Description

Strong CYP3A4 Inhibitors (e.g., ketoconazole): Reduce Pimavanserin dose by one-half. Strong CYP3A4 Inducers: Monitor for reduced efficacy. Increase in Pimavanserin dosage may be needed.

There are no data on Pimavanserin use in pregnant women that would allow assessment of the drug-associated risk of major congenital malformations or miscarriage. There is no information regarding the presence of pimavanserin in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Pimavanserin and any potential adverse effects on the breastfed infant from Pimavanserin or from the underlying maternal condition.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis. Analyses of 17 dementia-related psychosis placebo-controlled trials (modal duration of 10 weeks and largely in patients taking atypical antipsychotic drugs) revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in placebo-treated patients. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Pimavanserin is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis. QT Interval Prolongation: Pimavanserin prolongs the QT interval. The use of Pimavanserin should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin). Pimavanserin 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 the presence of congenital prolongation of the QT interval

Pediatric Use: Safety and effectiveness of Pimavanserin have not been established in pediatric patients. Geriatric Use: No dose adjustment is required for elderly patients. Renal Impairment: No dosage adjustment for Pimavanserin is needed in patients with mild to moderate (CrCL ≥30 mL/min, Cockcroft-Gault) renal impairment. Hepatic Impairment: Use of Pimavanserin is not recommended in patients with hepatic impairment. Pimavanserin has not been evaluated in this patient population.

Antiparkinson drugs

Store at 20°C to 25°C.