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Pimavanserin Tartrate

Also known as: Nuplazid

Route: Oral

Check Pimavanserin Tartrate Interactions →

4 interactions on record⛔ Black Box Warning

Pimavanserin Tartrate has 4 known drug interactions based on U.S. FDA drug labeling data. 3 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Class 1a Antiarrythmics, Class 3 Antiarrythmics, Strong Or Moderate Cyp3a Inducers. Patients taking Pimavanserin Tartrate should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Major: 3
Moderate: 1

Major (3)

Pimavanserin Tartrate + Class 1a Antiarrythmics— Concomitant use may add to QT prolongation effects and increase risk of cardiac arrhythmia.
Pimavanserin Tartrate + Class 3 Antiarrythmics— Concomitant use may add to QT prolongation effects and increase risk of cardiac arrhythmia.
Pimavanserin Tartrate + Strong Or Moderate Cyp3a Inducers— Reduces pimavanserin exposure; concomitant use should be avoided.

Moderate (1)

Pimavanserin Tartrate + Mao Inhibitors— Increases pimavanserin exposure; dosage reduction of NUPLAZID required.

Pimavanserin Tartrate + Class 1a Antiarrythmics⚠️Major

Concomitant use may add to QT prolongation effects and increase risk of cardiac arrhythmia.

Pimavanserin Tartrate + Class 3 Antiarrythmics⚠️Major

Concomitant use may add to QT prolongation effects and increase risk of cardiac arrhythmia.

Pimavanserin Tartrate + Strong Or Moderate Cyp3a Inducers⚠️Major

Reduces pimavanserin exposure; concomitant use should be avoided.

Pimavanserin Tartrate + Mao Inhibitors🟡Moderate

Increases pimavanserin exposure; dosage reduction of NUPLAZID required.

⛔ FDA Black Box Warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning . 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. ( 5.1 )

Contraindications

4 CONTRAINDICATIONS 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 )

Pregnancy & Breastfeeding

8.1 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

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.