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
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 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%).
Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) 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.
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.