Pimavanserin: uses, dosing, side effects & brands

The following serious adverse reactions are discussed elsewhere in the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] QT Interval Prolongation [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥5% and twice the rate of placebo): peripheral edema and confusional state. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acadia Pharmaceuticals Inc. at 1-844-422-2342 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical trial database for NUPLAZID consists of over 1200 subjects and patients exposed to one or more doses of NUPLAZID. Of these, 616 were patients with hallucinations and delusions associated with Parkinson's disease psychosis (PDP). In the placebo-controlled setting, the majority of experience in patients comes from studies evaluating once-daily NUPLAZID doses of 34 mg (N=202) compared to placebo (N=231) for up to 6 weeks. In the controlled trial setting, the study population was approximately 64% male and 91% Caucasian, and the mean age was about 71 years…

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 [see Adverse Reactions (6.2) ] . Known hypersensitivity to NUPLAZID or any of its components. ( 4 )

Strong CYP3A4 Inhibitors: Reduce NUPLAZID dose to 10 mg once daily. ( 2.3 , 7.1 ) Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of NUPLAZID. ( 2.3 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with NUPLAZID Table 2 Clinically Important Drug Interactions with NUPLAZID QT Interval Prolongation Clinical Impact: Concomitant use of drugs that prolong the QT interval may add to the QT 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 (e.g., Class 1A antiarrythmics, Class 3 antiarrythmics, certain antipsychotics or antibiotics) [see Warnings and Precautions (5.2) ] . Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of NUPLAZID with a strong CYP3A4 inhibitor increases pimavanserin exposure [see Clinical Pharmacology (12.3) ] . Intervention: If NUPLAZID is used with a strong CYP3A4 inhibitor, reduce the dosage of NUPLAZID [see Dosage and Administration (2.3) ]. Strong or Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of NUPLAZID with strong or moderate CYP3A4 inducers reduces pimavanserin exposure [see Clinical Pharmacology (12.3) ]. Intervention: Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID [see Dosage and Administration (2.3) ] . 7.2 Drugs Having No Clinically Important Interactions with NUPLAZID Based on pharmacokinetic studies, no dosage adjustment of carbidopa/levodopa is required when administered concomitantly with NUPLAZID [see Clinical Pharmacology (12.3) ] .