Most common adverse reactions in the pivotal trial1
Adverse events with NUEDEXTA were generally mild to moderate in nature.1,a
aAdverse reactions occurring in ≥5% of patients on NUEDEXTA and ≥2x placebo rate.
Adverse reactions leading to discontinuation1
The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) that led to discontinuation of NUEDEXTA were muscle spasticity (3%), respiratory failure (1%), abdominal pain (2%), asthenia (2%), dizziness (2%), fall (1%), and muscle spasm (2%).
Risk of falls1,2
- The incidence of falls with NUEDEXTA was similar to placebo; however, NUEDEXTA may cause dizziness
- Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls
These are not all the risks from use of NUEDEXTA.
Adverse events in the PRISM II open-label trial3
Reported adverse events (AEs) were generally consistent with the NUEDEXTA safety profile observed in the placebo-controlled pivotal trial.3
bAEs occurring in >1% of patients.
Serious AEs and AEs leading to study withdrawal3
- Serious AEs were reported in 6.3% of patients; none were considered treatment related by investigators
- 2 deaths were reported during the course of the study (2 males aged 91 and 83 with dementia). Both deaths were deemed not related to study drug
- In total, 36 (9.8%) participants had AEs that led to study withdrawal, most commonly for diarrhea (8 [2.2%]), dizziness, affective lability, and agitation (3 [0.8%] each)
These are not all the risks from use of NUEDEXTA
NUEDEXTA contains an ultra-low dose of quinidine1
The 20-mg daily dose (at Q12H dosing) of quinidine in NUEDEXTA is about 3% of the lowest recommended antiarrhythmic dose.4
NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, heart failure, patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (eg, thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker or at high risk of complete AV block.