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
Documented hypersensitivity reaction to drug or components; rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea)
Dose
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
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Selective serotonin inverse agonist and antagonist activity preferentially targeting 5-HT2A receptors believed to play an important role in psychosis
Interaction
N/A
Pregnancy Category Note
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
Adult Dose
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
Child Dose
N/A
Renal Dose
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
Administration
May take with or without food
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