on file, ACADIA.
  7. Cytochrome P450 3A4 (CYP3A4) inhibitors and inducers. UpToDate website.
    http://www.uptodate.com/contents/image?imageKey=CARD%2F76992&source=image_view&view=print&elapsedTimeMs=2. Accessed January 20, 2017.