Serivan 17

Indicated for treatment of, hallucinations, delusions, associated with, Parkinson disease, psychosis

May take with or without food

Parkinson Disease Psychosis Indicated for treatment of hallucinations and delusions associated with Parkinson disease psychosis 34 mg PO qDay (without titration) Hepatic impairment No dosage adjustment recommended

Renal impairment Mild-to-moderate (CrCl ?30 mL/min): No dosage adjustment required Severe (CrCl <30 mL/min) or end stage renal disease: Use with caution

Documented hypersensitivity reaction to drug or components; rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea)

Selective serotonin inverse agonist and antagonist activity preferentially targeting 5-HT2A receptors believed to play an important role in psychosis

Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis Pimavanserin is a substrate of CYP3A4; strong CYP3A4 inhibitor or inducers affect systemic exposure

1-10% Nausea (7%) Peripheral edema (7%) Confusional state (6%) Hallucinations (5%) Constipation (4%) Gait disturbance (2%)

Pregnancy There are no data for use in pregnant women that would allow assessment of the drug-associated risk of major congenital malformations or miscarriage In animal reproduction studies, no adverse developmental effects were seen when pimavanserin was administered orally to rats or rabbits during the period of organogenesis at doses up to 10 or 12 times the maximum recommended human dose (MRHD) of 34 mg/day, respectively Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition