Dosage & Administration
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Nuplazid Prescribing Information
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia who experience psychosis unless their hallucinations and delusions are related to Parkinson's disease [see Warnings and Precautions (5.1)].
NUPLAZID® is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis [see Clinical Studies (14)].
Recommended Dosage
The recommended dose of NUPLAZID is 34 mg taken orally once daily, without titration.
Administration Information
NUPLAZID can be taken with or without food [see Clinical Pharmacology (12.3)].
NUPLAZID capsules can be taken whole, or opened and the entire contents sprinkled over a tablespoon (15 mL) of applesauce, yogurt, pudding, or a liquid nutritional supplement. Consume the drug/food mixture immediately without chewing; do not store for future use.
Dosage Modifications for Concomitant Use with CYP3A4 Inhibitors and Inducers
- Coadministration with Strong CYP3A4 Inhibitors
The recommended dose of NUPLAZID when coadministered with strong CYP3A4 inhibitors is 10 mg, taken orally as one tablet once daily [see Drug Interactions (7.1)].
- Coadministration with Strong or Moderate CYP3A4 Inducers
Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID [see Drug Interactions (7.1)].
NUPLAZID (pimavanserin) is available as:
- 34 mg strength capsules. The capsules are opaque white and light green with "PIMA" and "34" printed in black.
- 10 mg strength tablets. The orange, round, coated tablets are debossed on one side with a "P" and "10" on the reverse side.
Pregnancy
Risk Summary
There are no data on NUPLAZID 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. Administration of pimavanserin to pregnant rats during pregnancy and lactation resulted in maternal toxicity and lower pup survival and body weight at doses which are 2-times the MRHD of 34 mg/day [see Data].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data
Animal Data
Pimavanserin was not teratogenic in pregnant rats when administered during the period of organogenesis at oral doses of 0.9, 8.5, and 51 mg/kg/day, which are 0.2- and 10-times the MRHD of 34 mg/day based on AUC at mid and high doses, respectively. Maternal toxicity included reduction in body weight and food consumption at the highest dose.
Administration of pimavanserin to pregnant rats during pregnancy and lactation at oral doses of 8.5, 26, and 51 mg/kg/day, which are 0.14- to 14-times the MRHD of 34 mg/day based on AUC, caused maternal toxicity, including mortality, clinical signs including dehydration, hunched posture, and rales, and decreases in body weight, and/or food consumption at doses ≥26 mg/kg/day (2-times the MRHD based on AUC). At these maternally toxic doses there was a decrease in pup survival, reduced litter size, and reduced pup weights, and food consumption. Pimavanserin had no effect on sexual maturation, neurobehavioral function including learning and memory, or reproductive function in the first generation pups up to 14-times the MRHD of 34 mg/day based on AUC.
Pimavanserin was not teratogenic in pregnant rabbits during the period of organogenesis at oral doses of 4.3, 43, and 85 mg/kg/day, which are 0.2- to 12-times the MRHD of 34 mg/day based on AUC. Maternal toxicity, including mortality, clinical signs of dyspnea and rales, decreases in body weight and/or food consumption, and abortions occurred at doses 12-times the MRHD of 34 mg/day based on AUC.
Lactation
Risk Summary
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 NUPLAZID and any potential adverse effects on the breastfed infant from NUPLAZID or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness of NUPLAZID have not been established in pediatric patients.
Geriatric Use
No dose adjustment is required for elderly patients.
Parkinson's disease is a disorder occurring primarily in individuals over 55 years of age. The mean age of patients enrolled in the 6-week clinical studies with NUPLAZID [see Adverse Reactions (6.1)] was 71 years, with 49% 65-75 years old and 31% >75 years old. In the pooled population of patients enrolled in 6-week, placebo-controlled studies (N=614), 27% had MMSE scores from 21 to 24 compared to 73% with scores ≥25. No clinically meaningful differences in safety or effectiveness were noted between these two groups.
Patients with Renal Impairment
No dosage adjustment for NUPLAZID is needed in patients with mild to severe renal impairment or end stage renal disease (ESRD); however, increased exposure (Cmax and AUC) to NUPLAZID occurred in patients with severe renal impairment (CrCL <30 mL/min, Cockcroft-Gault) in a renal impairment study [see Clinical Pharmacology (12.3)].
NUPLAZID should be used with caution in patients with severe renal impairment and end stage renal disease.
In a renal impairment study, dialysis did not appear to significantly affect the concentrations of NUPLAZID [see Clinical Pharmacology (12.3)].
Patients with Hepatic Impairment
No dosage adjustment for NUPLAZID is recommended in patients with hepatic impairment based on the exposure differences observed in patients with and without hepatic impairment in a hepatic impairment study [see Clinical Pharmacology (12.3)].
Other Specific Populations
No dosage adjustment is required based on patient's age, sex, ethnicity, or weight. These factors do not affect the pharmacokinetics of NUPLAZID [see Clinical Pharmacology (12.3)].
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)].