NUEDEXTA safety profile

Most common adverse reactions in pivotal trial31

Adverse events (AEs) occuring in ≥5% baseline of patients on NUEDEXTA and ≥2x placebo rate

  NUEDEXTA (n=107) Placebo (n=109)
Diarrhea 13% 6%
Dizziness 10% 5%
Cough 5% 2%
Vomiting 5% 1%
Asthenia 5% 2%
Peripheral Edema 5% 1%
  • The incidence of falls with NUEDEXTA was similar to placebo; however, NUEDEXTA may cause dizziness31,32
  • Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls
  • AEs were generally mild to moderate in nature17

NUEDEXTA Adverse Events in PRISM II Open-Label Trial17

Frequency of AEs in >1% of patients; N=367 n (%)
Diarrhea 20 (5.4)
Headache 15 (4.1)
Urinary tract infection 10 (2.7)
Dizziness 9 (2.5)
Nausea 6 (1.6)
Fall 6 (1.6)
Fatigue 5 (1.4)
Somnolence 5 (1.4)

 

  • Most AEs were of mild or moderate intensity
  • Serious AEs were reported in 6.3%; none were considered treatment related by investigators
  • Reported AEs in PRISM II were generally consistent with the NUEDEXTA safety profile observed in the placebo-controlled clinical trials. For more information, refer to the Full Prescribing Information and Important Safety Information throughout this website
  • 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

 

NUEDEXTA cardiac safety profile

An Ultra-Low Dose of
Quinidine (10 mg)32

 

  • The 20-mg daily dose of quinidine is 1/30 of the lowest recommended antiarrhythmic dose of quinidine (600-1600 mg/day)20
  • No reports of treatment-related cardiac serious adverse events in PBA clinical trials4,21,32

 

IMPORTANT CARDIAC SAFETY INFORMATION

  • 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 (e.g., thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker or at high risk of complete AV block.31
  • Cardiac Effects: NUEDEXTA causes dose-dependent QTc prolongation. 
When initiating NUEDEXTA in patients at risk for QT prolongation and torsades
 de pointes, electrocardiographic (ECG) evaluation should be conducted at 
baseline and 3-4 hours after the first dose. Some risk factors include use with
 CYP3A4 inhibitors or drugs that prolong QT interval, electrolyte abnormalities,
 bradycardia, or left ventricular hypertrophy or dysfunction.31