NUEDEXTA use in specific populations31

Geriatric use31

  • 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 years
  • Clinical studies of NUEDEXTA did not include sufficient numbers of patients aged ≥65 years to determine whether they respond differently than younger patients
No dose adjustments are required in patients with
mild-to-moderate renal or hepatic impairment31

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

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.