NUEDEXTA® use in specific populations1

Geriatric Use1

  • Systematic pharmacokinetic trials have not been done in elderly subjects (aged ≥65 years)
  • A population pharmacokinetic analysis including 170 subjects, of whom 22 were aged ≥65 years, revealed similar pharmacokinetics in older and younger subjects
  • Of the total number of patients with PBA in NUEDEXTA clinical studies, 14% were aged ≥65 years, while 2% were aged ≥75
  • Clinical studies of NUEDEXTA did not include sufficient numbers of patients aged ≥65 to determine whether they respond differently than younger patients

 

Renal or Hepatic Impairment

No dose adjustments are required in patients with mild-to-moderate renal or hepatic impairment1
  • Additional monitoring for adverse events in patients with mild or moderate hepatic impairment should be considered
  • NUEDEXTA has not been studied in patients with severe hepatic or renal impairment
  • Increases in dextromethorphan and/or quinidine levels are likely to be observed in patients with severe renal/hepatic impairment

 

Risk Factors

Risk factors should be considered when treating patients with NUEDEXTA. Elderly patients may be more prone to have multiple risk factors for adverse events such as cardiac compromise, hepatic or renal insufficiency, or drug interactions.

For additional information on these and other specific populations, please see the Full Prescribing Information.